• Ibogaine is a psychoactive alkaloid from the western Central African iboga shrub that can rapidly reduce, and sometimes eliminate, opioid withdrawal and craving symptoms within a single dose.
• Ibogaine is a potential breakthrough treatment for opioid use disorder (OUD) due to its unique ability to heal the neurochemical brain injury caused by opioid use and alleviate withdrawal symptoms.
• Opioid withdrawal syndrome (OWS) is the debilitating physical and neurological symptoms that are induced by the cessation of opioid consumption.
• Ibogaine has shown promising results in resolving OWS within 36 to 48 hours of administration under safe, clinically controlled conditions.

Ibogaine could reduce lifetime direct costs of OUD by nearly 90%

• A growing body of research suggests that ibogaine treatment for opioid use disorder (OUD) could be significantly more cost-effective than traditional medication-assisted treatments (MATs), such as methadone and buprenorphine (suboxone).
• Unlike MATs—which require long-term, or even lifelong, use—ibogaine offers a clear root-cause intervention, capable of disrupting OUD within a single dose. In one study, 30% achieved complete opioid abstinence after only one ibogaine session.
• Patients who discontinue MATs often relapse when opioid withdrawal and craving symptoms return. MAT success is therefore measured on program retention (or continuation) instead of abstinence.
• The comparative cost-analysis below predicts that ibogaine treatment for OUD could reduce the 20-year direct lifetime costs of MATs involving methadone and buprenorphine by 87% and 86%. Concurrently, this analysis reveals just how quickly per-patient costs for MATs exceed $100,000.

Cost-Effectiveness for OUD Treatment: Ibogaine vs. MATs

Download the full backgrounder here:

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• Ibogaine is a psychoactive compound derived from the root bark of the Central African shrub Tabernanthe iboga, which has long been used in spiritual practices.  

• A growing body of scientific research is demonstrating the promise of ibogaine as an unconventional, but effective, treatment option for a wide range of mental health and neurological conditions, including opioid use disorder (OUD), post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), depression, anxiety, multiple sclerosis (MS), and more. 

• Despite such wide-ranging potential, ibogaine’s classification as a Schedule I drug makes it difficult to study and presents a major federal roadblock toward expanding rigorous scientific research into innovative treatment approaches that can improve veterans’ lives and transform state spending on addiction and other mental health conditions. 

The promise of ibogaine treatment for mental health, addiction  

• Research by Stanford University published in Nature Medicine in 2024 found that ibogaine treatment immediately led to significant improvements in PTSD, depression, and anxiety in a cohort of 30 special operations veterans suffering from TBI.  

• The results were profound. According to Stanford Medicine, “[o]ne month after treatment participants experienced average reductions of 88% in PTSD symptoms, 87% in depression symptoms and 81% in anxiety symptoms,” relative to their condition prior to treatment.  

• Cognitive testing also revealed improved concentration, information processing, memory, and impulsivity among the veterans participating in the study.  

• A consistent theme emerges from clinical studies assessing ibogaine for opioid use disorder: ibogaine and ibogaine analogues are the only known treatments that consistently and immediately reduce both physical withdrawal symptoms from opioid addiction and psychological dependence without the need for ongoing medication.

• In a small-scale study, 75% of patients remained abstinent from opioids for an entire year following treatment. Ibogaine-assisted therapy has the potential to provide lasting anti-addictive effects after only one or two doses, potentially reducing relapse rates and associated mortality risk. This is particularly beneficial given the shortcomings of traditional treatments for OUD, such as methadone and buprenorphine.  

Emerging state interest in ibogaine’s treatment potential 

• Colorado voters decriminalized ibogaine in 2022, and the state’s Natural Medicine Advisory Board will consider adding ibogaine to its regulated, facilitated psychedelics access program in 2026. 

• Policymakers in several states—including Texas, Arizona, Ohio, Washington, and West Virginia—introduced legislation in 2025 to allocate state funds (including those drawn from states’ opioid settlement funds) toward clinical research trials that would demonstrate ibogaine’s potential for treating OUD and other mental health conditions.  

Takeaway: Ibogaine has the potential to transform the lives of millions of Americans struggling with addiction and mental health challenges. States can enact sensible legislation that advances research and development while maintaining a strong commitment to public safety and health. 

Read the full backgrounder:

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We believe that studying ibogaine would be beneficial for mental health and addiction care. If ibogaine demonstrates both safety and efficacy, it could facilitate treatment access to millions of Americans suffering from opioid use disorder (OUD) and other mental health conditions. We believe that Senate Bill 2308 provides a sensible regulatory pathway for the advancement of ibogaine as a potential treatment for OUD, co-occurring substance use disorders (SUD), and other relevant neurological or mental health conditions.

Texas can lead the nation in innovative mental health and addiction care solutions with this bill. Senate Bill 2308 prioritizes patient safety and scientific rigor. There are strict requirements for all applicants wishing to conduct trials. To be eligible for the grant, applicants must be private corporation entities with enough capacity and financial resources to conduct FDA trials, seek FDA approval, and conduct future trials. Applicants must also provide detailed plans on trial design, participant recruitment, safety protocols, post-treatment aftercare, and strategy for FDA-approval.

Senate Bill 2308 does not attempt to legalize ibogaine or ibogaine treatment, nor does it try to bypass existing federal regulations. It would retain current prohibitions on possession, use, manufacture, and sale of psychedelic compounds, as well as provide a framework consistent with the FDA drug-approval process, as ibogaine treatment administration will only apply if FDA approval is granted, requiring licensed physicians to supervise its administration in healthcare facilities.

 Over the past decade, the medical community has increasingly recognized the potential of psychedelic therapies for the treatment of mental health conditions and addiction. However, despite promising research, access to innovative psychedelic therapies is limited by the FDA’s designation of psychedelics as Schedule I substances. Ibogaine appears to have a unique ability to rapidly reduce withdrawal and craving symptoms associated with opioid addiction, often after just a single dose.

The grant program under SB 3208 offers an opportunity to collect comprehensive safety and efficacy data on ibogaine for treating OUD, SUD, and other mental health disorders, while ensuring alignment with existing federal regulations and FDA drug approval standards.

While not necessarily a major point of concern, we’d like to note that Senate Bill 3208 contains slightly different language regarding funding sources than its companion bill, House Bill 3717.  The House Bill allows for funding from both appropriated money and gifts, grants, or donations, while the Senate Bill only allows for funding from gifts, grants, or donations. The House language may provide additional flexibility for the funding of ibogaine studies, potentially allowing for the use of resources such as opioid settlement funds. This broader funding approach could enhance the program’s impact and success.

Overall, SB 3208 would allow Texas to administer grants to conduct potentially life-saving research into ibogaine, which has shown tremendous promise in the therapeutic treatment of OUD, with minimal risk to both public safety and public health. Thank you for your time and consideration.

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Senate Bill 751 proposes the creation of a time-limited, geographically restricted pilot program to investigate the use of psilocybin services for veterans and inactive first responders facing post-traumatic stress disorder (PTSD), end-of-life distress, or related conditions. We believe that SB 751 provides a sensible regulatory framework that prioritizes safety, efficacy, and ethical standards and operates within current federal regulations.

Reason Foundation has comprehensively reviewed the available scientific literature on psilocybin and found that it presents a strong safety profile. Specifically, psilocybin is associated with low physiological toxicity, minimal risk of abuse or addiction, generally well-tolerated psychological effects, and no evidence of lasting harmful physiological or psychological outcomes.

As noted in SB 751’s legislative findings section, “every day, an average of 17.6 veterans commit suicide. … First responders, including law enforcement officers and firefighters, are more likely to die by suicide than in the line of duty.” These stark statistics reflect the inadequacy of existing treatment options for trauma-related mental health conditions and underscore the need to explore promising alternatives.

SB 751 ensures compliance with FDA and DEA regulations

SB 751 does not legalize psilocybin but instead creates a narrowly tailored exception to support federally compliant research. The program would operate in up to five California counties under the oversight of the California Health and Human Services Agency and in partnership with the University of California system. Local pilot sites must also partner with community-based providers already serving veterans and first responders, ensuring the program is embedded within existing support networks.

Importantly, Section 2 requires strict safety protocols aligned with the most current Food and Drug Administration (FDA) and Drug Enforcement Administration guidelines for psychedelic clinical trials. University partners would be responsible for designing research protocols, obtaining Institutional Review Board approvals, training facilitators, and collecting clinical data. This structure prioritizes ethical standards, qualified supervision, and scientific integrity.

SB 751 prioritizes transparency, efficacy, and safety

SB 751 ensures transparent partnerships between local pilot programs and participating universities. Sec. 11315(a) states, “[T]he agency shall enter into an agreement with each university partner approved for participation in the pilot program.” The agreement shall specify “the amount of funding available to the local pilot; the conditions under which payments will be made; data collection and sharing requirements; and reporting requirements.”

This bill also includes a clear framework for monitoring, evaluation, and long-term transparency. Sec. 11316(a) requests university partners to submit mid-year annual reports to the California Health and Human Services Agency. By 2029, university partners must also jointly select an independent third-party evaluator to conduct a peer-reviewed statewide study of the program’s efficacy and community impact. By January 15, 2030, the California Health and Human Services Agency is required to compile a comprehensive report to the legislature, including program outcomes, data analysis, and recommendations.

The promise of psychedelic-assisted therapy

Over the past decade, the medical community has increasingly recognized the potential of psychedelic therapies for the treatment of mental health conditions. In controlled clinical settings, psychedelics have exhibited fewer safety concerns than many standard pharmaceutical drugs. Research suggests that psychedelics are non-addictive and carry a low risk of abuse. 

In 2023, Reason Foundation comprehensively reviewed existing FDA clinical trials examining psilocybin for mental health conditions. Our research concluded that psilocybin offers promise for a range of additional disorders, including PTSD, anxiety due to terminal illness, neurodegenerative disease, obsessive-compulsive disorder, and drug dependency, in addition to its potential therapeutic efficacy in treating depression.

However, despite promising research, access to innovative psychedelic therapies is limited by the FDA’s designation of psychedelics as Schedule I substances.

Conclusion

SB 751 presents a cautious, evidence-based pathway to study whether psilocybin-assisted therapy can offer a meaningful improvement in the treatment of trauma-related mental health conditions. By centering this work within academic and clinical frameworks—and ensuring strong oversight and federal compliance, California can responsibly contribute to the development of potentially life-saving therapies for some of the most vulnerable populations.

