U.S. Relapse News TImeline

U.S. Relapse Study: Second Subject Treated

On December 28, 2012, the second subject was treated in our ongoing relapse study of MDMA-assisted psychotherapy for PTSD in three subjects whose symptoms returned several years after participating in our completed U.S. proof of principle study.

U.S. Relapse Study: Follow-Up Interviews Completed for First and Second Subjects

On March 1, 2013, the first subject completed their final (one-year) follow-up interview in our ongoing relapse study of MDMA-assisted psychotherapy for PTSD in three subjects whose symptoms returned several years after participating in our completed U.S. proof of principle study. Also on March 1, the second subject completed their two-month follow-up interview.

U.S. Relapse Study: Third Subject Treated

On May 23, 2013, the third subject was treated in our ongoing relapse study of MDMA-assisted psychotherapy for PTSD in three subjects whose symptoms returned several years after participating in our completed U.S. proof of principle study.

U.S. Relapse Study: Third Subject Completes 2-Month Follow-Up Interview

On July 29, 2013, the third subject completed their two-month follow-up interview in our ongoing relapse study of MDMA-assisted psychotherapy for PTSD in three subjects whose symptoms returned several years after participating in our completed U.S. proof of principle study.

U.S. Relapse Study: First Subject Completes Follow-Up Evaluation after Successful Treatment

On April 27, 2012, the first subject completed their follow-up interview in our ongoing relapse study of MDMA-assisted psychotherapy for PTSD in two or three subjects whose symptoms returned several years after participating in our completed U.S. proof of principle study. The co-therapists for this study are Dr. Michael Mithoefer and Annie Mithoefer, B.S.N., who also conducted the original proof of principle study. The two-month follow-up evaluation revealed that a single additional open-label MDMA-assisted psychotherapy session was sufficient to reduce this subject’s score on the Clinician-Administered PTSD Scale (CAPS) below the diagnostic cutoff for PTSD. The results suggest that people who relapse after the initial series of treatments as a result of additional life stressors could benefit substantially from a single additional MDMA-assisted psychotherapy session.

U.S. Relapse Study: First Subject Treated

On February 22, 2012, the first subject was treated in our relapse study of MDMA-assisted psychotherapy for subjects whose PTSD symptoms returned after participating in our now-completed U.S. flagship study. The initial results are promising. While the long-term follow-up to this study found that the therapeutic benefits of MDMA-assisted psychotherapy were on average sustained over time, two subjects experienced a relapse. This study is an open-label proof-of-principle study, intended to determine whether a single additional MDMA-assisted psychotherapy session and four non-drug psychotherapy sessions can once again eliminate these subjects' PTSD symptoms. We are seeking $20,000 to complete this study.

U.S. Relapse Study: First Subject Screened

On January 20, 2012, the first of two subjects eligible for our relapse study of MDMA-assisted psychotherapy for PTSD was screened. This study will enroll two subjects whose PTSD symptoms eventually returned after participating in our U.S. flagship study of MDMA-assisted psychotherapy for PTSD, which was completed in July 2010. This is an open-label proof-of-principle study intended to test whether an additional MDMA-assisted psychotherapy session and several associated non-drug psychotherapy sessions can once again heal these subjects.

U.S. Relapse Study: MDMA-Assisted Psychotherapy Relapse Study Initiated

On January 16, 2012, the official study initiation took place for our upcoming relapse study of MDMA-assisted psychotherapy for PTSD. The first subject will be enrolled shortly thereafter. This study will enroll two subjects whose PTSD symptoms eventually returned after participating in our flagship study of MDMA-assisted psychotherapy for PTSD, which was completed in July 2010. This is an open-label proof-of-principle study intended to test whether an additional MDMA-assisted psychotherapy session and several associated non-drug psychotherapy sessions can once again free these subjects from a diagnosis of PTSD. This study is the first time we are offering an additional MDMA-assisted psychotherapy session after a considerable amount of time has passed (up to 64 months) after completing assessments following the initial therapy.

MDMA/PTSD U.S. 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 is limited to up to 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), and is currently in progress.

$55,000 needed to complete this study
Please consider donating today to help this study.

View the timeline for this study.