MDMA Successfully Treats PTSD in New Study, Scientists Eye FDA Approval

In the 1970s, MDMA was considered to be an anxiety-relieving drug. But when the United States government put it on the list of Schedule I drugs in 1985, it went underground, earning its present-day reputation as an illicit party drug. But now, the tides are turning once again for the synthetic drug, as a Lancet Psychiatry article showed on Thursday. It’s becoming indisputably clear that MDMA-assisted psychotherapy is beneficial for individuals with post-traumatic stress disorder.

The paper reveals the results of a U.S. Food and Drug Administration-regulated clinical trial in which police officers, firefighters, and veterans diagnosed with PTSD were treated with MDMA-assisted psychotherapy to great effect.

“These results are further evidence that MDMA, used just two times at monthly intervals, can make psychotherapy much more effective and better tolerated. I’m excited that Phase 3 trials will soon confirm whether this therapy can be approved for widespread use in a few years,” study co-author Dr. Michael Mithoefer of the Medical University of South Carolina said in a statement.

Each individual involved in the Phase 2 pilot study, which was sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), randomly received an oral dose of either 30 milligrams, 75 milligrams, or 125 milligrams of MDMA during two eight-hour sessions involving psychotherapy. By the end of the study, it was clear that higher doses — 75 and 125 milligrams — effectively reduced chronic PTSD symptoms and lowered total scores on the Clinician-Administered PTSD Scale.

The most encouraging part is, the effects appeared to last. One month after the second session, 68 percent of the full-dose MDMA group no longer qualified for a PTSD diagnosis. Comparably, only 29 percent of the low-dose MDMA group had the same result. When the team checked in on the study participants a year later, the positive results remained.

For both long-term advocates of therapeutic MDMA and the many people struggling to treat their PTSD, this is a landmark study.

Right now, patients diagnosed with PTSD have only two options for treatment: trauma-focused psychotherapies or with pharmacotherapy. Just two medications, sertraline and paroxetine, are currently approved by the FDA for PTSD, and off-label prescription drugs like antidepressants and benzodiazepines are commonly used even though their actual usefulness in treating PTSD hasn’t been confirmed. Psychotherapy has been shown to be the more effective option, but in trials, 60 to 72 percent of veterans who receive cognitive processing therapy and prolonged exposure therapy are still diagnosed with PTSD after treatment. These programs also have a high dropout rate, likely caused by adverse outcomes like worsening symptoms.

The new study also joins five other completed Phase 2 pilot studies on MDMA-assisted psychotherapy sponsored by MAPS and approved by the FDA. In the summer, the Phase 3 clinical trials will begin — a process that will include 200 to 300 participants receiving MDMA-assisted psychotherapy for PTSD across 16 sites in the United States, Canada, and Israel. If these trials are successful, and MDMA is declared to have a “significant efficacy and an acceptable safety profile,” it’s anticipated that the FDA will give its approval to the therapy by 2021.

There’s an urgent need for a new option — especially for the military personnel, veterans, and firefighters whose risk of PTSD and its tragic effects over a lifetime is much higher than that of the general population. “In addition to the severe psychological burden,” the study authors write, “chronic PTSD is associated with increased medical morbidity, occupational and relationship problems, decreased quality of life, overall decreased life satisfaction and happiness, and increased risk of suicide.”