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

Abstract

Objective: 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. Methods: 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. Results: 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. Conclusion: 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. Clinical trial registration: RBR-6sq4c9

MDMA-assisted psychotherapy for the treatment of PTSD

“…three in conjunction with MDMA, can lead to significant reductions in symptoms of PTSD as measured by the Clinician Administered PTSD Scale for DSM-IV (CAPS-4). 4 While Jardim et al's study only enrolled three participants, all three had clinically significant reductions in CAPS-4 scores of 32%, 65%, and 89% from baseline. Two of the patients no longer met criteria for PTSD at the end of the study.…”

“…There were no serious adverse outcomes. 4 Aside from providing more clinical data, Jardim et al's study demonstrates that the MAPS MDMA-AP protocol for PTSD can be administered by trained clinicians and researchers around the world. It suggests that MDMA-AP is scalable and has potential to be implemented in more countries that have a high prevalence of PTSD.…”

“… 2 At this time, there is a need for better treatments of PTSD in countries such as Brazil, where it is estimated that 5% of the civilian population met criteria for PTSD in the past year, and 10% of the population has met criteria for PTSD in their lifetime. 4 …”

Psychedelic drugs as new tools in psychiatric therapeutics

“…1 In this issue we report the successful results of MDMA-assisted psychotherapy for Brazilian patients with severe PTSD (summarized in Figure 1). 2 This approach deserves attention from mental health professionals nationwide, since the prevalence of this disorder, which is already high, is likely to increase as COVID-19 infections and fatalities escalate in Brazil. 3 Psychiatry's history with these drugs began around 1953, when psychiatrist Humphry Osmond handed a glass of water containing 400 mg of mescaline to Aldous Huxley, worrying he might drive the famous writer mad.…”

“…Details on the methods and results are reported by Jardim et al in this issue. 2 ''mind manifesting''), reasoning that: ''The name should have a clear meaning, be reasonably easy to spell and pronounce and not be too like some other name. [...] Psychedelic seems unambiguous, not loaded with old associations and clear.''…”