MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD) : Site 1
Principal Investigator: Michael Mithoefer, MD, with co-therapist Ann Mithoefer, BSN
Location: Charleston, SC (USA)

MAPS’ flagship Phase 2 pilot study is the first-ever protocol evaluating MDMA’s therapeutic applications in clinical trials conducted under an FDA IND. Like all of MAPS’ psychedelic-assisted psychotherapy studies, the protocol is randomized, double-blind and placebo-controlled. All twenty-one subjects with treatment-resistant PTSD, as a result of sexual abuse, crime, or war, have completed the experimental treatment. The study was completed in September 2008.

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• Dr. Mithoefer's MAPS-sponsored MDMA/PTSD protocol.
• The study will cost $1 Million; all of which has been raised.

Principal Investigator: Peter Oehen, MD, with co-therapist Verena Widmer, RN
Location: Solothurn (Switzerland)

Our Swiss MDMA/PTSD pilot study has full approval from an Ethics Committee (Swiss IRB equivalent) and SwissMedic (FDA equivalent). The protocol has also been submitted to and accepted by FDA under MAPS’ Investigational New Drug (IND) for MDMA. As a result, the study fits into MAPS’ initiative to develop MDMA
into a prescription medicine approved by both the FDA and the European Medicines’ Agency (EMEA). Over half of twelve subjects with treatment-resistant PTSD from any cause have undergone the experimental treatment.

Swiss MDMA/PTSD pilot study protocol

The study will cost $312,000; $65,000 is still needed.

Principal Investigator: Moshe Kotler, MD, with co-therapists Sergio Marchevsky, MD, Rakefet Rodrigez, MD, and Marina Kupchik
Location: Beer Yaakov Mental Health Center (Israel)

This study has full approval from the Israeli Ethics Committee and Ministry of Health. The experimental treatments are being conducted at Beer Yaakov Mental
Health Center, near Tel Aviv, under the direction of Principal Investigator Moshe Kotler, M.D., former chief psychiatrist of the Israeli Defense Forces and current Chair, Department of Psychiatry, Sackler School of Medicine, Tel Aviv University. The study will evaluate twelve subjects with treatment-resistant PTSD, mostly
war- or terrorism-related PTSD. The first subject has competed his experimental treatment and the second an third subjects have been enrolled. Like MAPS’ Swiss
MDMA/PTSD study, the protocol has been submitted to and accepted by FDA under MAPS’ IND for MDMA, and is part of MAPS’ initiative to develop MDMA into a prescription medicine approved by both the FDA and the EMEA. MAPS has sponsored three international scientific conferences in Israel on MDMA research to facilitate the protocol approval process.

Israeli MDMA/PTSD pilot study protocol

The study will cost $100,000; $60,000 is still needed.

Principal Investigator: Moshe Kotler, MD, with co-therapists Sergio Marchevsky, MD, Rakefet Rodrigez, MD, and Marina Kupchik
Location: Beer Yaakov Mental Health Center (Israel)

This study has full approval from the Israeli Ethics Committee and Ministry of Health. The experimental treatments are being conducted at Beer Yaakov Mental
Health Center, near Tel Aviv, under the direction of Principal Investigator Moshe Kotler, M.D., former chief psychiatrist of the Israeli Defense Forces and current Chair, Department of Psychiatry, Sackler School of Medicine, Tel Aviv University. The study will evaluate twelve subjects with treatment-resistant PTSD, mostly
war- or terrorism-related PTSD. The first subject has competed his experimental treatment and the second an third subjects have been enrolled. Like MAPS’ Swiss
MDMA/PTSD study, the protocol has been submitted to and accepted by FDA under MAPS’ IND for MDMA, and is part of MAPS’ initiative to develop MDMA into a prescription medicine approved by both the FDA and the EMEA. MAPS has sponsored three international scientific conferences in Israel on MDMA research to facilitate the protocol approval process.

Israeli MDMA/PTSD pilot study protocol

The study will cost $100,000; $60,000 is still needed.