MDMA/PTSD U.S. Study (Veterans of War)

A Randomized Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 24 Veterans with Chronic Posttraumatic Stress Disorder (PTSD)

Principal Investigator: Michael Mithoefer, M.D., with co-therapist Annie Mithoefer, B.S.N.
Location: Charleston, SC (USA)

This pilot Phase 2 study is examining the safety and efficacy of MDMA-assisted psychotherapy in 24 veterans, firefighter, and police officers with service-related PTSD. We are seeking equal numbers of male and female subjects. This protocol is randomized and triple-blind. All subjects will receive weekly non-drug psychotherapy and three experimental day-long therapy sessions, scheduled three to five weeks apart. We are testing three different doses of MDMA to determine whether this design will result in a successful blind, with subjects, therapists, and the independent rater being uncertain about which subject received which dose. 12 subjects will receive a full 125 mg dose followed by a 62.5 mg supplemental dose; six subjects will receive an active dose of 75 mg followed by a supplemental 37.5 mg dose; and six subjects will receive an active placebo dose of 30 mg followed by a supplemental 15 mg dose.

The findings of this study in veterans with war-related trauma will be compared to the findings from our flagship pilot study of MDMA-assisted psychotherapy for PTSD, which consisted primarily of women survivors of sexual abuse and assault. Previous studies suggest that war-related PTSD may be more prevalent and harder to cure than PTSD caused by other types of trauma, and this study may help establish the relationship between trauma etiology and treatment efficacy.

We are currently seeking research participants for this study. Please visit our participate in research page for more information.

Download the protocol for this study.

We still need to raise approximately $7,500 out of the $595,000 needed for this study. Please consider donating today to make sure this study is completed.

View the timeline for this study.

On December 23, 2009, we submitted our Investigational New Drug (IND) application to the FDA.

• MDMA/PTSD in U.S. War Veterans Protocol submitted to the FDA on December 23, 2009
• Submission Letter to FDA
• IND form 1571
• Principal Investigator form 1572
• Investigator's Brochure
• Original Protocol Part 1, Part 2, Part 3
• Curriculum vitae of Principal Investigator
• Curriculum vitae of Co-Investigator
• Curriculum vitae of Co-Investigator
• Template Informed Consent
• Draft Case Report Forms

On February 1, 2010, our FDA IND application was approved with no changes required.

On April 1, 2010, the FDA accepted the first amendment to our Veterans of War Protocol.

• Cover letter to the FDA
• IRB Approval Letter
• Summary of Changes
• FDA Forms

On August 27, 2010, the Drug Enforcement Administration (DEA) informed Clinical Investigator Michael Mithoefer, M.D., that it had approved his Schedule 1 license.

On August 31, 2010, we submitted the second protocol amendment to the IRB.

On February 10, 2012, we submitted the third protocol amendment to the FDA.