Applying lessons from cannabis to the psychedelic highway: Buckle up and build infrastructure

In 2020, Oregon became the first state in the United States to decriminalize use of many illicit substances (e.g., psilocybin-containing mushrooms) and allow adults 21 and older to take psilocybin under supervision in state-licensed service centers. Numerous states and municipalities have since proposed similar policies,¹ a process catalyzed by excitement about positive clinical trials of psychedelics for psychiatric conditions^2,3 and the entry of commercial interests into psychedelic drug development.

The déjà vu with cannabis policy is remarkable. Over the past 25 years, cannabis liberalization advanced quickly, justified by arguments for compassionate use, personal freedom, and frustration towards national drug policies. Indeed, despite federal criminalization, cannabis products are a mainstay in many states, supported by the considerable unmet need for alternative therapies aimed at difficult-to-treat conditions (e.g., chronic pain), changing public perceptions, and exponential market growth. Similarly criminalized and supported by comparable arguments, psychedelics are poised to follow a parallel pattern, reinforced by the Food and Drug Administration designating psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) as breakthrough therapies for major depressive disorder and post-traumatic stress disorder, respectively. With this context, we believe the momentum behind psychedelic decriminalization is unlikely to diminish. Thus, to effectively navigate forward with psychedelics, we would be wise to learn from the lessons of cannabis liberalization.

Cannabis liberalization advanced via “medical marijuana” policies, which designated certain conditions/symptoms as qualifying for medical cannabis licensure. Scientific inquiry around therapeutic uses of cannabis was stifled by federal drug policy,⁴ so qualifying conditions were strongly influenced by patient advocacy rather than comprehensive scientific data. While physicians recommend medical cannabis for patients with qualifying conditions, they typically cannot prescribe treatment regimens and there are few requirements for follow-up care or rigorous data collection on health outcomes. Further, many physicians hesitate to discuss cannabis with patients because they fear legal consequences or feel unprepared to offer guidance, essentially ceding control of cannabis to patients, non-medically trained dispensary employees, and the cannabis industry. This disconnect enhances the risk of negative side effects, demonstrated by increased cannabis-related emergency department visits⁵ and the prevalence of highly concentrated products with dubious medical value, such as dabs. Few states have attempted to moderate these avoidable harms, e.g., by standardizing training and dispensing mandates for dispensary employees or guaranteeing appropriate education for physicians.⁶ Taken together, medical cannabis policies have effectively expanded cannabis access and industry power while doing little to integrate cannabis into medical practice, track health outcomes, or promote safe use.

Extrapolating the cannabis landscape to psychedelics, this lack of integration is troubling as oversight of psychedelic administration in clinical trials by experienced monitors (e.g., therapists, physicians, social workers, and other individuals trained in psychedelic-assisted therapy) likely decreases the probability of severe adverse reactions and enhances treatment success.⁷ Indeed, the effects shown in clinical trials were achieved with ≥10 hours of psychotherapy prior to and after administration,^2,3 and the presence of two trained monitors during dosing sessions (~8 hours/session). Further, the heightened suggestibility and emotional/spiritual openness elicited by psychedelics is potentially exploitable, demonstrated by recent revelations of decades-long, systematic abuse by prominent psychedelic therapists.⁸ Indeed, the ethical imperative to do no harm while working with individuals in a vulnerable, drug-induced state cannot be overemphasized.

As has been argued with cannabis,⁴ developing coherent federal policy would jumpstart vital research to adequately assess the therapeutic potential of psychedelic compounds. However, federal change has not yet materialized as state and municipal decriminalization efforts continue accelerating. Further, societal parallels with cannabis (widespread interest based on therapeutic potential, commercial interests, rapid policy change) and legal precedents set by the national cannabis industry selling Schedule I drugs for medical reasons leave us doubtful that society will pump the brakes on psychedelic decriminalization.

Drawing from the lessons of cannabis, we advocate that psychedelic policy move beyond the cannabis liberalization movement’s emphasis on drug access. Although observational studies suggest that some individuals may derive benefit from naturalistic use alone or with friends/guides, the strongest evidence supports pairing psychotherapy with psychedelics after careful screening (e.g., for heart arrythmias, personality disorders) to maximize treatment safety and success. Thus, pragmatic and safety-oriented policy should focus on minimizing harm and maximizing benefits by developing appropriate therapeutic infrastructure—the regulatory equivalents of seatbelts, traffic lights, and speed limits. We offer recommendations to address this goal.

First, as with cannabis, few monitors are trained to skillfully manage psychedelics clinically, highlighting the need for expanded educational opportunities for interested monitors and students. Organizations such as Fluence and the Multidisciplinary Association for Psychedelic Studies have substantial experience offering monitor trainings, largely focused on building skills around drug administration, harm reduction, and psychedelic integration therapies. Efforts are also underway at the Center for Psychedelic Drug Research and Education at The Ohio State University to create the first academically accredited continuing education certificate program and undergraduate minor in psychedelic studies. Such training efforts are vital given that communities, families, and the public will need education to better understand and support loved ones who may seek out treatment(s).

Second, the extensive time commitments required for monitors to provide this intervention creates an accessibility problem. Creative policy could expand availability considerably. For example, preparation and integration could be transformed into group therapy sessions, as piloted in a recent clinical trial of demoralization among AIDS survivors.⁹ Similarly, psychedelics could be administered to cohorts of up to 6 people at once with shared guidance by trained monitors, as in a recent trial among healthy volunteers.¹⁰ Similarly to cannabis, monitored psychedelic-assisted therapy will likely only be available to those who can pay out-of-pocket, with boutique offerings in wealthier areas. Policies could include pilot programs that creatively democratize access to medical supervision for decriminalized psychedelic use, such as offering incentives for monitors offering medical guidance in low socioeconomic status communities. Additionally, scholarships that offset high training costs for monitors, especially people of color and gender/sexual minorities, could help ensure equity in dissemination efforts.

Third, we should improve upon the cannabis landscape by implementing systematic real-world data collection on treatment outcomes and adverse events where decriminalization has occurred (e.g., Oregon). This would allow policymakers to nimbly respond to issues that arise using relevant data and also act as a complementary data source to inform clinical trials. As these therapies have only been tested among limited sociodemographic samples in clinical trials, such data would help clarify whether potential benefits and harms extend to other populations, such as the elderly, non-White populations, individuals not meeting stringent trial exclusion criteria.

Fourth, we believe that these recommendations should be embedded within psychedelic decriminalization efforts, as doing so would proactively build necessary infrastructure rather than trying to address it later.

Stanislov Grof wrote that the “potential significance of… psychedelics for psychiatry and psychology [is] comparable to the value the microscope has for biology or the telescope has for astronomy”. As with telescopes or microscopes, trained hands and thoughtful, curious minds are essential to realizing the promise of psychedelics. The lessons of cannabis should also remind us that the medical utility of psychedelics is surely limited to specific circumstances, a narrative often forgotten amidst pervasive media hype. Consequently, our goal should be to craft balanced policy that appropriately shapes societal set and setting to facilitate safe experiences for people using these medicines, knowing that some will benefit and some will not.