Trustworthy, Responsible, and ethical Integration of Psychedelics in Psychiatry

After nearly a 50-year hiatus, there has been a resurgence of research on the use of psychedelics to treat a wide range of neuropsychiatric conditions. The FDA designated MDMA and psilocybin breakthrough therapies for PTSD and severe depression, respectively and is anticipated to approve the first psychedelic drug within the next two years. The therapeutic potential of psychedelics has been widely publicized, and patients are now inquiring about the availability and advisability of psychedelic use. Meanwhile, several US cities and both Oregon and Colorado have decriminalized or deprioritized enforcement for at least some psychedelics, with many others considering similar legislation. This growing public enthusiasm, combined with bipartisan advocacy for regulatory reform, has led to an increase in the number of companies offering private or group psychedelic retreats, often without the involvement of licensed healthcare professionals. Yet little is known about how these retreats are run, and because they typically take place in other countries, there is no oversight of their practices. Ethical concerns are mounting regarding potential for off-label and unregulated use of psychedelics without a corresponding evidence-base, leap-frogging established and safe interventions, and commercial abuse. Unchecked, such issues pose clear risk for the responsible and safe uptake of psychedelic therapies that could affect consumer safety, have legal implications, and deleteriously impact patient trust in psychiatric practice. Despite these concerns, no studies to date have systematically examined the use of psychedelics in these unregulated settings or the ethical, legal, and social implications of such use.  

The overall goal of this research is to examine the appropriate role (scope, value, and legitimacy) of healthcare gatekeeping for ensuring safe and responsible use of psychedelics.  

Specific aims of this project include: 

• Assess the current state of unregulated psychedelic retreats that are advertised in the U.S.
• Examine the ethical, legal, and social implications of these programs from the perspective of those participating in them.
• Provide recommendations for the appropriate role (scope, value, and legitimacy) of healthcare gatekeeping in the context of unregulated psychedelic retreats, informed by the results of the first two aims. 

Funded by: The Ortus Foundation

• NPR - Should psychedelic drugs be used to treat PTSD and depression in veterans? – Houston Public Media
• WBUR - Psychedelics and who should be able to use them
• WIRED - The Therapy Part of Psychedelic Therapy Is a Mess | WIRED
• New York Times - The Psychedelic Evangelist