Here’s the Introduction
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In 2020, Oregon became the first state in the US to decriminalize use of many illicit substances, including mushrooms containing psilocybin, and allow adults aged 21 years 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 conditions2,3 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 and personal freedom and frustration toward 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, such as 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 US Food and Drug Administration designating psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) as breakthrough therapies for major depressive disorder and posttraumatic stress disorder, respectively. With this context, we believe that the momentum behind psychedelic decriminalization is unlikely to diminish. Thus, to effectively navigate forward with psychedelics, it would be wise to learn from the lessons of cannabis liberalization.
Cannabis liberalization advanced via medical marijuana policies, which designated patients with certain conditions and 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. Although physicians recommend medical cannabis for patients with qualifying conditions, physicians typically cannot prescribe treatment regimens. In addition, there are few requirements for follow-up care or rigorous data collection on health outcomes. Furthermore, many physicians hesitate to discuss cannabis with patients because physicians fear legal consequences or feel unprepared to offer guidance, essentially ceding control of cannabis to patients, nonmedically trained dispensary employees, and the cannabis industry. This disconnect enhances the risk of adverse 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 by, for example, standardizing training and dispensing mandates for dispensary employees or guaranteeing appropriate education for physicians.6 Taken together, though medical cannabis policies have effectively expanded cannabis access and industry power, they have done little to integrate cannabis into medical practice, track health outcomes, or promote safe use.
Extrapolating the cannabis landscape to psychedelics, we find this lack of integration troubling because oversight of psychedelic administration in clinical trials by experienced monitors, such as 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 or more hours of psychotherapy prior to and after administration2,3 and the presence of 2 trained monitors during dosing sessions (approximately 8 hours per session). Moreover, the heightened suggestibility and emotional and 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, though federal change has not yet materialized, state and municipal decriminalization efforts continue accelerating. Furthermore, societal parallels with cannabis (widespread interest on the basis of therapeutic potential, commercial interests, and 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 and guides, the strongest evidence supports pairing psychotherapy with psychedelics after careful screening (for example, for heart arrythmias and 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.