Right now, many veterans and first responders are traveling outside the United States—often to countries like Mexico or Peru—to access psychedelic therapies that they credit with saving their lives. Those who have spent their lives defending our freedoms shouldn’t be forced to cross borders to access healing.

If this pilot program proves successful and psilocybin services are effective and safe, California will be well-positioned to expand access to these therapies to other populations struggling with mental health conditions. States like Colorado, Oregon, and New Mexico have already taken steps in this direction, and California could build on these efforts by developing an evidence-based, compassionate model for broader access.

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Legislative Document 1034 represents a modest step forward in drug policy reform by decriminalizing personal possession of therapeutic amounts of psilocybin for adults. This bill does not create a commercial market or legalize retail sales—it only removes criminal penalties for adults who possess small, personal-use amounts of psilocybin.

Reason Foundation has comprehensively reviewed the available scientific literature on psilocybin and found that it presents a strong safety profile. Specifically, psilocybin is associated with low physiological toxicity, minimal risk of abuse or addiction, generally well-tolerated psychological effects, and no evidence of lasting harmful physiological or psychological outcomes.

In clinical settings, psilocybin has shown promise in treating depression, anxiety, PTSD, substance use disorders, neurological disorders, and end-of-life distress. Studies also consistently show that the psilocybin experience can lead to lasting improvements in mental health, with patients often describing the experience as among the most personally meaningful of their lives.

We believe adults should not be criminalized for seeking out the therapeutic benefits of psilocybin.

LD 1034 creates space for broader policy conversations

As other states have begun to explore safe, regulated access pathways for psychedelic compounds, Maine now has an opportunity to consider frameworks that ensure both personal freedom and public health protections.

Future legislation could explore a license-type model that allows trained facilitators to guide individuals through psilocybin experiences in supported settings. These models promote safety, informed use, and equitable access while still exploring promising alternative treatments.

Reason Foundation has been actively engaged in policy conversations surrounding psychedelic-assisted therapy and access models across the country. We would welcome the opportunity to support Maine in developing a regulatory framework that reflects the latest scientific evidence and centers patient well-being.

Conclusion

Psilocybin is safe, and adults should not face criminal punishment for seeking its therapeutic effects. LD 1034 creates an opening for more robust, regulated approaches to mental health care in the future. We urge the committee to support this bill and consider Maine’s role as a leader in safe, forward-thinking psychedelic policy.

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An Alternative Therapy Pilot Program could expand access to innovative treatments for individuals suffering from mental health conditions in Nevada. While this program would be limited to veterans and first responders, this population could be expanded once safety and efficacy standards are met. In particular, research compiled by the Reason Foundation shows that various psychedelic therapies show far greater promise in combatting depression and opioid addiction than existing therapies and that periodic psychedelic therapy may also allay the onset and reduce the severity of common neurodegenerative diseases like Alzheimer’s or Parkinson’s.

Psychedelics show the potential to be more effective than conventional drugs currently being used to treat a range of mental health disorders. In controlled clinical settings, psychedelics have also exhibited fewer safety concerns than many standard pharmaceutical drugs. Research suggests that psychedelics are non-addictive and carry a low risk of abuse. However, despite promising research, access to innovative psychedelic therapies is limited by the FDA’s designation of psychedelics as Schedule I substances.  

The current Schedule I designation hinders scientific research by discouraging research institutions from investigating psychedelic treatments, as well as potential financial supporters from investing money that could implicate them as accomplices to a federal crime. However, the Alternative Therapy Pilot Program could collect comprehensive safety and efficacy data on alternative psychedelic therapies without imposing legal risks on its participants.  

Under Assembly Bill (AB) 378, the Nevada Division of Public and Behavioral Health would be responsible for developing clinical guidelines, licensing requirements, and oversight mechanisms for the pilot program. The bill explicitly states, “To the extent consistent with federal law, the Division shall take all actions which are feasible to ensure that all pilot clinic programs developed and implemented under the Program comply with all applicable federal requirements or guidelines relating to the clinical or experimental use of controlled substances.” 

Psychedelic substances such as psilocybin, DMT, ibogaine, and mescaline could only be administered under medical supervision at licensed facilities. Patients would be required to meet strict eligibility criteria and receive treatment in conjunction with supportive services. The legislation also requires the division to license at least one entity to cultivate or manufacture the psychedelic substances necessary for the program.  

Under AB 378, participants who manufacture, cultivate, administer, or receive psychedelic substances under its program would be protected from civil, criminal, and administrative penalties, provided their actions remain within the program’s scope.  

AB 378 would establish a program that ensures compliance with all relevant federal research and safety guidelines while protecting its participants from legal risks. It would permit psychedelic-assisted therapy under medical supervision, with safeguards that allow Nevada to carefully study outcomes and expand access over time. These changes offer a great deal of promise to citizens who may be struggling with mental health problems. 

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Reason Foundation is committed to ensuring that health policies encourage innovation in addiction treatment, expand access to promising therapies and provide patients with alternative treatment options. Ibogaine represents a potential breakthrough in addressing the U.S. opioid crisis.

As noted in Senate Bill 5204, ibogaine has shown promising potential as a treatment for opioid use disorder (OUD) but remains largely understudied due to its Schedule I classification. Reason Foundation has comprehensibly reviewed the available scientific evidence regarding ibogaine’s effectiveness relative to existing treatment options and compiled this evidence into a guide for policymakers. Our work provides support for claims in the legislative findings section in S.B. 5204 that “ibogaine appears to have the unique ability to rapidly reduce withdrawal and craving symptoms associated with opioid addiction, often after just a single dose.”  We find that this is particularly beneficial given the shortcomings of traditional treatments for OUD. Medication-assisted treatments (MATs), which typically involve either methadone or buprenorphine coupled with naloxone, for OUD are associated with high relapse rates following cessation and high mortality rates. In short, these treatments have small success rates.

MATs require daily clinical visits and a commitment to long-term treatment, which may not be feasible or effective for patients recovering from addiction. Existing MATs are not highly effective in reducing withdrawal and craving symptoms following the cessation of opioid use, leading to high relapse rates. Studies indicate that most patients relapse within one month of initiating buprenorphine maintenance therapy (BMT), with young adults and primary prescription opioid users experiencing high relapse rates.  Similarly, a comparison of buprenorphine/naloxone vs. methadone results revealed that 50.9% and 41.1% of patients, respectively, had reverted to heroin or opiate use throughout the 15-month follow-up period.

Long-term retention of MAT patients remains a challenge. Patients must maintain treatment for around two years to be successful, but most methadone patients maintain treatment for less than one year and buprenorphine treatments average less than three months. Retention rates beyond six months are typically below 50%, and continuous abstinence for a year is generally no greater than 51% in large state-level programs.

Patients who stop or are disenrolled from MATs face a significantly higher risk of fatal overdose. Some long-term studies have reported alarmingly high death rates, reaching up to 50%. A large-scale review of 122,885 patients found that mortality rates were much higher for those receiving outpatient treatment compared to inpatient care. Specifically, the all-cause mortality rate was 36.1 deaths per 1,000 person-years for patients in outpatient methadone treatment, compared to 11.3 per 1,000 in inpatient programs. For buprenorphine, outpatient treatment had a mortality rate of 9.5 per 1,000 person-years, while inpatient treatment had a lower rate of 4.3 per 1,000.

Overdose-specific mortality followed the same pattern: 12.7 per 1,000 for outpatient methadone patients versus 2.6 per 1,000 for inpatient, and 4.6 per 1,000 for outpatient buprenorphine compared to 1.4 per 1,000 in inpatient care.

A major advantage of ibogaine treatment is that it demonstrates high success rates after only a single administration, unlike traditional MATs that require ongoing, long-term use. In a small-scale study, 75% of patients remained abstinent from opioids for an entire year following treatment. Ibogaine-assisted therapy has the potential to provide lasting anti-addictive effects with fewer doses, potentially reducing relapse rates and associated mortality rates. The U.S. opioid crisis is growing increasingly worse, and expanding research into ibogaine could provide an innovative treatment approach that addresses the shortcomings of MATs.

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The Drug Enforcement Administration’s (DEA’s) acknowledgment that more Dimethyltryptamine (DMT) is needed for research is a good sign for the development of psychedelic therapies. Early clinical evidence suggests DMT psychedelic-assisted therapies could potentially treat mental health disorders, such as major depression and brain injuries resulting from strokes.  

DMT is a naturally occurring compound found in various plants and animals, and it is known for its mind-altering properties. It’s the main psychoactive ingredient found in ayahuasca—a ceremonial tea—and has been historically used by indigenous cultures for religious ritual and therapeutic purposes. Today, synthetic DMT is produced in labs, and while many associate it with recreational use and its powerful, short-lived “breakthrough” experiences, emerging research suggests its potential as a medicinal drug.

One of the main concerns surrounding DMT is its safety, but recent research may ease some fears.  A 2022 London clinical trial investigating DMT-assisted therapy for Major Depressive Disorder (MDD) revealed no serious drug-related adverse events, concluding that DMT-assisted therapy has a favorable safety and tolerability profile in proper clinical settings. All of the reported side effects were minimal and short-lived. Of 20 drug-related adverse events, all were mild (85%) or moderate (15%) and resolved rapidly and independently. Moreover, there were no significant negative effects on anxiety and well-being reported at any point during the three-month follow-up. None of the participants expressed any regrets, and most of them reported their experience as pleasurable and not too challenging.

In Canada, where the government can more easily allow companies to research uses of controlled substances than in the United States, DMT-assisted therapy research has shown promising preliminary evidence for treating brain injuries resulting from strokes. Algernon Pharmaceuticals Inc., a Canadian clinical-stage pharmaceutical development company, recently announced its plans to advance with its DMT stroke research program as its lead asset.

Christopher J. Moreau, CEO of Algernon, stated, “Investigating neuroplasticity in a clinical setting, as a potential new treatment approach for … stroke patients, is a new and promising area of research.” The company decided to advance into a Phase 2 study based on positive data from their Phase 1 trial. Phase 1 results demonstrated that a six-hour DMT infusion could achieve levels linked to neuroplasticity (the brain’s ability to change and adapt) in preclinical studies without causing a psychedelic experience.

