MDMA-Assisted CBCT for PTSD vs CBCT RCT

This interventional trial (n=60) aims to assess the efficacy and safety of MDMA-Assisted Cognitive-Behavioural Conjoint Therapy (CBCT) compared to CBCT alone in dyads where one member has Post-Traumatic Stress Disorder (PTSD).

The study, sponsored by Remedy, involves a 7-week psychotherapy course for 30 dyads, with one member having PTSD symptoms. In the experimental group, MDMA is integrated into the CBCT sessions, while the control group receives CBCT without MDMA initially but has the option to crossover later.

The primary goal is to evaluate the feasibility, safety, acceptability, and effectiveness of MDMA-assisted CBCT, comparing it to active PTSD treatments.

The study’s primary outcome measures include the Feasibility of Intervention Measure (FIM), Safety of Intervention, Intervention Appropriateness Measures (IAM), and Long-Term Follow-Up Questionnaire (LTFUQ). Secondary outcome measures encompass various assessments of PTSD symptoms, relationship quality, depressive symptoms, self-compassion, experiential avoidance, substance use, posttraumatic cognitions, social support, attachment style, acute experiences of insight, mystical experiences, suicidal behaviour, and treatment credibility.

The estimated start date for the study was October 15, 2023, with an estimated completion date of October 15, 2026. Participants must meet specific eligibility criteria, including being residents of Ontario within the Greater Toronto Area, being proficient in English, and agreeing to adhere to study rules and commitments.

Trial Details

This study aims to evaluate the safety, feasibility, acceptability, and effectiveness of MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) versus CBCT alone for the treatment of Post-Traumatic Stress Disorder (PTSD). PTSD is a debilitating condition that significantly impacts interpersonal relationships and the functioning of individuals and their loved ones. There is also a well-established reciprocal relationship between interpersonal relationships, PTSD, and recovery. CBCT is a manualized treatment for PTSD that simultaneously addresses PTSD symptoms and relationship satisfaction. It provides dyads with behavioral tools to navigate PTSD-related challenges, as well as the knowledge behind PTSD and how it impacts relationships. Previous research has demonstrated the efficacy of CBCT in improving PTSD symptoms, partner functioning, and relationship satisfaction in both distressed and non-distressed dyads. MDMA is a drug commonly used recreationally that has been increasingly studied because of its ability to reduce the impact of PTSD symptoms. The effects of MDMA are reduced fear, enhanced communication, trust and introspection, and increased empathy and compassion. The effects of MDMA create a state that enhances the positive effects of therapy by increasing the ability to tolerate negative emotions and allowing clients to stay engaged in therapy without being overwhelmed by the intense emotions surrounding the memories of traumatic events. It is believed that MDMA may help promote the effects of CBCT due to its ability to induce empathy and interpersonal openness. This randomized study is the second study designed to explore the efficacy of combining MDMA-assisted therapy with CBCT. This study will enroll 30 dyads, where one individual has symptoms of PTSD. Participants will undergo a 7-week psychotherapy course, in MDMA-assisted CBCT or CBCT alone. In the MDMA-assisted CBCT, participants will go through CBCT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Participants assigned to the CBCT-only condition will go through CBCT sessions and will have the opportunity to crossover and receive the two MDMA sessions after follow-up. The primary goal of this research is to contribute to the literature on MDMA-assisted CBCT by investigating its feasibility, safety, acceptability, and effectiveness, and by comparing it to active PTSD treatments.

NCT Number NCT06044675

Data attribution

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