MDMA-Assisted CBCT for PTSD vs CBCT RCT - Trial NCT06044675

Timeline & Enrollment

Primary Outcome

Feasibility of Intervention Measure (FIM),Safety of Intervention,Intervention Appropriateness Measures (IAM),Long Term Follow-Up Questionnaire (LTFUQ),Clinician Administered PTSD Scale (CAPS-5)

Summary

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.

ICD-10 Classifications