The Government Gets One Step Closer to Approving MDMA to Treat PTSD
The third phase of the clinical trial will include 230 patients.
Image: Johns Hopkins/WIkimedia
Few weeks go by when we don't hear of the various possibilities of using psychedelics as treatment—whether it's ayahuasca or LSD. Now the government has brought us one step closer to legalizing psychedelics as medicine.
On Tuesday, the Multidisciplinary Association for Psychedelic Studies (MAPS) received approval from the FDA to go forward on a study looking into MDMA, the main chemical in ecstasy, for the treatment of PTSD. Having already completed the first two necessary phases of FDA-approved research, the up and coming third and final phase of the study will be the last major step before MDMA can become available to qualifying patients. MAPS' goal is to have MDMA approved by the FDA as a legal treatment for PTSD by 2021.
Brad Burge, MAPS director of communications and marketing, explained to Motherboard how MDMA works to reduce PTSD symptoms: It enhances activity in the prefrontal cortex, enhancing memory and awareness, it reduces activity in the amygdala, the part of the brain that regulates fear and hyperarousal, and it causes the release of hormones, including oxytocin and prolactin, increasing trust and empathy between the participant and the therapists. By reducing fear through the amygdala, a mass of grey matter in the brain that impacts emotions, MDMA allows participants to revisit and reprocess trauma, adds Natalie Ginsberg, policy and advocacy manager at MAPS.
The third phase of MAPS' MDMA for PTSD research will begin next year, probably by June 2017, and will last three to four years, Burge said. They'll enroll at least 230 participants, or as many as 400, depending on whether they do one or two Phase 3 trials, he said. The greatest challenge, he added, will be funding, since MAPS will need to raise about $20 million to complete these trials over the next four years. "Phase 3 is much larger than Phase 2 trials, and is intended to obtain data on treatment effectiveness, as well as safety in a larger population than was seen in Phase 2 trials."
The Phase 2 trials, lasting from 2000 through 2016, involved 107 participants. In past research, participants with PTSD included veterans, survivors of sexual assault, police and firefighters. MAPS' Phase 2 trial, 130 patients were treated over the course of six studies. On average, patients had suffered from PTSD for about 17 years. At the end of the study, two thirds of patients no longer qualified for having PTSD, while after three doses of MDMA in assisted psychotherapy, their symptoms diminished by an average of 56 percent.
According to PTSD researcher Dr. Charles Marmar, head of psychiatry at New York University's Langone School of Medicine, who is not involved in MAPS' study, even the best therapies currently available don't help 30 to 40 percent of patients. "So we need more options," he told the New York Times. And Rachel Hope, a patient who underwent a 2012 MDMA study to treat trauma from childhood sex abuse, told CNN it allowed her to "rewire" her brain.
That said, the experience of therapy can be hard. "It's painful, Mithoefer told Motherboard in the past. "A few people on the first day have said they don't know why it's called ecstasy."
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