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

Monnica T. Williams, Sara Reed, Ritika Aggarwal

Journal of Psychedelic Studies July 30, 2019 DOI: 10.1556/2054.2019.016 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Phase 2 open-label multisite study Peer reviewed
Population People of color with posttraumatic stress disorder
Intervention MDMA-assisted psychotherapy
Topics MDMA Psychedelic-assisted therapy PTSD
Keywords Psychotherapist Cultural humility Outreach Ethnic group Informed consent Clinical psychology Cultural competence
Citations 87
Key points Providing culturally informed care to people of color in MDMA-assisted psychotherapy requires assessment of racial trauma, culturally adapted informed consent, diverse treatment teams, validation of racial oppression, and cultural congruence of session elements, alongside community outreach and addressing institutional resistance.

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.

Comparable studies

Other non-randomized and open-label trials on MDMA and psychedelic-assisted therapy, most cited first.

Study Year Design Participants
Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study. Adults with chronic, treatment-resistant PTSD 2013 Long-term follow-up of a completed trial n = 19
First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder. Patients with alcohol use disorder (AUD) following community alcohol detoxification 2021 Open-label safety and tolerability proof-of-concept study n = 14
First study of safety and tolerability of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in patients with alcohol use disorder: preliminary data on the first four participants. Patients with alcohol use disorder 2019 Open-label safety and tolerability proof of concept study n = 4
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil. Patients with PTSD secondary to sexual abuse 2021 Open-label clinical trial n = 3
Group psychedelic therapy: empirical estimates of cost-savings and improved access Adults with PTSD or major depressive disorder eligible for psychedelic-assisted therapy... 2023 Comparative cost analysis using trial data and published estimates

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