RECRUITING, RETAINING, AND TAILORING PSYCHEDELIC CLINICAL TRIALS FOR VULNERABLE POPULATIONS

Psychedelic-assisted therapy has shown signals of efficacy for a variety of mental health conditions, but participants in psychedelic clinical trials have not been representative of the broader populations most affected by these conditions. A recent systematic review of 49 primary trials of psychedelics and MDMA for mental health conditions found that only 12% reported participant income and 31% reported educational attainment. In US-based trials that did report these data, participants had markedly higher socioeconomic status than the general population, with 93% having some college education versus 62% nationally. This lack of socioeconomic diversity limits the generalizability of existing findings and raises concerns about equitable access to psychedelic therapies as they move toward clinical implementation. This presentation will draw on three lines of research addressing the recruitment, retention, and tailoring of psychedelic clinical trials for vulnerable populations, with a focus on economically disadvantaged individuals. First, a conceptual framework for evaluating psilocybin-facilitated psychotherapy in vulnerable populations will be discussed, including barriers to participation like logistical constraints, mistrust of medical research, and the need for culturally informed consent procedures. Second, findings from a systematic review documenting the extent of socioeconomic underrepresentation in psychedelic trials will be presented, underscoring the need for standardized socioeconomic data reporting and targeted enrollment strategies. Third, data from a recently completed randomized controlled trial of psilocybin for cocaine use disorder (Hendricks et al., in press) will be shared. This quadruple-blind, placebo-controlled trial enrolled 40 adults with cocaine use disorder at a major medical research center in the Deep South of the US. Participants were predominantly Black (82.5%), male (82.5%), and of lower socioeconomic status (65% annual income at or below $20,000). Psilocybin recipients had a significantly higher percentage of cocaine abstinent days, greater likelihood of complete cocaine abstinence, and reduced risk of cocaine lapse through 180 days after end-of-treatment compared to placebo recipients. No serious adverse events occurred. These findings indicate that psychedelic clinical research can be feasibly and safely conducted with underrepresented and vulnerable populations when appropriate considerations are made around recruitment, retention, and therapeutic context. Recommendations for designing more inclusive psychedelic trials will be discussed, along with strategies for addressing the specific needs of economically disadvantaged communities so that the benefits of psychedelic therapies are not limited to those already well-served by the current research enterprise.

References

Ortiz CE, Dourron HM, Sweat NW, Garcia-Romeu A, MacCarthy S, Anderson BT, Hendricks PS. Special considerations for evaluating psilocybin-facilitated psychotherapy in vulnerable populations. Neuropharmacology. 2022;214:109127. Hendricks PS, Grossman DH, Ortiz CE, Lappan SN, Bradley M. A systematic review of income and education reporting in psychedelic clinical trials. Nature Mental Health. 2025;3:567–574. Hendricks PS, et al. Psilocybin in the Treatment of Cocaine Use Disorder: A Randomized Clinical Trial. JAMA Network Open.