Bessel van der Kolk, MD is the Principal Investigator for a Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored phase 3 program evaluating the efficacy of MDMA-Assisted Psychotherapy for the Treatment of Moderate to Severe Posttraumatic Stress Disorder (PTSD). This multi-center study is designed to provide information on whether the drug MDMA combined with psychotherapy is safe and helpful for people with PTSD. Each volunteer is assigned at random (like flipping a coin) to get either MDMA with psychotherapy or psychotherapy with a placebo. Volunteers will have a 50/50 chance of being assigned to either group.
MDMA-assisted psychotherapy for PTSD is currently in Phase 3 clinical trials in the US, Canada, and Israel. This means that previous studies have been completed that suggested MDMA-assisted psychotherapy is safe and effective for treating PTSD. The Phase 3 clinical trials will enroll more participants to determine if the previous study results were correct and collect more data on the risks and benefits of the drug.
On August 16, 2017, the FDA granted Breakthrough Therapy Designation to MDMA for the treatment of PTSD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies.