Altered stakes: Identifying gaps in the informed consent process for psychedelic-assisted therapy trials

Abstract Background and aims Psychedelic-assisted therapy (P-AT) has been shown to reduce post-traumatic stress disorder (PTSD), depression, and anxiety symptoms, and is likely to be approved in the United States (US) in the coming years. However, concerns about participant safety in these early trials have surfaced, including allegations of sexual misconduct. This paper aims to illuminate how potential risks have been communicated to P-AT participants via informed consent documents and to suggest how existing policy might be modified given the unique risks involved in P-AT trials.

Methods: Publicly available informed consent forms (ICFs) were gathered by searching clinicaltrials.gov . Queries were applied to filter trials involving the use of a classical psychedelic (psilocybin, LSD) or psychedelic-adjacent substance (MDMA, ketamine) in tandem with psychotherapeutic intervention and those with a status of “completed,” “recruiting,” or “active.” Results Nineteen ICFs met inclusion criteria and were reviewed to determine what risks, benefits, and safety protocols were communicated to participants in their respective trials. The primary finding from this review of ICFs from P-AT trials revealed that studies were in compliance with federal regulation. However, there were missing elements related to the vulnerability experienced while under the effects of psychedelics that warrant inclusion in future ICFs in P-AT trials.

Conclusion: Although the ICFs for P-AT trials examined in this study covered several important areas related to risk, benefits, safety, and accountability as required by federal regulations in the US, future research should consider ways to expand this content in order to assure that consent is truly informed prior to enrolling subjects.