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3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for victims of sexual abuse with severe post-traumatic stress disorder: an open label pilot study in Brazil.

Alvaro V Jardim, Dora V Jardim, Bruno Rasmussen Chaves, Matheus Steglich, Marcela Ot'Alora G, Michael C Mithoefer, Dartiu X Da Silveira, Luís F Tófoli, Sidarta Ribeiro, Rebecca Matthews, Rick Doblin, Eduardo E Schenberg

Revista Brasileira de Psiquiatria 2021 DOI: 10.1590/1516-4446-2020-0980 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Open-label clinical trial Pilot study Peer reviewed
Sample size 3
Population Patients with PTSD secondary to sexual abuse
Intervention MDMA-assisted psychotherapy
Duration 15 weekly therapy sessions with three MDMA sessions spaced approximately 1 month apart, plus 2-month follow-up
Topics Psychedelic-assisted therapy MDMA PTSD
Keywords MDMA Therapy MDMA-Assisted Psychotherapy Ecstasy therapy MDMA Treatment PTSD Treatment Trauma therapy PTSD Recovery Trauma healing Trauma recovery Sexual abuse healing Abuse recovery Healing from trauma Survivor support Clinical research Pilot investigation Medical study Therapy trials Drug research
Citations 54
Key findings All three patients showed clinically significant improvement in PTSD symptoms after MDMA-assisted psychotherapy, with CAPS-4 score reductions greater than 30% from baseline.

Abstract

To conduct Brazil's first clinical trial employing 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder (PTSD), given its high prevalence resulting from epidemic violence. Of 60 volunteers, four matched the inclusion & exclusion criteria. Three patients with PTSD secondary to sexual abuse (diagnosed by the Structured Clinical Interview for DSM-IV and the Clinician Administered PTSD Scale for DSMV-4 [CAPS 4]) completed enrollment and treatment, following a standardized Multidisciplinary Association for Psychedelic Studies protocol consisting of 15 weekly therapy sessions: three with orally administered MDMA with concurrent psychotherapy and music, spaced approximately 1 month apart. CAPS-4 scores two months after the final MDMA session were the primary outcome. No serious adverse events occurred. The most frequent adverse events were somatic pains and anguish. CAPS-4 reductions were always greater than 25 points. The final scores were 61, 27, and 8, down from baseline scores of 90, 78, and 72, respectively. All reductions were greater than 30%, which is indicative of clinically significant improvement. Secondary outcomes included lower Beck Depressive Inventory scores and higher Post-Traumatic Growth Inventory and Global Assessment of Functioning scores. Considering the current limitations in safe and efficacious treatments for PTSD and recent studies abroad with larger patient samples, MDMA-assisted psychotherapy could become a viable treatment in Brazil. RBR-6sq4c9.

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
Culturally informed research design issues in a study for MDMA-assisted psychotherapy for posttraumatic stress disorder People of color with posttraumatic stress disorder 2019 Phase 2 open-label multisite study
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
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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