After a 50-year hiatus, psychedelic drugs are undergoing a research renaissance. Roland R. Griffiths, professor in the Departments of Psychiatry and Neuroscience and the Oliver Lee McCabe, III Professor in the Neuropsychopharmacology of Consciousness, and director of the Center for Psychedelic and Consciousness Research at Johns Hopkins University, Baltimore, Maryland, discusses the status of these drugs in the United States and their potential to treat psychiatric disorders.
Classic psychedelics are compounds that bind to the 5-hydroxytryptamine 2A (5-HT2A) receptor and include the naturally occurring compounds psilocybin, N,N-dimethyltryptamine (DMT, a component of ayahuasca) and mescaline (peyote cactus), as well as the synthesized compound lysergic acid diethylamide (LSD).
Other drugs, such as ketamine, are sometimes referred to as "psychedelics" because they can produce subjective experiences that are similar to those of people who receive classic psychedelics. However, unlike classic psychedelics, the effects of ketamine tend to be short-lived. Ketamine also has addictive potential and can be lethal in high doses, which is not the case with psilocybin.
Another compound sometimes referred to as a "psychedelic" is 3,4-methylenedioxymethamphetamine (MDMA), also known as "ecstasy." The US Food and Drug Administration (FDA) granted breakthrough approval for the study of MDMA for posttraumatic stress disorder (PTSD). FDA-approved registration trials are ongoing. MDMA differs from classic psychedelics in risk profile and pharmacology. In particular, MDMA was widely abused as part of the "rave culture," while classic psychedelic agents do not lend themselves to that type of misuse.
What is the current legal status of psychedelic agents in the United States? Can clinicians prescribe them, or are they available only in a research setting?All classic psychedelics are considered to be "Schedule 1" which means they are illegal to possess and use except for research and only if approved by the FDA and under licensure of the Drug Enforcement Administration (DEA), so they are not available for clinical use.
In anticipation of the possibility that phase 3 research may support the efficacy and safety of psilocybin for one, or more, medical or mental health disorders, our team has reviewed available evidence regarding its abuse liability and concluded that if psilocybin were approved as medication, it could possibly be included in the Schedule IV category, with additional FDA-mandated risk management provisions. However, this is not yet the case.
Which psychedelic agents are under investigation in the United States, and for which indications?Psilocybin is under investigation in our center, as well as elsewhere in the United States. We have previously found it to be effective for smoking cessation and we are conducting another study that is currently recruiting volunteers for this indication. We are also recruiting volunteers for studies on the use of psilocybin for major depression, Alzheimer’s disease, and anorexia nervosa. Further information about our studies can be found on our center's Web site.