A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD)

This open-label Phase II trial (n=10) investigates the safety and efficacy of MDMA-assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD).

PTSD severely impacts daily life, leading to decreased functioning, strained relationships, and mental health issues. CPT, a recognised treatment for PTSD, helps individuals process traumatic events and their impact. MDMA, known for reducing PTSD symptoms, enhances therapy by reducing fear, improving communication and trust, and promoting introspection. The study integrates CPT with MDMA-assisted psychotherapy, aiming to assess their combined effectiveness in treating PTSD.

Participants undergo a 2-month psychotherapy course, including CPT sessions integrated with two doses of MDMA. With this being the first integration of CPT with individual MDMA-assisted psychotherapy for PTSD, researchers seek preliminary insights into their combination.

The study, sponsored by Remedy, is conducted in Toronto, Canada, from October 2021 to June 2024.

Trial Details

This study is designed to provide information on whether the drug MDMA, combined with Cognitive Processing Therapy (CPT), is safe and helpful for people with Post Traumatic Stress Disorder (PTSD). PTSD is a serious debilitating disorder that negatively impacts a person's daily life, and can result in diminished functioning, fractured relationships, inability to maintain employment, substance abuse, depression, and suicide risk. People who suffer from PTSD relive their traumatic experience(s) through nightmares and flashbacks, have difficulty sleeping, and feel detached or estranged. CPT is a manualized treatment for PTSD, which has the participant make meaning of the traumatic event and its impact on their life. CPT is one of the treatments with the best evidence for the treatment of PTSD to date. Clients with PTSD discuss how they believe the trauma has impacted them, and the therapist teaches the client skills to challenge areas where they are "stuck" remembering the traumatic event. 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 CPT. Given the properties of MDMA, specifically in inducing the ability to stay with emotion and challenging cognitions, these effects are especially relevant to the mechanisms of CPT. This is a pilot study exploring CPT integrated with MDMA-assisted psychotherapy for treatment of PTSD. This study will enroll 10 participants diagnosed with PTSD, who will undergo a 2-month course of psychotherapy that includes CPT integrated with MDMA-assisted psychotherapy. Participants will go through CPT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Since this is the first time that CPT is being combined with individual MDMA-assisted psychotherapy for PTSD, the researchers are interested in gathering preliminary information about the blending of these two therapeutic approaches.

NCT Number NCT05067244

Data attribution

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