The Changing Landscape of Psychedelic Research in the United States

Indigenous cultures around the world have ritually used mind-altering substances like ayahuasca, psilocybin, and peyote for thousands of years. In the United States, research explorations continued with legal sanction well into the twentieth century: psychedelic-aided therapy was actually a rapidly expanding field in the years after World War II. Conditions as diverse as substance abuse and addiction, post-traumatic stress disorder (PTSD), and anxiety were treated with hallucinogens. Between 1945 and 1970, nearly 40,000 research subjects were given psychedelics including psilocybin, LSD, DMT, and mescaline. More than 1,000 studies were undertaken. The results were promising, although much of the research lacked proper protocol. In some LSD studies, for example, patients were injected with the drug, strapped into restraints, and left unattended for hours. Experiments often occurred in drab, clinical settings. At the other end of the spectrum was a growing public interest in the use of hallucinogens for expanding consciousness.

The federal government took notice. The Nixon administration's concern over the rise of a drug-fueled counterculture culminated in the Controlled Substances Act of 1970. The law created five levels of severity by which drugs were to be classified. At points thereafter, psilocybin, MDMA, LSD, ibogaine, and peyote were categorized as Schedule I drugs, the most restrictive level. Schedule I classification is reserved for substances that, by the government's definition, have a "high potential for abuse," "no currently accepted medical use," and a "lack of accepted safety."

Despite their rich history as therapeutic mental health treatments, psychedelics have been notably restricted by Schedule I classification, even within scientific and medical communities. Stephen Ross, MD, associate professor of Psychiatry at New York University School of Medicine, shares the following description of his medical education: "The only thing I learned about psychedelics in psychiatry training is that they were toxic. We were told that they cause psychosis. I'd also heard the old urban legends: that they cause chromosomal damage, and that if you take seven hits of LSD you go insane." By stigmatizing and criminalizing the use of hallucinogens, the Controlled Substances Act brought an end to psychedelics research in the United States for nearly 25 years.

Several research organizations - the Multidisciplinary Association of Psychedelic Studies (MAPS) and the Heffter Research Institute, among others - have worked diligently to sponsor federally-approved studies at distinguished universities, serve as clearinghouses for best practices in psychedelic research, and host conferences that have allowed psychedelic scholars to share the results of their work and to collaborate on cutting-edge projects. These visionary groups' efforts to highlight the therapeutic value of psychedelics gradually softened attitudes within the Drug Enforcement Administration and universities' institutional review boards, creating research opportunities unseen in a generation. Today, scholars are again exploring the possibilities of psychedelics for the treatment of PTSD, substance abuse, and anxiety associated with chronic and terminal illnesses.

After establishing the safety of hallucinogens in Phase I trials, most psychedelic studies currently underway are classified as Phase II by the Food and Drug Administration. Phase I studies determine whether a substance is safe by testing ascending subtherapeutic doses on small groups (20-100 healthy volunteers). Substances that can be safely administered progress to Phase II trials, in which efficacy is measured by testing therapeutic doses on larger groups (100-300 volunteers and patients). Phase III studies continue to assess safety and effectiveness through randomized controlled trials with very large groups (300 or more patients).

Most contemporary psychedelic research has been conducted at major medical schools with psychiatrists and clinical psychologists as crucial members of the research team.  What is needed now, as the field reestablishes itself and studies grow in size and scope, is a whole new cadre of specially trained therapists equipped with advanced skills to conduct this research.  Those therapists need to be trained in the effective, scientifically rigorous research methods and protocols necessary to safely achieve accurate, applicable, and replicable results. Additionally, guiding clients through psychedelic experiences and assisting them toward successful integration afterward requires specific attending skills not taught in traditional psychology education. Therapists must learn to identify cues that indicate the healthy or unhealthy progression of a psychedelic session, to reduce anxiety by physically and emotionally grounding clients, and to encourage constructive self-reflection and healing throughout the experience.

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