In some countries, including England and Canada, early research suggests DMT-assisted treatments have therapeutic value and favorable safety profiles, permitting further investigation into DMT’s pharmaceutical potential. However, in the U.S., research on psychedelic drugs, such as DMT, is hindered by their classification as Schedule I substances under the federal Controlled Substances Act—drugs deemed by the government to have no currently accepted medical use and a high potential for abuse. 

Any drug seeking approval must first present significant clinical evidence showing that it meets FDA safety and efficacy standards. However, Schedule I drugs face significant barriers to research and development, making it much more difficult for them to demonstrate what the FDA demands. The FDA deems DMT and other psychedelics as inherently “dangerous,” and federal law prohibits the manufacture, distribution, dispensation, and possession of Schedule I substances except for federal government-approved research studies. This criminal status under federal law has a chilling effect on companies and investors who might otherwise be willing to deploy resources into further research. As a result, private investment in the development of these drugs is limited, and psychedelics researchers often find themselves pleading for public funding.

The DEA’s recognition that more DMT is needed for research is a huge step towards its advancement. It signals the growing federal realization that psychedelic therapies may hold promise in the treatment of several health conditions and that the barriers to the development of these treatments could be removed in the future.

The FDA, under the Trump administration or another future administration, might choose to rely on real-world evidence, such as the recent pre-clinical evidence from England and Canada, as a basis for granting “breakthrough therapy” designations for psychedelic-assisted treatments, potentially accelerating the development and review of these treatments.

Several foreign governments have already reframed drug regulatory frameworks to expand psychedelic research. The DEA now acknowledges that more DMT is needed for research. If more breakthrough designations are issued to psychedelics like DMT, Americans suffering from debilitating conditions might gain access to these treatments in the future.

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However, psychedelic drugs have unique characteristics that challenge the feasibility of double-blind placebo trials. Psychedelic trials often face “functional unblinding,” where participants can easily identify whether they are receiving the active treatment due to the intense perceptual and emotional effects induced by these substances. Given this limitation, the U.S. Food and Drug Administration (FDA) should reconsider double-blind placebo requirements for psychedelic clinical investigations.

As the therapeutic potential of psychedelics gains increasing recognition—particularly for neurodegenerative disorders and mental health conditions like depression, anxiety, and post-traumatic stress disorder (PTSD)—the FDA must consider alternative trial designs. Future administrations should review other possible methods that will uphold safety and efficacy standards while addressing the unique challenges posed by psychedelics.

None of this should be taken to downplay the problem when trial participants can tell whether they’ve received the active drug or a placebo. Functional unblinding can introduce significant bias, particularly in outcomes relying on self-reported measures of mental health or well-being. Participants aware of their treatment status may report exaggerated benefits due to expectancy effects, while those in the placebo group may experience disappointment or a “nocebo” effect when symptoms worsen because participants are aware they did not get the treatment.

The FDA recently rejected MDMA-assisted therapy for PTSD due to problems with this functional unblinding, despite robust clinical evidence supporting its efficacy. Clinical data collected during two nearly identical randomized trials demonstrated MDMA’s effectiveness in improving PTSD symptoms. One of those studies showed that 67% of participants in the MDMA treatment arm no longer met the diagnostic criteria for PTSD following three dosing sessions with MDMA, compared to about 32% in the placebo group who underwent the therapy sessions but did not receive an active drug.

Berra Yazar-Klosinski, Chief Scientific Officer at Lykos Therapeutics, emphasized the strength of the findings, stating, “In totality, these results support [that] MDMA in combination with psychological intervention provides significant and meaningful reductions in PTSD symptoms and functional impairment in patients with PTSD.” If approved, MDMA would represent the first new PTSD treatment in decades and a major milestone for the broader movement to expand access to psychedelics.

However, FDA staff raised concerns that functional unblinding may have inflated the results. “Although we do have two positive studies, the results are in the context of dramatic functional unblinding,” noted Dr. David Millis, an FDA clinical reviewer. These concerns were central to the FDA’s decision to reject the sponsor’s new drug application for MDMA as a PTSD treatment.

Psychedelic drugs will continue to be rejected if double-blind placebo trials are required. But there are other options.

Innovative alternative approaches to psychedelic trials

Alternative trial designs, such as using mimetic psychoactive placebos (which mimic aspects of the drug) or open-label trials, recognize the distinct nature of psychedelics and ensure that promising therapies can meet regulatory standards. 

Instead of inert placebos, trials could use psychoactive substances, such as low doses of cannabis, ketamine, or anxiolytic drugs like benzodiazepines, that mimic some aspects of the psychedelic experience without triggering full perceptual disturbances. Substances that produce mild euphoria, relaxation, or slight perceptual changes could be used to simulate the sensory alterations associated with psychedelics without prompting transformative or profound subjective experiences.

Using mimetic psychoactive placebos would reduce the likelihood of functional unblinding. If participants in both the experimental and control groups experience similar side effects or mild psychoactive sensations, it becomes significantly harder for them to discern whether they are receiving the active drug or the placebo.

Moreover, the unique effects of the experimental drug may be isolated better when its therapeutic effects are compared to those of a psychoactive placebo. For instance, comparing the adverse effect profiles of a psychedelic drug and a mildly psychoactive control can provide more nuanced safety data. Researchers can distinguish common side effects of psychoactive substances—such as mild nausea, dizziness, or euphoria—from those unique to the drug under investigation. Such comparisons can inform risk assessments and improve the design of future trials, ensuring both participant safety and the reliability of the data.

One potential concern is that participants may develop hypotheses about their group allocation based on subtle differences in effects. Rigorous training for study personnel and carefully designed scripts can help mitigate this risk.

Another alternative to double-blind placebo trials is allowing trials to investigate low, medium, and high doses of the psychedelic drug without including a placebo group. Researchers could easily examine dose-response data without exposing participants to the nocebo effect. However, having a non-active placebo allows for better safety evaluation.

Placebo-controlled trials, despite functional unblinding risks, remain valuable for better safety signal identification. A safety signal is information on a new or unknown adverse event that is potentially caused by a medicine and that warrants further investigation. Combining different trial designs can analyze dose-response information from placebo-free trials and safety and efficacy contextualization (safety and effectiveness interpretation through data from various trial designs to assess benefits and risks comprehensively) from placebo-controlled trials. Researchers can explore how varying doses of treatment affect an outcome, focusing on the relationship between dose and therapeutic or adverse events.

One final option is allowing for open-label trials. Open-label trials eliminate the placebo arm entirely by providing all participants with active treatment. Clinical outcomes are compared to pre-existing historical data or external control datasets to evaluate safety and efficacy.

On one hand, this option eliminates ethical concerns of denying treatment to individuals who may have severe mental health or terminal illnesses and where withholding treatment may increase suffering. Additionally, open-label trials are relatively cost-effective because blinding procedures and placebo production are unnecessary.

However, without a blinded control group, participant expectations could influence outcomes, making it harder to attribute improvements solely to the treatment. Biased data becomes significantly more likely. Given this, researchers should consider combining open-label trials with a small, blind control arm in early phases to validate assumptions before larger studies.

As an example, in studies evaluating psilocybin for end-of-life anxiety, an open-label approach could provide useful data by comparing treated participants’ outcomes to external datasets of patients receiving standard-of-care therapies, such as counseling or pharmacologic anxiolytics.

Recommendations

Psychedelic drugs have distinctive effects that make their clinical investigation unfit for traditional double-blind placebo trials. The Trump administration (and future administrations) should consider the following recommendations:

Recommendation #1: Implement alternative trial designs     

Functional unblinding compromises data validity. Placebo-induced nocebo effects exacerbate ethical challenges inherent in double-blind placebo trials. Alternative trial designs, including mimetic placebos, dose-response studies, and open-label trials with historical controls, offer effective ways to generate robust safety and efficacy data while addressing the limitations of double-blind placebo trials.

Future administrations should issue tailored guidance that recognizes the distinctive characteristics of psychedelics and the limitations of traditional double-blind placebo designs.

In doing so, regulators can minimize harm to participants and accelerate the development and delivery of promising therapies. Future administrations should aim to align research goals with patient welfare. Such reforms will facilitate timely access to transformative therapies for those in need.

Recommendation #1.2: Establish safety and monitoring criteria specific to psychedelics for alternative trial designs      

Future administrations should consider and identify specific safety protocols and standards for alternative trial designs to ensure consistency and validity of data outcomes.

The FDA should recommend training programs for trial investigators and session monitors to ensure consistent and accurate reporting of abuse-related adverse events and other safety signals specific to psychedelics. Administration should encourage sponsors to engage in early discussions about trial designs and adverse event monitoring plans, particularly for abuse-related effects. This collaboration can streamline the approval process by resolving potential concerns before studies begin.

The FDA should specify criteria for selecting and validating active placebos, including their safety, tolerability, and appropriateness for mimicking non-therapeutic aspects of psychedelic drugs. Such criteria ensure consistency and reliability across studies.

The FDA may consider nuanced safety analyses, such as comparing adverse event profiles across active treatments and controls, to differentiate between common psychoactive effects and those unique to psychedelics. This will enable more accurate risk-benefit assessments.

Recommendation #2: Use real-world evidence (RWE) to evaluate post-market drug safety and efficacy

Real-world data (RWD) and real-world evidence (RWE) could ensure access to promising psychedelic treatments while upholding rigorous safety and efficacy standards.

The FDA currently leverages RWE to monitor and evaluate the post-market safety of approved drugs and is increasingly recognizing its potential to inform regulatory decisions, including drug approvals and post-approval studies. However, a future administration should broaden the use of RWE so that it can also be used in pre-market evaluations. Existing historical and international evidence offers valuable data on the real-world benefits and risks of psychedelic treatments.

RWD refers to information related to patient health status and the delivery of health care that is routinely collected from various sources. These include electronic health records (EHRs), medical claims data, product or disease registries, and data from digital health technologies. Meanwhile, RWE is made up of the clinical insights derived from analyzing RWD. It provides information about the use, potential benefits, and risks of medical products outside the controlled environment of clinical trials.

There is already a significant amount of RWE on psychedelics. Psychedelic substances have a long history of use, with evidence indicating their application in traditional medicinal and spiritual practices for thousands of years. For example, the peyote cactus was used as early as 14,000 BCE in present-day Mexico, and psilocybin mushrooms were integral to spiritual and healing practices in Indigenous cultures like the Ojibwa of the Great Lakes region.

