Training Protocol for MDMA-Assisted Psychotherapy Researchers (Open Label Phase 1 Study)

Principal Investigators: Michael Mithoefer, M.D. and Ann Mithoefer, B.S.N.
Location: Charleston, SC

This Therapist Training/ Phase 1 psychological effects protocol is a placebo-controlled, double-blind, randomized, cross-over study that allows MAPS to administer a single MDMA-assisted psychotherapy session to therapists as part of their training to conduct MAPS' MDMA/PTSD studies, while also conducting a series of evaluations of the psychological effects of MDMA administered to healthy volunteers in a therapeutic context.

This protocol is based in part on a precedent from the 1970s: Dr. Albert Kurland's LSD research team at Spring Grove Hospital in Maryland had FDA permission to administer LSD to help train nurses, attendants and others working with patients in clinical studies, and to mental health professionals (doctors, therapists, counselors, priests, rabbis) to help them better understand patients or congregants who had experienced LSD. Over 100 people received LSD in those training sessions. MAPS submitted letters to FDA from one of the researchers conducting that program, Johns Hopkins researcher William Richards, Ph.D., and from Daniel Helminiak, Ph.D., Ph.D., LPC, a participant in that program. Below you will find a partial list of documents that MAPS has submitted for this study. The list is not comprehensive because the IRB requested that we not include any proprietary documents and information.

On October 3, 2009, MAPS received a letter from the US FDA allowing the study to proceed. On December 21, 2009, we received IRB approval. On August 9, 2010, Dr. Mithoefer received his Schedule 1 license from the DEA to administer MDMA in this study.

Therapist Training Protocol/Phase 1 Psychological Effects: Amendment 2 approved by IRB 12/21/09 (PDF)

$265,000 needed to complete this study.
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Study Timeline

FDA IND application on June 22, 2009

• Submission Letter to FDA (PDF)
• IND form 1571 (PDF)
• IND form 1571 (PDF)
• Investigator's Brochure (PDF)
• Original Protocol (PDF)

FDA Submission of Amendment 1 on September 16, 2009

• Protocol Amendment 1 (PDF)
• MT-1 FDA approval letter (PDF)

IRB submission of Amendment 1 study materials on October 15, 2009

• Submission Letter to IRB (PDF)
• Principal Investigator Form 1572 (PDF)
• Protocol Amendment 1 (PDF)
• Principal Investigator CV (PDF)
• Co-Investigator CV (PDF)
• Investigator Medical License (PDF)
• MP-1 Preliminary Data (PDF)
• Study Rules (PDF)
• Subject Wallet Card (PDF)
• SUDS test (PDF)
• Interpersonal Closeness Test (PDF)
• IRB correspondence (PDF)

The IRB deferred approval of the study on October 26, 2009




We amended the study and re-submitted to the IRB on December 2, 2009

• IRB Submission Letter (PDF)
• MAPS Response to Deferral (PDF)
• Principal Investigator Form 1572 (PDF)
• Helminiak Letter of Support (PDF)
• Johnson Letter of Support (PDF)
• Richards Letter of Support (PDF)
• Protocol Amendment 2 (PDF)
• Case Report Forms (PDF)
• Template Therapy Manual (PDF)
• Johnson et. al. 2008 (PDF)
• IRB questions about study (PDF)
• IRB correspondence on December 14, 2009 (PDF)
• IRB conditional approval on December 16, 2009 (PDF)
• IRB correspondence on December 17, 2009 (PDF)
• IRB correspondence on December 21, 2009 (PDF)

The IRB officially approved the study on December 30, 2009

We submitted Amendment 2 for FDA Approval on December 30, 2009

• FDA Submission Letter (PDF)

This study has been fully approved.