This interventional trial (n=20) will investigate the efficacy and safety of psychedelic-assisted psychotherapy for the treatment of PTSD in individuals diagnosed with co-occurring borderline personality disorder (BPD), using MDMA (2-5x; 80+40mg).
The study, conducted by Spectrum Personality Disorder Service for Victoria, aims to assess the feasibility and acceptability of integrating MDMA-assisted psychotherapy within a public mental health service. Participants will undergo six weeks of preparatory psychotherapy sessions, followed by two to five MDMA sessions over six months.
The control group will receive the same psychotherapy without MDMA. Primary outcomes include safety, feasibility, and cost, with secondary outcomes evaluating mood, dissociation, PTSD symptoms, and overall BPD pathology. The study, approved by the Eastern Health Human Research Ethics Committee, is scheduled to begin participant enrolment in July 2024.
Trial Details
Traumatic experiences and consequent development of trauma disorder (PTSD, complex-PTSD) frequently occurs in people diagnosed with borderline personality disorder (BPD). The only evidence-based treatment for BPD is psychotherapy, however this does not directly address the impact of trauma disorder which reduces the likelihood of achieving remission and recovery. The recent decision of the TGA to approve the prescription of 3,4-methylenedioxy-methamphetamine (MDMA) as an adjunct to psychotherapy represents a break-through that could dramatically improving treatment outcomes for BPD and post-traumatic stress disorder (PTSD or Complex-PTSD) when they co-occur. Spectrum is a specialist public mental health service that provides treatment for people experiencing severe, complex, and high-risk clinical presentations of BPD and trauma throughout Victoria. In this pilot study, we will conduct a controlled before and after pilot study to assess the feasibility and acceptability of offering MDMA-assisted psychotherapy in our specialist public mental health service. Given that the efficacy and safety of MDMA for the treatment of PTSD has already been established, our study will assess efficacy, safety, and cost-effectiveness as secondary outcomes. MDMA will be administered within an evidence-based psychotherapy program. The pilot study will entail recruiting participants diagnosed with PTSD (or C-PTSD) and co-occurring BPD. There are two arms in the study. In the first, six to eight participants will receive psychotherapy + MDMA while in the second arm, six to eight matched participants will receive psychotherapy only. A wide range of assessment and evaluation measures will be used, utilising quantitative and qualitative approaches to examine clinician assessed and participant self-reported outcomes.NCT Number ACTRN12624000871549