Moreover, several countries have integrated psychedelics into clinical settings for pharmaceutical purposes. In 2023, Australia authorized psychiatrists to prescribe MDMA and psilocybin for treatment-resistant depression and PTSD within controlled clinical environments. Since 2014, Geneva University Hospital has offered Swiss patients psychedelic-assisted therapy for compassionate use in last-resort cases. The Swiss Federal Office of Public Health has issued over 1,000 exceptional permits to around 60 therapists, facilitating an estimated 2,000-3,000 treatments with psychedelics like MDMA, LSD, and psilocybin. Last year, the Canadian government announced a substantial investment of nearly $3 million to support clinical trials examining psilocybin-assisted psychotherapy.

A future administration could use historical and modern international evidence to expand its use of RWE to pre-market evaluations for psychedelic therapies. The centuries-long ceremonial and medicinal applications of psychedelic substances could provide a robust foundation of observational evidence on their safety and efficacy. Meanwhile, RWE from countries such as Australia, Canada, and Switzerland—where psychedelics are already being integrated into therapeutic and clinical frameworks—could be implemented into regulatory decisions. Broadening the use of RWE to pre-market evaluation could streamline access to innovative treatments while ensuring proper safety and efficacy standards.

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Neurodegenerative disorders, such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), affect millions of people, and no current treatments can effectively stop or reverse disease progression. As these diseases worsen over time and become increasingly more prevalent, they place a growing financial burden on patients, families, and healthcare systems. Current treatments are falling short, and millions of people continue to suffer, underscoring a need for innovative treatments.

Recent research suggests that psychedelics, such as psilocybin and LSD, show strong potential as effective treatments for neurodegenerative disorders. Unlike traditional medications that mainly manage symptoms, psychedelics may offer a pathway to disease modification through mechanisms like enhanced neuroplasticity (the brain’s ability to adapt and reorganize itself), reduction of neuroinflammation, and promotion of cellular regeneration. These effects could be crucial in counteracting underlying disease causes, such as neuron loss and cognitive decline.

Psychedelics have also shown strong potential in treating depression and anxiety, both in terminal illness and potentially in neurodegenerative disorders. Given that neuropsychiatric symptoms are prevalent in AD and worsen the disease’s course, these findings are significant. Although the preliminary results are promising, the small sample sizes, short duration, and the use of healthy or non-AD populations limit the generalizability of these findings to AD. Larger, long-term trials specifically involving AD patients are needed to establish safety, efficacy, and optimal dosing strategies.

Regulated psychedelic-assisted therapy (PAT) centers represent a pivotal opportunity in the development of psychedelic treatments. These centers create a controlled and structured environment for administering psychedelic therapies under clinical supervision. PAT centers allow for both therapeutic practices and rigorous data collection to occur, ensuring that the treatment protocols are consistently monitored and evaluated.

Data gathered from these centers can provide early evidence of the safety and efficacy of psychedelic substances in a therapeutic setting, crucial for addressing regulatory and medical concerns. Insights gained from this early-stage data can accelerate the integration of psychedelics into standard treatment regimens, laying the groundwork for larger and more extensive clinical trials.

The U.S. Food and Drug Administration (FDA) has previously recognized the potential of psychedelics, granting “breakthrough therapy” designations to treatments incorporating substances like psilocybin, MDMA, and LSD for treating various mental health conditions. This designation is designed to expedite the development and review of therapies that may offer significant improvements over existing treatments and could similarly be sought for psychedelic treatments aimed at neurodegenerative diseases.

Implementation of regulated PAT centers could generate early data that may help certain psychedelics achieve breakthrough therapy designation for neurodegenerative disorders. Breakthrough designation will help bridge the gap between early-stage research and large-scale clinical adoption, accelerating the availability of these treatments for patients in need.

Full Policy Brief: Psychedelic Treatment for Neurodegenerative Disorders

The post Psychedelic treatment for neurodegenerative disorders appeared first on Reason Foundation.

Alzheimer’s disease is relentless and incurable. In 2020 and 2021, Alzheimer’s was the seventh-leading cause of death in the U.S. Today, nearly 6.9 million Americans aged 65 and older suffer from Alzheimer’s, facing a progressive decline that current treatments cannot stop or reverse. If breakthroughs in treatment or cures remain out of reach, the number of people affected is expected to double, reaching a staggering 13.8 million by 2060.

The financial burdens Alzheimer’s imposes are immense. In 2021, Alzheimer’s and other related dementias cost the United States around $607 billion (adjusted to 2020 USD). About $257 billion was attributed to informal (unpaid) caregiving. In 2023, more than 11 million Americans provided an estimated 18.4 billion hours of unpaid support, valued at about $347 billion.

Unfortunately, current treatments are ineffective at mitigating these costs because they fail to address the underlying causes of Alzheimer’s. At best, they provide only temporary symptom relief. Worse, they come with a considerable risk of adverse effects and declining quality of life, and further rising costs.

Psychedelics, particularly psilocybin and LSD, show promise as a new approach to treating Alzheimer’s by addressing one of its primary drivers: chronic brain inflammation. Studies suggest these substances could reduce harmful inflammation in the brain, helping to create a healthier environment for brain cells to survive and function. Psychedelics appear to calm overactive immune cells in the brain, which in Alzheimer’s can cause permanent cell damage. This anti-inflammatory action may help preserve cognitive function and slow the disease’s advancement.

Additionally, psychedelics have shown an ability to stimulate the brain’s natural flexibility, or neuroplasticity (the brain’s ability to adapt and reorganize itself). Psychedelics may increase brain cell communication, a change that may have lasting effects in preserving mental clarity and cognitive function.

Integrating psychedelics into standard care practices could provide real relief, as they target the underlying causes associated with Alzheimer’s. However, it’s equally important that psychedelic therapy is implemented in a safe and effective way. State-regulated psychedelic-assisted therapy (PAT) provides a structured, controlled environment where treatments can be administered under clinical supervision. These types of clinics, which already exist in Oregon and Colorado, allow for delivery of therapeutic practices and detailed data collection, ensuring consistent monitoring and evaluation of treatment protocols.

Data from state-regulated PAT centers can offer insights into the safety and effectiveness of psychedelics, helping to address regulatory and medical questions early on. These findings could speed up the process of integrating psychedelics into mainstream treatments and lay the groundwork for larger clinical trials.

The U.S. Food and Drug Administration (FDA) has already acknowledged the promise of psychedelics, awarding “breakthrough therapy” status to treatments involving substances like psilocybin and LSD for certain mental health conditions. The FDA might also award this designation to psychedelic treatments for Alzheimer’s and thereby accelerate the pathway to full approval of these therapies. By generating reliable early data, state-regulated PAT centers could bridge the gap between early research and widespread clinical adoption while making these novel treatments accessible to patients sooner.

There’s a clear need for therapies that slow disease progression, reduce long-term care requirements, and alleviate burdens on families, caregivers, and society. State legalization and regulation of psychedelic-assisted therapies could facilitate early data collection and yield a transformative shift in Alzheimer’s disease treatment. More states should embrace these options. With continued exploration, psychedelics may pave the way for a more effective, compassionate approach to Alzheimer’s.

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States with legalized recreational marijuana all launched markets with a requirement that commercial licensees track the location of every marijuana plant or package containing marijuana products using seed-to-sale tracking software. Licensees would be responsible for affixing a unique radio-frequency identification tag to every plant or package and entering any changes to that unit of inventory into an online software program to which state regulators would have access.

While this type of system theoretically helps regulators monitor commercial marijuana activity, the granularity of these requirements imposes steep labor costs on commercial licensees that impede the ability of legal suppliers to compete on price with illicit competitors. Reason Foundation proposed in 2019 that states begin tracking inventory on a batch basis rather than on an individual product basis, and now states are beginning to implement that approach.

Maine has just introduced Flexible Standardized Batch Tracking (FSBT). Marijuana plants that are genetically identical, grown in the same location, and treated simultaneously with uniform dosing of nutrients or other permissible chemicals should be able to be tracked as a group. This change eases the tagging and data-entry requirements for licensees, which is an otherwise inefficient and labor-intensive task.

In many states that have legalized cannabis, each plant must be weighed individually upon harvest and after drying, and those weights must be manually recorded into a software application. This granularity of data arguably provides regulators with no more meaningful information about the disposition of inventory than could be gleaned by weighing a group of 25 or 50 plants together. Maine’s new FSBT system allows homogenous plants to be tracked in groups of 5, 10, 25, or 50.

The inefficiencies created by granular tracking systems have often gone for naught when regulators fail to even make use of the resulting data. In theory, regulators can run forensic data tools on the inventory-tracking database to ensure recorded shipments of marijuana match receipts and look for other signs of potential diversion of inventory to the illicit market. However, regulators have failed to perform these analyses in some high-profile cases.

California regulators were sued in 2021 under allegations that licensed distributors were purchasing legal marijuana from cultivators and then selling it to illicit interstate traffickers. A key point among the lawsuit’s allegations was that regulators were collecting data about the amount of marijuana legally cultivated and wholesaled to distributors but failing to match those totals among the quantities that distributors subsequently sold to licensed dispensaries. A California Superior Court found the plaintiff did not have standing to challenge the manner in which regulators chose to enforce compliance, but the state’s Fourth Appellate District overturned that opinion, and the case is awaiting a new trial date.

California isn’t the only state that has failed to capitalize on highly granular data that is expensive for licensees to generate. Washington legalized recreational marijuana in 2012, but over a decade later, its tracking system still doesn’t work. The current system, the Cannabis Central Reporting System, is riddled with data errors. When licensees are required to complete voluminous data entry every day, they are prone to make errors, and these errors make the database worthless if the software doesn’t have adequate safety protocols to identify potential mistakes.

For example, Washington’s system indicates there were $7.7 billion in total marijuana sales in 2022—five times the amount ($1.3 billion) the state’s Department of Revenue reported. The errors were due to misplaced decimals in reported sales prices, missing records, and incorrect entry of transaction dates. These shortcomings open the door to illegal trade and undermine public trust in the legal market.

Given that so many states have struggled to correctly implement tracking software or failed to capitalize on the resulting database, there is a clear argument for simplifying these programs through batch tracking. In Maine, where craft growers dominate the market, nearly 80% of harvests are less than 50 plants, and about 57% of harvests contain 25 plants or fewer, so batch tracking addresses the needs of most Maine cultivators.

