Participant Screening Begins in Phase 3 Clinical Trials of MDMA-Assisted Psychotherapy for PTSD

Dec 6, 2018 | Press Releases

Five sites in California, Colorado, Louisiana, and South Carolina now open for enrollment inquiries, with more opening soon. All-new video—Breakthrough for Psychedelic Medicine—explains how individuals can support non-profit research for PTSD and other mental health conditions

CONTACT:
Brad Burge, Director of Strategic Communications, MAPS
brad@maps.org

Today, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that recruitment has begun for its much-anticipated multi-site Phase 3 clinical trials of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD).

The research will take place at 14 sites (listed below) and enroll 100-150 volunteers with severe PTSD. Volunteers must be at least 18 years old and have been diagnosed with PTSD, and must be in good physical health to participate.

This study will compare the effects of three experimental sessions of MDMA-assisted psychotherapy versus placebo. The treatments will take place during an approximately 12-week treatment period, which includes three preparatory sessions, three experimental sessions, and nine integration sessions.

This will be the first of two Phase 3 trials of MDMA-assisted psychotherapy for PTSD conducted under U.S. Food and Drug Administration (FDA) guidelines. The second trial will take place after an interim analysis of the data from the first trial, and will enroll an additional 100-150 participants. European trials are planned to start in 2019.

If the Phase 3 trials demonstrate significant efficacy and an acceptable safety profile, FDA approval is expected by 2021. Once approved, MDMA-assisted psychotherapy would only be available by prescription in supervised therapeutic settings from specially trained mental health providers.

The following sites are now accepting enrollment inquiries from individuals living in or near the following locations: North Hollywood, California; Boulder, Colorado; Fort Collins, Colorado; New Orleans, Louisiana; and Mount Pleasant, South Carolina. Contact information for enrollment inquiries is available at clinicaltrials.gov.

Additional sites to start enrollment soon include: San Francisco Insight and Integration Center (San Francisco, Calif.); University of California, San Francisco; Trauma Research Foundation (Boston, Mass.); New York University; Affective Care (New York, NY); Providence Health Center (Vancouver, BC, Canada); Dr. Simon Amar LLC (Montreal, Québec, Canada); Be’er Ya’akov Mental Health Center (Israel); and Sheba/Tel Hashomer (Israel).

In August 2017, based on the results of MAPS’ Phase 2 trials, the FDA granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD, acknowledging that it “may demonstrate substantial improvement over existing therapies” and agreeing to expedite its development and review.

This month, MAPS released the all-new Breakthrough for Psychedelic Medicine video to explain how researchers are making evidence-based treatments for PTSD and other mental health conditions. Watch the video now at maps.org or on YouTube.

About MAPS

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 $70 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 (MPBC), 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 mapsbcorp.com.

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MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a 501(c)(3) non-profit research and educational organization.