Special considerations for evaluating psilocybin-facilitated psychotherapy in vulnerable populations

Introduction

Ortiz and colleagues note that psilocybin-facilitated psychotherapy has accumulating evidence of efficacy across several mental health conditions, yet people from vulnerable populations—defined here as underresourced social groups at elevated risk for poor health outcomes—have been largely underrepresented in clinical psilocybin research. The Introduction situates this gap within broader calls for multicultural competence in mental health care, emphasising the importance of understanding patients' lived experience and provider identity when working with groups such as socioeconomically disadvantaged individuals, people experiencing homelessness, racial/ethnic minorities, sexual and gender minorities (SGM), older adults, people with disabilities or chronic conditions (for example, HIV), and people involved with the criminal justice system. This report, presented as an invited talk at the NIH Psilocybin Research Speaker Series, sets out to provide a concise primer on advancing culturally informed evaluation of psilocybin treatments in vulnerable populations. Rather than exhaustively treating any single group, the authors aim to highlight cross-cutting historical, ethical, methodological, and practical issues and to offer actionable recommendations to improve recruitment, assessment, therapeutic practice, and study design when working with these populations.