In addition to labor-cost savings from data entry, licensees will bear fewer direct costs of purchasing radio frequency identification (RFID)tags from the approved state vendor. RFID tags are unique for every inventory item to which they are affixed and cannot be reused, so the savings can be substantial. Using fewer tags also generates less plastic waste.

Without accurate data, regulators can’t stop illegal activity or ensure consumer safety, while businesses waste resources attempting to comply with a system that doesn’t work. One of the biggest benefits of FSBT is its adaptability. While growers can use batch tags for efficiency, they still have the option to tag individual plants when needed. This flexibility supports both large-scale producers and smaller artisanal growers, ensuring the system works for everyone.

Maine’s pioneering approach to batch tracking is commendable, and other states that have legalized marijuana should be looking to replicate its approach.

The post Batch-tracking: The next wave of marijuana tracking systems appeared first on Reason Foundation.

Should Florida Amendment 3 pass with at least 60% of the vote, it would decriminalize marijuana possession for adults and allow existing medical marijuana dispensaries to sell non-medical marijuana temporarily until new licensure rules are established. Trulieve, one of Florida’s major existing medical marijuana vendors, is a supporter and one of the major financial contributors trying to get Amendment 3 passed. Trulieve’s involvement has prompted an ad campaign against Amendment 3 that claims that the measure would only benefit “Big Weed” and would not allow others to join the market or grow their own marijuana. Trulieve has filed suit over the ad, calling it “demonstrably false.”

The monopoly fears highlight the crucial role regulations play in creating competitive or monopolistic markets. If Florida lawmakers create a regulatory framework encouraging competition, keeping barriers low, and avoiding burdensome taxes and fees, industry consolidation risks remain minimal. On the other hand, restrictive rules—like limited licenses or excessive costs—could indeed lead to market concentration favoring large companies.

Any market can become monopolized if new competitors are blocked or unable to compete effectively. In government-granted monopolies, the state grants itself or a private intermediary exclusive access to a given market. For instance, some states operate alcohol “monopolies,” where hard liquor can only be legally purchased through state-run stores. In lottery monopolies, only the state or a company contracted by the state may offer lottery ticket sales. But, even when private actors can enter a market, a restrictive regulatory regime can make it nearly impossible for smaller companies to succeed, consolidating power among the largest players.

Poorly constructed regulatory schemes can artificially reduce the competitiveness of a given market, for example, by severely restricting the number of available licenses. This reduces the number of firms competing, ensures only those with the greatest resources or connections can get licensed, and then protects them from prospective new competitors who cannot procure licenses.

Excessive application and licensing fees can have a similar effect when they are prohibitively high for smaller, independent firms. For example, Gov. Ron DeSantis’ administration last year raised the two-year fee for a medical marijuana license from about $60,000 to $1.33 million. It’s rather ironic, then, that Gov. DeSantis is campaigning against the amendment using this monopoly argument when his own administration is responsible for making it harder for competitors to enter the market.

Overly complicated regulatory processes that take months or years can also prevent new or smaller firms from market success. Some marijuana farmers in New York, for example, had to sit on millions of dollars worth of perishable crops they could not sell because the state’s sluggish process for licensing marijuana retailers caused several years of delays. Only the most well-capitalized businesses could bear such costs and uncertainty resulting from this delay, forcing smaller firms to sell their businesses out to larger companies.

Excessive taxes and compliance costs can also make it challenging for companies to succeed, reducing their profits and limiting their ability to set retail prices low enough to attract customers from larger or illicit operators–an issue that California cannabis companies and regulators have struggled for years to resolve.

Fortunately for Floridians, if voters approve Amendment 3, their legislators will have a chance to avoid these mistakes by adopting a framework that promotes a competitive market. Preventing monopolization in Florida’s marijuana market requires focusing on creating accessible and fair conditions for all businesses, regardless of size.

Another important step is to streamline regulations. Heavy-handed rules that only big corporations can afford to navigate stifle innovation and growth among smaller businesses. Instead, regulations should be designed to protect consumers without placing an undue burden on any market participant. For instance, state rules with overly prescriptive testing requirements or that require testing at state-run laboratories can stifle innovation and lead to costly delays that raise the final cost of products. Basing testing requirements on objective third-party standards and allowing testing to be performed by accredited independent laboratories would afford businesses more flexibility and reduce costs.

Expanding market access by encouraging local businesses, small-scale growers, and cooperatives to participate will help prevent the concentration of power in a few hands. Policies that reduce compliance costs and support local ownership can lead to a more resilient and diverse marketplace. A few examples of such policies include making sure there are enough licenses to meet demand, such as offering a separate micro-license for small businesses and low application costs. Policies such as these will help Florida avoid the pitfalls experienced by other states and build a fair and open market for adult-use marijuana.

Monopolies almost never result from open competition but instead due to legal advantages enjoyed by one or more market participants. If Florida’s marijuana market were to operate under similar conditions, where only a few well-connected companies could navigate the complexities of the law, then the fears of monopolization might indeed come true.

The key to preventing monopolies in the marijuana industry is not to limit the market or impose heavy restrictions but to create a regulatory environment that encourages competition and innovation. This means setting clear, fair rules that apply to all market participants while minimizing unnecessary barriers to entry for new businesses.

The argument for regulated markets is not to stifle growth but to ensure that all players—large and small—have an equal opportunity to compete. If voters approve Amendment 3, it will be up to Florida lawmakers to embrace these lessons and safeguard consumers from monopolistic market concentration.

The post No, Florida’s marijuana measure won’t create a cannabis monopoly—as long as lawmakers don’t screw it up appeared first on Reason Foundation.

In many states, the possession of marijuana is now permitted, but it remains illegal under the federal Controlled Substances Act. The federal Gun Control Act of 1968 also prohibits people who have unlawfully used controlled or scheduled substances from possessing firearms. Courts have been divided over whether a marijuana user complying with state law should be considered an “unlawful” drug user for federal firearm regulation.

Even if the federal Drug Enforcement Agency (DEA) moves marijuana from Schedule I to Schedule III in the Controlled Substances Act, as it seems poised to do, any user without a valid prescription could be considered an “unlawful” user by federal standards. Even state-registered medical marijuana patients may not be clear because prescriptions are also federally regulated.

There is no clear evidence that medical marijuana patients are any more disposed to engage in violent crime than other groups. On the contrary, the available evidence indicates that medical marijuana is associated with slightly lower crime rates.

While this issue continues to be debated in federal courts, many lawmakers at the state and federal levels have proposed legislation to resolve this apparent conflict. Several states have considered legislation that would either conform state firearm regulation to federal standards or instead protect a state-legal marijuana user’s right to own a firearm under state law.

Let’s explore the evolution of federal laws involving gun ownership for individuals using marijuana legally under state laws, and discuss recent efforts by state legislators to address and reconcile discrepancies between state and federal regulations.

Who is an “unlawful” marijuana user?

Federal courts have reached inconsistent conclusions about whether a person who uses marijuana following state law should be allowed to purchase or possess a firearm.

Federal courts’ understanding of the Second Amendment needed to adapt to the U.S. Supreme Court’s 2022 decision in New York State Rifle & Pistol Association Inc.  v. Bruen. The plaintiffs in Bruen, the New York State Rifle & Pistol Association and two individuals, challenged New York’s requirement that applicants demonstrate “proper cause” to obtain a concealed carry license.

In a 6-3 opinion written by Justice Clarence Thomas, the Supreme Court ruled that this requirement was unconstitutional, concluding that the Second Amendment protects an individual’s right to carry a handgun for self-defense outside the home. The majority decided that regulations on the right to bear arms should be consistent with the nation’s historical traditions.

This Supreme Cout decision has led to new questions about whether barring marijuana users from purchasing or possessing firearms is consistent with historical American approaches to firearm regulation. In at least one case, a federal district court has ruled that this ban is inconsistent with the standard set in Bruen.

In 2022, Oklahoma resident Jared Harrison was charged with unlawful possession of a firearm after an officer of the Lawton Police Department found marijuana and a handgun in his car. Judge Patrick Wyrick of the U.S. District Court for the Western District of Oklahoma dismissed the indictment, ruling that the federal statute banning “unlawful” users of cannabis from possessing firearms violated the Second Amendment. Wyrick emphasized that marijuana use lacks the consequences (like violent behavior) historically used to justify firearms regulation, stating that “mere use of marijuana does not indicate that someone is in fact dangerous, let alone analogous to a ‘dangerous lunatic.’”

In the case of United States vs. Daniels, a Mississippi resident, Patrick Daniels, was convicted of possessing a firearm after he was deemed an “unlawful user” of marijuana in 2022. Daniels admitted to smoking marijuana multiple days per month, leading to his conviction. However, the government did not provide evidence of his intoxication at the time of arrest or specify when he last used marijuana.

The Daniels case touches both the broad question over whether his conviction aligns with the historical tradition of firearm regulation in the United States, as well as the narrower issue of whether a person must be actively impaired for the prohibition to apply.

The Fifth Circuit Court overturned Daniels’ conviction in August 2023, arguing that disarming a sober citizen solely based on past drug use lacks historical precedent in American jurisprudence. More broadly, the court concluded, “… [M]ore generalized traditions of disarming dangerous persons [do not] support this restriction on nonviolent drug users.”

In other words, the Fifth Circuit concluded both that the government could not restrict gun ownership for marijuana users during periods of sobriety and that the government could not restrict gun ownership for marijuana users at all.

A fourth case decided before the Supreme Court’s decision in Bruen adds to the legal complexity: While individuals with medical marijuana cards are prohibited from purchasing firearms under federal regulations, those who already possess firearms are still able to obtain a state medical marijuana card.

In Wilson v. Lynch (2016), S. Rowan Wilson was denied the purchase of a firearm by a Nevada gun dealer because she held a state-issued medical marijuana card. This rejection came after a 2011 letter from the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) directed gun dealers to consider medical marijuana cardholders as unlawful users of a controlled substance. Wilson filed a lawsuit alleging that the ATF rule violated her First, Second, and Fifth Amendment rights. The lower courts dismissed her case twice, and on her second appeal, the Ninth Circuit affirmed the lower court’s dismissal.

The court contended that under federal law, marijuana is a Schedule I controlled substance, and users are prohibited from purchasing firearms due to the increased likelihood of violence associated with drug use.

