PRESS RELEASE: Israel Embraces Research on MDMA-Assisted Therapy for PTSD
- First two Israeli participants complete treatment in Phase 3 clinical trial of MDMA-assisted psychotherapy for PTSD
- Israel is first national government to approve a Compassionate Use program for MDMA-assisted psychotherapy
- Israeli Ministry of Health represents the first national government to support therapeutic MDMA research ($500,000 in services)
- MAPS has raised $500,000 through individual donors and the Charles and Lynn Schusterman Family Foundation, and still seeks the final $200,000
Natalie Lyla Ginsberg, Director of Policy and Advocacy, MAPS
Today, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that the first two participants have completed treatment in MAPS’ Phase 3 clinical trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) in Israel.
The Phase 3 studies, taking place at two sites in Israel, are part of the international series of Phase 3 clinical trials sponsored by MAPS, intended to make MDMA-assisted psychotherapy a legal prescription treatment for PTSD under U.S. Food and Drug Administration (FDA) guidelines. The combined results of the Phase 3 trials, from 15 sites in the U.S., Canada, and Israel, are expected by the end of 2021.
“Preliminary research has shown that MDMA-assisted psychotherapy may be a profound way to help those who suffer greatly from traumatic experiences such as war or sexual assault,” said Dr. Keren Tzarfaty, Clinical Investigator, Training Supervisor, and Director of Israeli Projects and Collaborations with MAPS. “In the face of the perpetual violence in Israel and the surrounding region, this innovative heart-based treatment can transform suffering to wholeness.”
Over 10% of the Israeli population experiences PTSD, and this figure increases significantly in regions frequented by rocket attacks. Military service is compulsory, and most families in Israel have histories of trauma and persecution.
On February 3, 2019, Israel became the first government to approve a Compassionate Use program for MDMA-assisted psychotherapy for PTSD, which will allow 50 patients to receive the treatment outside of Phase 3 clinical trials. Patients with PTSD will be eligible to receive treatment at sites throughout Israel, including Rambam Medical Center in Haifa and psychiatric hospitals in Be’er Yaakov, Lev Hasharon, Be’er Sheva, and Sheba-Tel Hashomer.
The U.S. FDA followed Israel on December 20, 2019, when the agency agreed to an Expanded Access Program for MDMA-assisted psychotherapy for PTSD, also for 50 patients with PTSD.
“The Israeli Ministry of Health is constantly looking for new tools to get better results in psychological and psychiatric treatment,” says Bella Ben-Gershon, Director of Psychological Trauma for the Israeli Ministry of Health. “After seeing the very promising results of the completed MDMA-assisted psychotherapy research in Israel, we now believe that it is crucial to allow more citizens who suffer from PTSD to have access to this new treatment.”
Israel is also the first national government to financially support MDMA-assisted psychotherapy research. In February of 2019, the Israeli Ministry of Health granted $500,000 in medical and hospital services to MAPS in support of the Compassionate Use of MDMA-assisted psychotherapy for PTSD in Israel.
The Israeli Ministry of Health inspired the Charles and Lynn Schusterman Family Foundation, a major philanthropic organization that funds projects in the Jewish community and Israel, to contribute a generous grant to MAPS for the Israeli Compassionate Use program.
“A society is only as strong as how it cares for its most vulnerable communities,” says Stacy Schusterman, Chair of the Charles and Lynn Schusterman Family Foundation. “I am proud that Israel is leading the world in exploring new ways to support and treat people suffering from PTSD and psychiatric illnesses. The Compassionate Use program in Israel is an opportunity to help high-risk populations, including IDF soldiers who have served their country, whose mental health needs are often overlooked and underserved.”
MAPS estimates the total cost for treating all 50 patients in the Israeli compassionate use program at $1.2 million. With the contributions from the Ministry of Health and the Schusterman Family Foundation, together with additional gifts from Ron Beller, Anat Agmon, Moshe Tov Kreps, and Saggi Malachi, MAPS now has $200,000 left to raise for the Israeli program.
About MDMA-Assisted Therapy for PTSD
MDMA-assisted psychotherapy uses MDMA to improve the effectiveness of psychotherapy for PTSD. The treatment involves up to three administrations of MDMA in conjunction with psychotherapy in a controlled clinical setting as part of a course of psychotherapy. Once approved, patients will not be able to take the MDMA home—patients won’t be filling their prescriptions at their local pharmacy. Instead, MDMA-assisted psychotherapy treatment will only be available through a doctor and only in supervised therapeutic settings from certified clinicians.
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $75 million for psychedelic therapy and medical marijuana research and education. For more information, visit maps.org.
MAPS-sponsored clinical trials are conducted by the MAPS Public Benefit Corporation (MAPS PBC), a wholly owned subsidiary of MAPS formed in 2014 for the special purpose of balancing social benefits with income from legal sales of MDMA, other psychedelics, and marijuana. For more information, visit mapspublicbenefit.com.