Including Sexually and Gender Diverse Populations in 3,4-Methylenedioxymethamphetamine–Assisted Psychotherapy Trial Research

Sexually and gender diverse (SGD) populations experience an increased prevalence and severity of posttraumatic stress disorder (PTSD) compared with the general population. Minority stress theory contextualizes this increased disease burden by outlining how stigma and discrimination (e.g., homophobia and transphobia) contribute to worse mental health outcomes. The standard-of-care pharmacotherapy for PTSD is associated with significant treatment resistance. 3,4-Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy (MDMA-AP) has emerged as an investigational treatment for PTSD but has lacked consideration for SGD populations. This article explores next steps in clinical trial design and implementation for the study of MDMA-AP with SGD populations who have PTSD.