Wilson argued that she did not use marijuana but held the card to support the political cause of legalization. Wilson’s argument was rejected, as the court deemed the restriction on firearm purchases did not impede her ability to advocate for marijuana legalization through other means. Her Fifth Amendment claim also failed, as the court ruled there is no constitutional right to hold a medical marijuana card and also purchase a gun. The court concluded that Wilson could either forfeit her card to buy a firearm or keep her card and forgo new firearm purchases, prioritizing the federal government’s interest in regulating firearm sales over her individual rights in this context.

The same fight occurred in the U.S. District Court for the Northern District of Florida, where the Florida Department of Agriculture and Consumer Services commissioner and three Florida residents filed suit in April 2022. In the case Fried et al. v. Garland et al., pending in the U.S. District Court for the Northern District of Florida, plaintiffs challenged whether medical marijuana use under state law should prevent individuals from exercising their Second Amendment rights.

The U.S. Department of Justice has filed a motion to dismiss, arguing that medical marijuana patients are too dangerous to own firearms, citing concerns about public safety.

The two plaintiffs are registered medical marijuana patients and are barred from purchasing a firearm. One plaintiff owns a firearm and would like to use marijuana for medical reasons. Will Hall, an attorney with the Dean, Mead & Dunbar firm representing the plaintiffs, told The News Service of Florida that the Supreme Court ruling puts the onus on Garland’s office to justify the gun denial.

Last year, before the U.S. Court of Appeals for the Eleventh Circuit panel, Hall argued that banning people who use medical cannabis from owning guns is inconsistent with historical firearm regulations and the original context of the Second Amendment. The Department of Justice (DOJ) argued in response that early laws restricting gun rights over drunkenness and mental illness provide a historical basis for the ban.

“Our reading of the case is [that] the federal government has to show that this regulation, which is basically treating medical marijuana patients as if they are just, per se, too violent to possess guns, has some kind of historical tradition, and we just don’t see it,” Hall said.

Hall said Fried’s legal team scoured the issue to see if there was “any equivalent regulation” in the distant past, but they couldn’t find any. “There’s really no equivalent for what we have in medical marijuana now, which is that the states have made it legal and the federal government has, not just through a letter or some promise but through law, said we will protect those programs from interference.”

Although an opinion hasn’t yet been delivered, during oral arguments the judges questioned the DOJ’s classification of these state-registered medical cannabis patients as not law-abiding.

States considering legislation to allow firearm possession by marijuana users

In 2024, several states introduced bills that directly challenge the DOJ’s position, though, as with drug legalization, states cannot stop the federal government from continuing to enforce its ban.

In Minnesota, where adult-use marijuana is legal, state legislators introduced companion bills House File 657 and Senate File 89. According to the Minnesota legislation, a patient enrolled in the medical cannabis registry will not be considered an “unlawful user” of a controlled substance under state law. Participation in the medical cannabis registry does not disqualify individuals from possessing firearms and ammunition.

The bills specify that a sheriff cannot deny a permit to carry solely based on the applicant’s enrollment in the medical cannabis registry or use of medical cannabis for a qualifying condition. Further, any state paperwork used to approve or disapprove a person’s eligibility to purchase, own, possess, or carry a firearm must allow qualifying patients to refrain from reporting their use of medical cannabis.

However, the bill adds that individuals enrolled as patients in the medical cannabis registry who use medical cannabis and know or have reason to know that it can cause impairment will still be prohibited from carrying a pistol in a public place.

A Maryland House committee heard testimony on House Bill 0296, which seeks to ensure that registered medical marijuana patients in Maryland can purchase, own, and carry firearms, regardless of their cannabis use.

Testimony during the hearing on Maryland’s bill largely featured veterans and advocates, including Army veteran Randall Cody Floyd, who emphasized the disparity between firearms policies for medical cannabis users and those using prescription opioids. Floyd stated, “Basically I chose my medical cannabis card over my gun rights, and I should not have to do that. I can get my carry permit with prescription opioids or painkillers, but for something that I choose that’s a less harmful route, I can’t own a gun. Why is that?”

Mark Pennak, president of Maryland Shall Issue, a gun rights advocacy group, cautioned that even if H.B. 0296 passes, federal law still criminalizes cannabis users’ firearm ownership, exposing them to arrest and potential felony charges. Gun dealers may also refuse sales to individuals acknowledging marijuana use, regardless of state law.

The companion legislation, Senate Bill 0348, passed the Maryland Senate with strong bipartisan support. If enacted, the law would take effect on October 1.

In Kentucky, where marijuana use is permitted solely for medical purposes, lawmakers proposed Senate Concurrent Resolution 44, urging the United States Congress to “repeal federal restrictions that prohibit the possession and use of firearms by individuals who use marijuana in compliance with state or tribal laws.”

States seeking to conform to federal law

On the other hand, some lawmakers have worked to align their states with the federal ban, introducing bills that ensure medical marijuana users will not be permitted the right to bear arms unless marijuana is federally legalized.

South Dakota and West Virginia both introduced bills that, if passed, would require that each application for a medical marijuana registry identification card and renewal card include a notice that informs medical marijuana applicants that “[U]ntil marijuana is legalized under federal law, an individual who is a current user of marijuana is, under federal law, an unlawful user of a controlled substance; and, Federal law does not exempt the use of marijuana for medicinal purposes.”

South Carolina lawmakers also affirmed these federal gun restrictions in proposed legislation to authorize a medical marijuana market. That bill, H. 346, passed the state Senate this spring but stalled in the House. This legislation was carried over from prior sessions and is likely to be reintroduced again next year. If eventually passed, medical marijuana patients will receive a flier notifying them of their inability to possess a firearm. Additionally, legislators will require a statement signed by qualifying medical cannabis applicants declaring that the individual is not employed in, or contracted to perform, any job in which the person will carry a weapon, including a firearm.

Elsewhere, Idaho legislators introduced a bill that explicitly states, “a license to carry concealed weapons shall not be issued to any person who is an unlawful user of marijuana.” Idaho is one of only five states that prohibits the use of marijuana of any kind, including for medicinal purposes.

Federal bills

There have also been attempts in the U.S. Congress to alter the federal approach to firearm regulation for marijuana users, particularly for veterans.

Last year, Rep. Alex Mooney (R-W.V.) introduced House Resolution 363: The Second Amendment Protection Act, while Rep. Brian Mast (R-Fla.) introduced House Resolution 2772: The Gun Rights and Marijuana (GRAM) Act. Both seek to remove federal firearms-related restrictions for individuals who live in a state or on lands where adult marijuana use is legal under state or tribal law, given that an individual’s marijuana use does not violate state or tribal laws.

Rep. Mast stated, “Addressing this issue is of particular importance to the veteran community,” adding, “No veteran that I know wants to be forced to choose between a viable treatment option for conditions like PTSD, and the ability to protect themselves and their families. The GRAM Act is about ensuring no one has to make that choice.”

Both bills were referred to the House Committee on the Judiciary and have not seen further progress. However, it is not uncommon for legislation addressing issues like cannabis and firearms to face hurdles in the legislative process.

Conclusion

Federal case law around the Second Amendment has generally prohibited the possession of a firearm by a person who is considered a risk to themselves or others, as well as by a person convicted of committing or threatening a violent crime.

Many states are recognizing that marijuana is safe to consume with minimal abuse risk. The mere use of marijuana does not indicate that someone is dangerous or suffering a mental health condition that would inhibit them from gun ownership.

There is no clear basis for restricting an individual’s right to possess a firearm due to marijuana consumption, particularly in light of the Supreme Court’s new standard that firearm regulation remains consistent with historical precedent. Alcohol users do not confront a blanket prohibition against firearm ownership; they are barred from carrying a firearm while actively intoxicated. A similar standard should be applied to marijuana users, and this standard should be consistent at the state and federal levels.

The post Examining court rulings and state and federal laws on marijuana users’ gun rights appeared first on Reason Foundation.

Reason Foundation recognizes and appreciates the rigor and diligence with which the Colorado Department of Regulatory Agencies (DORA), advisors, and stakeholders have worked to build the operating regulatory framework for The Natural Medicine Health Act.

The process overall appears to have generated a prudent set of rules that balances client safety with strong licensee oversight. As a first-in-the-nation exercise in developing such a robust framework, DORA’s work is important because both the strengths and shortcomings of its proposed framework are likely to be replicated elsewhere.

In that spirit, Reason Foundation has noted several areas for potential improvement to the draft permanent rules DORA and the Colorado Department of Revenue have proposed:

