MDMA-Assisted Psychotherapy for PTSD
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
Yes, participants must stop taking psychiatric medications, herbal supplements, and both prescription and nonprescription medications during the study.
What data supports the effectiveness of the drug MDMA in treating PTSD?
Research shows that MDMA-assisted therapy can significantly reduce PTSD symptoms, with one study reporting an 83% response rate in patients who had not improved with other treatments. Additionally, MDMA has been shown to enhance the effects of cognitive-behavioral conjoint therapy, improving PTSD symptoms, depression, sleep, and relationship satisfaction.12345
Is MDMA-assisted psychotherapy safe for humans?
MDMA-assisted psychotherapy has been studied for safety, and while it can increase blood pressure, heart rate, and body temperature, no serious adverse events were reported in a study with PTSD patients. Efforts to limit the conversion of MDMA to reactive metabolites may improve its safety profile.16789
How is MDMA-assisted psychotherapy different from other PTSD treatments?
MDMA-assisted psychotherapy is unique because it uses MDMA (commonly known as Ecstasy) to enhance the effectiveness of psychotherapy, helping patients process trauma more effectively. This approach is particularly promising for those with treatment-resistant PTSD, as it has shown significant improvements in symptoms compared to traditional therapies.1231011
Research Team
Paul Uy, MD
Principal Investigator
Remedy Institute
Anne Wagner, PhD
Principal Investigator
Remedy Institute
Eligibility Criteria
This trial is for adults with PTSD in the Greater Toronto Area who are willing to stop taking certain medications and agree to study rules. Participants must be healthy, able to swallow pills, proficient in English, and have a supportive person willing to join the study. Pregnant individuals or those at risk of becoming pregnant without contraception are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 7-week course of CBCT psychotherapy, with the MDMA-assisted group receiving two MDMA sessions as an adjunct to therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments including self-compassion, social support, PTSD symptoms, and relationship satisfaction
Crossover (optional)
Participants in the CBCT-only condition have the option to crossover and receive two MDMA sessions after follow-up
Treatment Details
Interventions
- CBCT
- CBCT RCT
- MDMA-Assisted CBCT for PTSD
CBCT is already approved in United States, European Union for the following indications:
- Post-Traumatic Stress Disorder (PTSD) - Investigational
- Post-Traumatic Stress Disorder (PTSD) - Investigational
Find a Clinic Near You
Who Is Running the Clinical Trial?
Remedy
Lead Sponsor
Remedy Institute
Collaborator