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.

Topic PTSD
Compound MDMA
Country Canada
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Trial Details



Trial Number

Sponsors & Collaborators

Remedy
Remedy is a psychotherapy clinic and research group helping people living with a range of mental health disorders.

Data attribution

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