• 2.2.A.9— “A Facilitator licensee must recommend in writing that any prospective participant who is taking a psychotropic medication identified as a risk factor on the safety screen should obtain applicable medical and behavioral health clearance from a physician (MD) or (DO), an Advanced Nurse Practitioner (APN), a Physician Assistant (PA), or a Clinical Facilitator with prescribing authority prior to administering natural medicine services.” We believe this requirement is both ambiguous and overly restrictive. The Centers for Disease Control in 2020 estimated that roughly 16% of Americans take medications for mental health—and among the population of individuals seeking the therapeutic use of natural medicines this ratio may be higher. There is no clear definition of “psychotropic” nor is there public health consensus on whether the most common antidepressants, such as escitalopram, are contraindicated. Indeed, one recent report by Atai Life Sciences clinical studies shows that concurrent antidepressant use with psilocybin is safe. We applaud the requirement of facilitators to develop a safety plan for potentially contraindicated psychotropic substances and affording facilitators the option not to work with a patient.
• 2.8.C — “Following completion of didactic educational requirements, training licensees must complete 40 hours of supervised practicum.” Unnecessarily long training requirements and other supervised requirements for students in training will dramatically increase costs for consumers. Practicum hours could be completed concurrently with didactic training or through the proposed “training” license where students can serve clients while acting under the supervision of an approved supervisor. The proposed practicum training requirement already exceeds the requirements for a psilocybin facilitator license in Oregon by 25%, and there is no evidence that more instructional hours will affect client safety. We propose reducing all didactic module requirements hours by 50% and replacing these didactic modules with supervised practicum hours with financial remuneration permissible for the trainee.
• 2.4.A.1 — “Applicants who are former legacy healers, and who do not hold a license or other credential to practice facilitation, may apply for licensure through an accelerated training pathway. In addition to the general requirements for licensure set forth in Rule 2.1, all applicants must demonstrate that 1. The applicant has substantially equivalent education, experience, or credentials…” Rules for legacy healers are both ambiguous and potentially incriminating. These rules offer no precision on how regulators will assess equivalency between legacy experience and approved education requirements. Additionally, providing documentation of experience may require healers to admit illicit activity. This rule needs explicit examples and standards for equivalency and for the ability to attain legacy status without providing proof of illicit activity.
• 2.5.C.1.a—- Rather than list which providers may concurrently use natural medicines with their existing state health license, the regulations should allow any state-licensed healthcare professionals to administer natural medicines within the scope already set by the state. Otherwise, regulators may inadvertently exclude practitioners, such as naturopathic doctors, from serving their clients.
• 4.1.E.4.b— Training programs should not require two faculty members. Small businesses should be permitted to operate with one part-time member so long as they meet other quality standards.
• 3105 — Colocation of multiple licenses and service options is a welcome addition that may reduce costs and allow ecosystems of complementary business types to materialize.
• 3115.B — There’s no specification of minimum resolution for video surveillance equipment. Licensees may not know how to remain in compliance if a minimum resolution is not specified.
• Secs. 3115 and 3120 — These rules do not establish nor define any central inventory tracking system similar to the electronic tracking systems used to monitor licensed cannabis inventory. The proposed regulations should either authorize the department to contract with the provider of a centralized inventory tracking system or should specify parameters that licensee inventory tracking systems must include. (In particular, recalls are aided by a central tracking system).
• 3405.B — Allow transportation directly to consumers so that facilitators can potentially avoid violating IRS 208(e), threatening their ability to claim tax deductions. IRS section 208(e) prohibits businesses engaged in trafficking of a Schedule 1 substance from claiming business deductions. While there is little legal precedent for psychedelic therapy, facilitators might credibly claim that if they only provide services to clients who already purchased psilocybin, their business would not violate 208(e). Allowing direct sales to consumers within a healing center could open up important cost savings.
• 4 CCR 755-1 8.3.B — “If it appears to the Director that a person without a license is engaged in the provision of facilitation, i.e., the performance and supervision of natural medicine services for a participant, the Director may issue an order to cease and desist,” This section is unclear as to what constitutes “facilitation.” Under SB 290, persons may conduct paid “harm reduction” services concurrently with clients ingesting natural medicines and this service may be substantially similar to religious, ceremonial, or therapeutic experiences. This section needs to more clearly define what constitutes “facilitation” and how it is distinct from protected harm reduction or ceremonial practices that may include commercial services and financial remuneration.
• 8.1.B.5 — This section would unfairly penalize someone who “habitually” uses a controlled substance, even when their use is otherwise non-problematic. For instance, this could discipline licensees for non-abusive substance use, such as weekly cannabis use as a sleep aid or microdosing psilocybin for anxiety.
• 6.17.G — There is no scientific basis for limiting the ratio of group experiences to a maximum of one facilitator per four clients. Group facilitation is one of the most important approaches to reduce cost and increase accessibility. Facilitators should be able to hire unlicensed staff to help clients throughout the experience—for instance, if a client needs to use the restroom. We recommend no formal ratio limits of facilitators-to-client until there is evidence of a need. If a ratio must exist, it should allow unlicensed guides to count toward the staff-to-client ratio.

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When Alaska voters approved an adult-use recreational market for marijuana in 2014, the initiative they approved included a wholesale excise tax of $50 per ounce, or $800 per pound, which places Alaska among the highest taxed states for legal marijuana. As originally proposed, HB 119 would have reduced this tax rate by 75%, down to $12.50 per ounce and imposed a new 3% retail sales tax on marijuana products. An amendment adopted on the House floor prior to passage increased the proposed retail sales tax to 7%.

The amended bill garnered overwhelming support in the House, passing with a vote of 36-3, and has been assigned to the Senate Finance Committee. The legislation reflects the recommendations of a task force convened by Gov. Mike Dunleavy in 2022 to study the state of the industry and recommend improvements. Brandon Emmett, a task force member who works in the industry, told the House Labor and Commerce Committee:

I can tell you with a high degree of certainty that [marijuana] is still much cheaper on the black market. Alaska’s taxes and the burden on businesses from the Marijuana Control Board is causing prices to stay high and businesses to be uncompetitive.

Emmett went on the say he believes 40 to 50 percent of marijuana sold in Alaska is from unlicensed vendors because the illicit market offers better prices.

A legislative aide also told committee members that marijuana tax revenue is declining in Alaska and that lower tax rates could eventually result in greater tax revenue as a greater proportion of transactions migrate to the legal market in response to lower prices and become subject to taxation.

These observations highlight two common, but conflicting, goals of marijuana legalization. Legalization advocates aim to displace an unregulated and potentially dangerous illicit market with an orderly legal market. Many policymakers are focused instead on generating substantial new tax revenues on legal marijuana sales. To the extent that the cost of taxes and regulations raise the price of legal marijuana goods relative to competing illicit goods, however, consumers and producers may choose to remain in the illicit market, undermining legalization entirely.

A recent large-scale survey published in the Journal of Studies on Alcohol and Drugs of consumers across the United States and Canada found that marijuana users prefer legal products when prices are comparable to those in the illicit market. However, if the price of legal products increases above that of illegal products, consumers tend to revert to the illicit market. Among 50,000 respondents, 17,000 had purchased marijuana in the past year, and 12,000 of these had bought illegal marijuana, citing price as the primary reason.

In 2022, Reason Foundation analyzed the impact of state and local cannabis taxes in California on the decisions of producers and consumers to participate in the legal market. The analysis revealed that the total effective tax per pound of cannabis ranged from $677 to $1,440, depending on the jurisdiction. These taxes exceeded the estimated wholesale production cost of $564 per pound, pushing two-thirds of marijuana transactions in California to the illicit market in 2021, resulting in no tax revenue from these transactions. Our modeling indicated that eliminating California’s statewide cultivation tax would accelerate market growth for legal retailers, increasing transactions subject to retail excise and sales taxes. By December 2024, we projected that cannabis tax revenues would grow to 223% of their March 2022 levels, even without the cultivation tax. California adopted this change, eliminating the cultivation tax in June 2022.

A key lesson is that taxes influence behavior and excessive taxes can lead to reduced revenues by encouraging individuals to avoid the taxed behavior altogether. In the case of marijuana, individuals may simply choose not to buy legal goods.

Reason Foundation acquired proprietary data from market analytics firm New Frontier Data that estimates the size of the legal versus illicit market in Alaska. This data, plotted below, shows that illicit sales in Alaska still account for 62% of the state’s overall marijuana market. Roughly $200 million in illicit sales are forecast to occur in 2024 compared to only $125 million in legal sales.

Alaska has a long way to go for its orderly and legal marijuana market to displace the illicit market. A critical plank in its strategy should be to reduce the tax-induced price disparity between legal and illicit goods. Legislative staff has recognized this reality, affirming testimony submitted by Reason Foundation. It’s encouraging that Dunleavy and House lawmakers have supported the effort to reduce Alaska’s punitive taxes on legal marijuana.

The post Alaska considers much needed reduction in marijuana taxes appeared first on Reason Foundation.

Now, in 2024, several more states are considering the legalization of recreational cannabis, the medicinal use of cannabis, or the decriminalization of marijuana.  

Big action states with proposed bills to legalize recreational cannabis use 

New Hampshire: New Hampshire is the only northeastern state that has not yet legalized and regulated the adult-use marijuana market. The New Hampshire House of Representatives recently passed House Bill 1633 a bipartisan proposal that would license private entities to engage in commercial cannabis activities. That legislation is competing with a proposal backed by Gov. Chris Sununu and state Senate Republicans that would see the state’s liquor commission operate a retail monopoly over adult-use cannabis. 

North Carolina: North Carolina’s House Bill 626 would legalize the possession and sale of cannabis. Its preamble declares, “[C]annabis prohibition, like alcohol prohibition before it, has been a wasteful and destructive failure.”

The bill would authorize an unlimited number of cannabis licenses for qualifying entities and would not allow application fees to exceed $5,000. However, it would levy a relatively high retail excise tax on cannabis products of 30% and would allow local governments to ban any commercial cannabis activity. 

Hawaii: Hawaii came very close to enacting an adult-use market for marijuana earlier this year. After lawmakers debated multiple proposals for legalization the year prior, the Hawaii attorney general’s office hosted a working group with leaders from the legislature during the interim to develop language that might secure a legislative consensus. Reason Foundation consulted with key lawmakers throughout this process and made extensive recommendations on the language contained in the ultimate bill, Senate Bill 3335, and also published an analysis of the existing cannabis market in Hawaii to help inform the debate. This legislation was ultimately voted down in its final committee of jurisdiction, the House Finance Committee, although it advanced farther than any prior legalization proposal in Hawaii. 

Pennsylvania: In Pennsylvania, House Bill 1080 and House Bill 1082 are competing proposals to legalize and regulate cannabis sales for adults aged 21 and older.  Both bills were assigned to the House Health Committee in May 2023 and remain alive but have not received a committee hearing.   

House Bill 1080 would allow individuals aged 21 and above to possess, consume, cultivate, and purchase cannabis from state-operated stores under the management of the Pennsylvania Liquor Control Board. Retail cannabis sales would be subject to a 19 percent tax rate, with all generated revenue directed towards the state general fund. HB 1080 also introduces a specialized regulatory framework for industrial hemp. 

Pennsylvania HB 1082 would create a recreational cannabis market with licenses granted to farmer-growers and grower-processors. It would limit licensing fees to $2,500 and impose only a modest 1% excise tax on the gross receipts of licensees. However, the bill would empower the regulatory authority to impose minimum capitalization requirements for licensure, which can be a significant barrier to entry into the marketplace. 

West Virginia: West Virginia’s Senate Bill 386 and House Bill 4873 would legalize and regulate cannabis for adults. These measures are identical and would allow counties to create a ballot question proposing cannabis legalization within their jurisdiction. If local voters then approve the ballot question, counties could begin to license commercial cannabis entities and charge a 5% excise tax on retail sales. The state would also establish a regulatory structure and issue licenses that cost no more than $5,000 and charge an additional 15% excise tax.

Senate Joint Resolution 8 is an alternative that proposes a statewide ballot question to create a constitutional right for West Virginians to possess up to two ounces of marijuana. None of these proposals has received a committee hearing yet.  

