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Phase 3 Trials to Test MDMA-Assisted Psychotherapy for PTSD

December 07, 2018

The Multidisciplinary Association for Psychedelic Studies (MAPS) is recruiting up to 150 participants for a phase 3 clinical trial investigating methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD).

This study—the first of two phase 3 trials—will compare the effects of 3 experimental sessions of MDMA-assisted psychotherapy with placebo. Over 12 weeks, participants will undergo 3 preparatory sessions, three experimental sessions, and nine integration sessions.

After an interim analysis of data, MAPS plans to conduct a second trial involving up to 150 additional participants. If both trials demonstrate significant efficacy and an acceptable safety profile of MDMA-assisted psychotherapy for PTSD, MAPS expects US Food and Drug Administrative approval of the treatment by 2021. FDA approval would allow MDMA-assisted psychotherapy by prescription only in supervised therapeutic settings from specially trained mental health providers.

BLOG: A Turning Point for Psychedelics?

In August 2017, the FDA granted Breakthrough Therapy designation to MDMA-assisted psychotherapy for PTSD. In doing so, the agency agreed to expedite its development and review, noting the intervention “may demonstrate substantial improvement over existing therapies.”

To be eligible for participation in the first phase 3 trial, volunteers must be 18 or older, be in good physical health, and have been diagnosed with PTSD. They must also live in or near one of the following locations: North Hollywood, California; Boulder, Colorado; Fort Collins, Colorado; New Orleans, Louisiana; or Mount Pleasant, South Carolina. Contact information for enrollment questions is available at the clinicaltrials.gov study page.

—Jolynn Tumolo

Reference

Participant screening begins in phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD [press release]. Santa Cruz, California: Multidisciplinary Association for Psychedelic Studies; November 29, 2018.

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