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MDMA (±3,4-methylenedioxymethamphetamine)-assisted therapy (MDMA-AT) was shown in previous clinical trials to have promising efficacy and safety for alleviating treatment-resistant posttraumatic stress disorder (PTSD). However, due to low ethnoracial diversity, the question remains as to whether ethnoracial minority participants would benefit similarly. Thus, a mixed-methods case study was conducted on a participant of color from an open-label trial of MDMA-AT for PTSD to provide a culturally informed lens on symptom recovery with this treatment approach. An additional aim was to elucidate mechanisms of change underlying this treatment for the participant. A case profile was provided, documenting quantitative improvement in PTSD symptoms. This was followed by an interpretative phenomenological analysis (IPA) of effects and mechanisms of action for this participant, based on integration session transcripts. Results of IPA indicated recurrent themes related to psychological mechanisms of symptom change, reduced PTSD symptoms, and additional effects (positive and negative) beyond PTSD symptom reduction. These themes were discussed and recommendations for attuning to culturally relevant material during MDMA-AT were provided. [ABSTRACT FROM AUTHOR]

Introduction: There is a resurgence of interest in the therapeutic potential of psychedelic substances such as 3,4-methylenedioxymethamphetamine (MDMA). Primary findings from our randomized, double-blind, placebo-controlled, multi-site Phase 3 clinical trial of participants with severe PTSD (NCT03537014) showed that MDMA-assisted therapy induced significant attenuation in the Clinician-Administered PTSD Scale for DSM-5 compared to Therapy with placebo. Deficits in emotional coping skills and altered self-capacities constitute major obstacles to successful completion of available treatments. The current analysis evaluated the differential effects of MDMA-assisted therapy and Therapy with placebo on 3 transdiagnostic outcome measures and explored the contribution of changes in self-experience to improvement in PTSD scores. Methods: Participants were randomized to receive manualized therapy with either MDMA or placebo during 3 experimental sessions in combination with 3 preparation and 9 integration therapy visits. Symptoms were measured at baseline and 2 months after the last experimental session using the 20-item Toronto Alexithymia Scale (TAS-20), the 26-item Self Compassion Scale (SCS), and the 63-item Inventory of Altered Self-Capacities (IASC). Results: 90 participants were randomized and dosed (MDMA-assisted therapy, n = 46; Therapy with placebo, n = 44); 84.4% (76/90) had histories of developmental trauma, and 87.8% (79/90) had suffered multiple traumas. MDMA-assisted therapy facilitated statistically significant greater improvement on the TAS-20, the SCS, and most IASC factors of interpersonal conflicts; idealization disillusionment; abandonment concerns; identity impairment; self-awareness; susceptibility to influence; affect dysregulation; affect instability; affect skill deficit; tension reduction activities; the only exception was identity diffusion. Conclusion: Compared with Therapy with placebo, MDMA-assisted therapy had significant positive effects on transdiagnostic mental processes of self-experience which are often associated with poor treatment outcome. This provides a possible window into understanding the psychological capacities facilitated by psychedelic agents that may result in significant improvements in PTSD symptomatology. [ABSTRACT FROM AUTHOR]

This document is a retraction note for an article titled "Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials." The retraction was made after the editors were informed of protocol violations and unethical conduct at the MP4 study site by researchers associated with the project. The authors confirmed that they were aware of these violations but did not disclose the information to the journal or remove the data generated by the site from their analysis. The authors also did not fully declare a potential competing interest, as several of them are affiliated with the Multidisciplinary Association for Psychedelic Studies (MAPS) or MAPS Public Benefit Corporation (MAPS PBC), which funded and organized the trial. [Extracted from the article]