Culturally informed research design issues in a study for MDMA-assisted psychotherapy for posttraumatic stress disorder

Psychedelic drugs combined with psychotherapy can help people change, and MDMA-assisted psychotherapy is being studied for posttraumatic stress disorder by reducing fear of traumatic memories and increasing trust and compassion without blocking access to difficult emotions. However, research has largely excluded people of color, leaving important questions unaddressed. At the University of Connecticut, a study site in a MAPS-sponsored, FDA-reviewed Phase 2 open-label multisite trial focused on providing culturally informed care to ethnic minority participants.

Study at a glance

Abstract

Recent research suggests that psychedelic drugs can be powerful agents of change when utilized in conjunction with psychotherapy. Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy has been studied as a means of helping people overcome posttraumatic stress disorder, believed to work by reducing fear of traumatic memories and increasing feelings of trust and compassion toward others, without inhibiting access to difficult emotions. However, research studies for psychedelic psychotherapies have largely excluded people of color, leaving important questions unaddressed for these populations. At the University of Connecticut, we participated as a study site in a MAPS-sponsored, FDA-reviewed Phase 2 open-label multisite study, with a focus on providing culturally informed care to people of color. We discuss the development of a study site focused on the ethnic minority trauma experience, including assessment of racial trauma, design of informed consent documents to improve understanding and acceptability to people of color, diversification of the treatment team, ongoing training for team members, validation of participant experiences of racial oppression at a cultural and individual level, examination of the setting and music used during sessions for cultural congruence, training for the independent rater pool, community outreach, and institutional resistance. We also discuss next steps in ensuring that access to culturally informed care is prioritized as MDMA and other psychedelics move into late phase trials, including the importance of diverse sites and training focused on therapy providers of color.