The Food and Drug Administration granted breakthrough therapy status to MDMA-assisted therapy in 2017 based on early evidence for treating PTSD. Across six phase-II trials, 54% of participants receiving a full dose no longer met PTSD diagnosis after two sessions, compared to 23% in the control group. In the first phase-III trial, 67% no longer met criteria after three sessions. Effects persisted: 67% remained undiagnosable after one year and 74% after nearly four years. The therapy was being fast-tracked for potential FDA approval by 2023. Hawaii's 2021 Senate Bill 738, which unsuccessfully sought to reschedule psilocybin for major depressive disorder, highlighted that MDMA, also a Schedule I substance, could benefit Hawaii residents.
In 2021, phase 3 clinical trials of MDMA-assisted therapy for treatment-resistant PTSD found that 71.2% of full-dose participants no longer met PTSD criteria. Although MDMA-assisted therapy is not FDA-approved for borderline personality disorder, its beneficial effects might be applicable. An exploratory, qualitative, interview-based study examined clinicians' perspectives by interviewing two dialectical behavioral therapy clinicians and two MDMA-assisted therapy clinicians. The study assessed underlying therapeutic mechanisms, pharmacological factors, and treatment context to improve clinical responses. Participants' codes revealed a chronological narrative with three treatment phases.
Borderline personality disorder (BPD) is often misunderstood, misdiagnosed, and stigmatized, with 25–58% of individuals also having post-traumatic stress disorder (PTSD). In Phase 3 clinical trials, up to 71.2% of full-dose MDMA participants for treatment-resistant PTSD no longer met PTSD criteria. This qualitative study interviewed two clinicians treating BPD and two MDMA-assisted therapy clinicians, exploring overlaps in etiology and conceptualization. Through eight interviews, perspectives revealed similarities and limitations of both dialectical behavioral therapy and MDMA-assisted therapy.