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

In Brazil's first clinical trial of MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD), three patients with PTSD from sexual abuse completed treatment. The protocol involved 15 weekly therapy sessions, with three sessions including orally administered MDMA combined with psychotherapy and music, spaced about a month apart. Two months after the final MDMA session, all three patients showed clinically significant improvement, with CAPS-4 scores dropping by more than 30% from baseline. Final scores were 61, 27, and 8, down from 90, 78, and 72. No serious adverse events occurred; common side effects were somatic pains and anguish. Secondary outcomes also improved. MDMA-assisted psychotherapy could become a viable PTSD treatment in Brazil.

Study at a glance

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.