MDMA-Assisted Psychotherapy for PTSD: Relapse Study
MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD) Relapse Study
An Open-Label Proof-of-Principle Study Testing the Use of an Additional MDMA-Assisted Psychotherapy Session in People who Relapsed after Participating in a Phase 2 Clinical Trial of MDMA-Assisted Psychotherapy to Treat Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)
Clinical Investigator: Michael Mithoefer, M.D. Location: Charleston, SC
This study enrolled three subjects whose PTSD symptoms returned after participating in our flagship Phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD. This relapse study will attempt to determine whether a single additional open-label MDMA-assisted psychotherapy session along with several non-drug psychotherapy sessions can be effective for once again enabling these subjects to be free of a diagnosis of PTSD.
This study has full approval from an Institutional Review Board (IRB), the U.S. Food and Drug Administration (FDA), and the U.S. Drug Enforcement Administration (DEA). All three subjects have been treated, and follow-up interviews are continuing to take place.