A primer for culturally attuned psychedelic clinical trials

Abstract

AbstractBackgroundThere is a need to systemically diversify psychedelic clinical trials, considering the growing interest in in the therapeutic potential of psychedelics within Black, Indigenous, and Peoples of Color (BIPOC) and queer communities. Doing so contributes to a more inclusive foundation of evidence-based research and addresses ethical considerations surrounding anticipated demand for these treatments following regulatory approval. Cultural attunement may be key to facilitating effective research and ensuring equitable treatment.AimsHere, we introduce a primer for culturally attuned psychedelic clinical trials. We narratively review prevalent psychological and pragmatic barriers to diversity – as part of set and setting – in modern psychedelic trials. We also propose potential strategies for the culturally attuned recruitment, assessment, and retention of diverse participants.MethodsThis primer narratively synthesizes existing literature on barriers and potential strategies for culturally attuned psychedelic trials. Here, the scope is on classic psychedelics and other drugs with consciousness-altering effects (3,4-methylenedioxy-methamphetamine [MDMA], ketamine). The term ‘diversity’ focuses on BIPOC and sexual- and gender-diverse populations, primarily in the US.ResultsPsychological and pragmatic barriers include stigma, medical mistrust, history of psychedelic-assisted conversion therapy, income disparities, schedule inflexibilities, and transportation inaccessibility. Culturally attuned recruitment, assessment, and retention strategies include queering/diversifying the study team, debinarizing the therapist dyad, developing culturally attuned flyers, community outreach, using culturally attuned language, improving transportation-related access, diversifying room setup, and using culturally attuned assessments.ConclusionsPsychedelic research groups are encouraged to adapt and enact these recommendations in their clinical trials, to improve accessibility to innovative mental health treatments for diverse populations.