Medium action states introducing bills to legalize medical cannabis 

The first state to effectively legalize medical cannabis was California in 1996 when voters approved Proposition 215. Shortly after, in 2000, Hawaii became the first to legalize medical cannabis through an act of the state legislature. As of today, medical cannabis legalization has spread to more than two-thirds of the states, and more could be poised to join those ranks this year. 

South Carolina: In February, the South Carolina Senate passed Senate Bill 423, which would permit medical marijuana use, mirroring a similar effort in 2022. The 2022 effort failed because that version contained a proposed tax on medical marijuana, and tax bills must originate in the House rather than the Senate. The current version of the bill does not contain a tax but is otherwise highly restrictive. It would not permit home cultivation or smokable marijuana products and would sunset after five years. 

Meanwhile, a separate South Carolina Senate proposal, which has not advanced, proposes an advisory ballot question for the Nov. 2024 general election ballot, allowing voters to weigh in on the legalization of medical marijuana. 

Wisconsin: In Wisconsin, Gov. Tom Evers pushed for full legalization of recreational cannabis going into this legislative session. However, Republican lawmakers have repeatedly rejected calls from Gov. Evers and other Democrats to legalize all uses of marijuana, including medical and recreational.

In response, Gov. Evers conveyed openness to a more limited medical marijuana proposal if it has Republican support. Evers told the Associated Press:

“I would think that getting it all done [marijuana legalization] in one fell swoop would be more thoughtful as far as meeting the needs of Wisconsinites that have asked for it. But if that’s what we can accomplish right now, I’ll be supportive of that.” 

For their part, Assembly Republicans proposed to restrict the sale of medical marijuana solely to state-owned dispensaries. Under the proposal, individuals with qualifying medical conditions could obtain a state-issued medical card to purchase non-smokable marijuana products from only five retail locations across Wisconsin. This limitation, in addition to the prohibition on home cultivation of medical marijuana, would severely restrict patient access and choice. The proposal would also extend the state’s prescription drug monitoring system to the medical marijuana market, adding another layer of regulation and monitoring. 

By contrast, 36 Senate Democrats sponsored legislation to license private entities to engage in commercial cannabis activities and automatically expunge past marijuana convictions. 

Both measures failed to advance before the legislative session concluded in March, although lawmakers have expressed a willingness to hold additional hearings on medical cannabis legalization. 

Indiana: In Indiana, lawmakers have introduced several bills that would permit the use of medical marijuana by individuals with serious medical conditions determined by their physicians. The bills would establish programs for the cultivation, processing, testing, transportation, and dispensing of medical marijuana or cannabis, with oversight from state agencies. In addition, the bills require proper labeling, child-resistant packaging, and testing of products, prohibit packaging appealing to children, and authorize research on medical marijuana or cannabis.  

Tennessee: Tennessee’s Senate Bill 1104, presented by Republican state Sen. Janice Bowling, recently failed in the Senate Judiciary Committee on an almost a party-line vote of 6-3. Both Memphis Democrats on the committee, state Sens. London Lamar and Sara Kyle, were joined by one Republican, Springfield Sen. Kerry Roberts, in support of the bill. 

Georgia: Lawmakers in Atlanta introduced Senate Bill 350, which aims to increase the minimum age for purchasing medical marijuana in Georgia from 18 to 21. 

In 2021, Georgia Gov. Brian Kemp signed legislation to create a unique low-THC medical cannabis program. Patients suffering from debilitating illnesses. such as seizures, terminal cancers, Parkinson’s disease, and post-traumatic stress disorder can apply for a low-THC oil registry card. These registered patients are only permitted to purchase cannabis oils that contain no more than 5% THC. The legislation authorized up to 30 licensed retailers of these products statewide.

Seven Georgia dispensaries are operational, with the first opening in April 2023. Last year, Gov. Kemp authorized regulations that allow traditional pharmacies to sell these products as well, although the federal Drug Enforcement Administration (DEA) warned that dispensing cannabis by pharmacies would violate federal law, potentially leading to arrests or fines. 

Kansas: Kansas Republican Sen. Robert Olson proposed Senate Bill 135, which would allow patients access to medical marijuana with the state, charging a 10% retail excise tax. However, Republican leadership has refused to advance the bill in the Senate and removed Olson from his chairmanship of the State and Federal Affairs Committee after he held hearings on the medical cannabis bill. Although Olson found an ally in Democratic Gov. Cindy Holscher, Olson believes state Senate leadership does not want a bill to pass. 

“The majority of the state [does] want medical marijuana,” Gov. Olson said, according to Marijuana Moment, “and I don’t see a reason why we don’t pass a bill.”

Smaller action states with marijuana decriminalization bills 

In addition to states considering the legalization of cannabis for recreational or medical use, a few have considered decriminalization.

Florida: In Florida, Senate Bill 94 would have reduced criminal penalties for a first, second, or third violation if the offense is the possession of 20 grams or less of cannabis. However, it died in the Senate Criminal Justice Committee on March 8.  

South Carolina: In addition to South Carolina’s medical marijuana bill mentioned above, the House is currently considering a bill to decriminalize possession of 28 grams—one ounce or less—of marijuana, or 10 grams or less of hashish, and to authorize law enforcement to issue a civil citation for possession of that same quantity of marijuana or hashish.   

Conclusion 

State legalization of marijuana continues to gain momentum. In the 26 years since California voters first approved a medical marijuana market and the 12 years since Colorado and Washington voters first approved the legal recreational use of marijuana, numerous states have iterated and developed different governing structures for these markets.

In looking at best practices, some states’ legalization efforts have proven more successful than others in displacing illicit cannabis markets and improving public safety, and it is clear the details of legalization policy matter immensely. 

While marijuana legalization itself is an important step in the right direction, policymakers should ensure marijuana markets are open and competitive and offer legitimate pathways to entrepreneurship for individuals from all walks of life. 

The post Examining the 2024 state marijuana legalization proposals appeared first on Reason Foundation.

The last decade has seen an explosion of opioid addiction and overdose deaths, a public health crisis fueling demand for medical and governmental intervention. This brief is a comprehensive overview of the reported results of studies investigating the potential of ibogaine, a psychoactive compound derived from the Tabernanthe iboga plant, in treating opioid addiction.

Existing Medication-Assisted Treatments (MATs), also referred to as Medications for Opioid Use Disorder (MOUD), are examined as a frame of reference. Outcome measures examined include withdrawals and craving, retention, relapse, abstinence duration, mortality, adverse events, risk of diversion, short-term abstinence, long-term abstinence, program costs, and depression.

A consistent theme emerges from the research conducted to date into ibogaine as a prospective treatment for opioid use disorder (OUD): Ibogaine and ibogaine analogues are the only known treatments that consistently and immediately reduce both physical withdrawal symptoms from opioid addiction and psychological dependence without the need for ongoing medication. However, there are no large-scale studies of ibogaine, and more research is needed to understand if it could satisfy patients’ medical needs.

Existing challenges of MATs include increased mortality rates following treatment cessation, high relapse rates, low retention rates, adverse events that include respiratory depression and QT prolongation, risk of diversion, and limited access. Some studies suggest ibogaine treatment is more effective than MATs in combating these existing challenges.

Based on existing research, ibogaine therapy shows the potential to be an effective alternative treatment method for OUD. Its ability to reduce and eliminate opioid withdrawal and craving symptoms plays a key role in the reduction and abstinence of illicit opioid use. Hence, ibogaine can help users achieve lasting anti-addictive effects at fewer doses, whereas traditional MATs just abate dependence. Policymakers should consider ibogaine as a potential alternative treatment for opioid use disorder.

Nonetheless, it is still important to acknowledge the existence of potential safety risks associated with ibogaine treatment. More serious risks include cardiotoxicity and death. However, mitigation strategies have proven successful when administered in clinical settings.

For example, Deborah Mash’s ibogaine clinic in St. Kitts, West Indies, conducted 257 treatments from 1996 to 2004 without any related deaths or serious adverse events. Hence, professional oversight and proper clinical procedures are necessary conditions.

Several states participated in lawsuits against manufacturers and distributors of prescription opioids and received large settlement funds that are largely restricted for programs intended to abate the impact of opioid addiction. One potential avenue for doing this is to advance the development of a therapy that may allow individuals to overcome opioid addiction in as little as one treatment.

Based on the clinical and academic studies reviewed here, traditional abatement mechanisms present many challenges for recovering addicts and have demonstrated only limited success in helping opioid-addicted persons overcome their addiction. By contrast, early research shows ibogaine treatment may be a far more promising approach that enables rapid and sustained recovery from addiction.

The state of Kentucky was the first to consider this possibility. Kentucky received $842 million in settlement proceeds from its participation in a multistate lawsuit. Former Attorney General Daniel Cameron then established a Kentucky Opioid Abatement Advisory Commission to direct the allocation of these funds toward abatement programs.

Throughout a series of public hearings in 2023, the commission considered allocating $42 million—roughly 5% of Kentucky’s share of opioid settlement proceeds—toward Food and Drug Administration-supervised clinical trials that could lead to approval of ibogaine or its derivatives as a treatment for opioid use disorder. In December 2023, Russell Coleman succeeded Daniel Cameron as Kentucky Attorney General and pressed the commission for a change in direction. Chair Bryan Hubbard said he was asked to resign due to his support for funding ibogaine trials, and he was replaced with a former agent of the federal Drug Enforcement Administration.

However, the initiative first launched in Kentucky now continues elsewhere. In February 2024, Hubbard was retained by the Reaching Everyone in Distress (REID) Foundation, an Ohio-based nonprofit to advance FDA-supervised clinical trials for ibogaine. The REID Foundation will engage in broad based statewide advocacy for the creation of a public-private partnership to advance ibogaine or an ibogaine therapeutic through the FDA. ResultsOHIO has also retained Hubbard to explore projects related to the research, development, and delivery of novel therapeutics like ibogaine for treatment of traumatic brain injury and post-traumatic stress disorder. Despite the change of venue, Ohio is poised to capitalize on the materials accumulated by and on behalf of the Kentucky Opioid Abatement Advisory Commission, including the compilation of research presented here.

Based on the existing evidence, Reason Foundation concludes that the development of ibogaine as a pharmaceutical treatment for opioid use disorder may be the most cost-effective use of funds earmarked for mitigating the harms of the opioid epidemic.

Read the full Policy Brief here:

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