Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD

Completed

Conditions studied: PTSD

In brief

The goal of this long-term follow-up study is to measure how long effects of MDMA-assisted therapy last in participants with PTSD who were treated in a prior Phase 3 clinical trial of MDMA-assisted therapy. The main question it aims to answer is: Does MDMA-assisted therapy result in lasting reductions in PTSD symptoms? Participants who have received at least one dose of MDMA-assisted therapy will take a PTSD assessment at least six months after their last MDMA-assisted therapy session in the main study.

Key facts

Study ID

NCT05066282

Run by

Resilient Pharmaceuticals

People needed

186

Starts

2021-03-01

Expected to finish

2024-05-21

Last updated by the study team

2024-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrolled in a MAPS-sponsored study of MDMA-assisted therapy for the treatment of PTSD
• Have received Investigational Medicinal Product (IMP) in at least one Experimental Session in the main study
• Agree to be contacted by study team at least six months after the last Experimental Session in the main study to schedule and participate in LTFU visits

You may not qualify if…

• Are not able to give adequate informed consent
• Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation

Where it is running

• USCF — San Francisco, California, United States
• Dr. Simon Amar Inc — Montreal, Quebec, Canada
• Beer Yaakov Mental Health Center — Be’er Ya‘aqov, Israel
• Tel Hashomer — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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