MAPS Announces Progress in Two PTSD Studies

In the organization’s monthly newsletter, the Multidisciplinary Association for Psychedelic Studies (“MAPS”) announced two milestones in separately conducted clinical trials, both dedicated to the treatment of post-traumatic stress disorder (“PTSD”). This month, MAPS  received approval for the administration MDMA-assisted treatment in Israel amidst high PTSD rates within the country’s population. Their second study examines the use of smoked cannabis on the same condition, and while it has been ongoing the past decade, researchers formally submitted the findings for analysis this month.

Early February, the Israeli Ministry of Health issued the approval of expanded or compassionate use for medically distributed MDMA paired with psychotherapy sessions.¹ Fifty PTSD patients will be allowed to participate in the trials conducted at four medical centers throughout the country working alongside MAPS. Although Israeli law deems MDMA a hazardous substance,  recreational use is prohibited, and it’s official medical use is not fully developed, the approval of compassionate use provides an opportunity in the situation of a patients’ lack of effective alternatives.²

“The ministry is taking this seriously and with appropriate caution, an in-depth investigation has been carried out.” Bella Ben-Gershon director of mental trauma treatment at Israel’s Ministry of Health said to Haaretz Newspaper. “There is a considerable population in Israel of people suffering from PTSD that is resistant to other treatment.”³

Led by MAPS Principal Investigator Jana Yakirevitch, the clinical trials will begin the third phase of the study in mid-March 2019.⁴ “If we see positive results in the third stage and the FDA in fact approves the treatment in another two years, we want to have treatment centers and caregivers ready so we can start immediately,” MAPS representative in Israel, Dr. Keren Sarfati stated before emphasizing the need for effective treatment. “It’s so urgent because of the major suffering that post-trauma victims experience – suffering that can also lead to suicide – and at the moment, they have no remedy.”⁵

MAPS also stated that their MDMA-assisted psychotherapy is advancing further in discussions with the U.S. Food and Drug Administration (“FDA”). On February 15, MAPS and MAPS Public Benefit Corporation members spoke with FDA officials on the proposed procedures that would allow for an expanded access program similar to the one beginning in Israel. Although nothing was concretely settled, the organization claims to have provided information on expected timelines, the possibility of negative incidents, and training.

Multiple MDMA studies may be emerging, meanwhile, MAPS issued a press release on the completion of the first study dedicated to the use of cannabis as treatment for PTSD. The trial, which was sponsored by MAPS, was designed to evaluate smoked cannabis’s effectiveness in the treatment of 76 U.S. veterans with PTSD. “We are thrilled to finally be at the finish line of this nearly 10-year saga trying to get this crucial clinical trial completed,” Site Principal Investigator Sue Sisley, M.D., said thanking supporters of the research.⁶

According to Brad Burge, Director of Strategic Communications with MAPS, the results of the cannabis study are currently being reviewed and organized for the expected publication of the findings later this year.

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1. “Israel Approves Compassionate Use of MDMA-Assisted Psychotherapy for PTSD.” MAPS – Multidisciplinary Association for Psychedelic Studies, February 27, 2019.
2. Efrati, Ido. “Israel Approves Compassionate Use of MDMA to Treat PTSD.” Haaretz. February 11, 2019. Accessed February 28, 2019. https://www.haaretz.com/science-and-health/.premium-israel-s-health-ministry-approves-compassionate-use-of-mdma-to-treat-ptsd-1.6918710.
3. Efrati, Ido. “Israel Approves Compassionate Use of MDMA to Treat PTSD.”
4. “Israel Approves Compassionate Use of MDMA-Assisted Psychotherapy for PTSD.” MAPS – Multidisciplinary Association for Psychedelic Studies.
5. Efrati, Ido. “Israel Approves Compassionate Use of MDMA to Treat PTSD.”
6. MAPS. Strategic Communications. “Researchers Announce Completion of First Clinical Trial of Marijuana for PTSD in Veterans.” News release, February 20, 2019. MAPS. Accessed February 28, 2019. https://maps.org/news/media/7628-press-release-researchers-announce-completion-of-first-clinical-trial-of-marijuana-for-ptsd-in-veterans?pk_campaign=2019-02-Newsletter-February-Email&pk_kwd=intro-text-readthepressrelease-mmj.