It’s been over a year since Phase 2 trials of MDMA in the treatment of PTSD began, but now the FDA has formally given permission for a large-scale, Phase 3 trial period with at least 230 patients. These clinical trials are the final step before MDMA could potentially be approved as a prescription drug.

The studies and trials are funded by Multidisciplinary Association for Psychedelic Studies (MAPS), a small nonprofit created in 1986 to advocate the legal medical use of MDMA, LSD, marijuana and other banned drugs. So far, MAPS has shown exceptional success with the trials.

“I’m cautious but hopeful,” Dr. Charles R. Marmar, the head of psychiatry at New York University’s Langone School of Medicine, a leading PTSD researcher who was not involved in the study, told the New York Times. “If they can keep getting good results, it will be of great use. PTSD can be very hard to treat. Our best therapies right now don’t help 30 to 40 percent of people. So we need more options.”

He offered a caveat, that prolonged use can be harmful to the brain. However, the conditions for entering the trials and the methods of treatment are all closely monitored and are made to avoid abuse at all costs.

Other physicians and researchers are more worried about the potential harmful effects of such a trial.

Andrew Parrott, a psychologist at Swansea University in Wales who has studied the brains of chronic Ecstasy users, says that these trials could send the wrong message, that using drugs “will help you solve your problems.”

The treatment process is not only with MDMA. According to the plan for the trials in Phase 2, patients attended twelve weeks of psychotherpy. Of those sessions, there were three eight-hour sessions in which they took MDMA. “During the sessions, they lay on a futon amid candles and fresh flowers, listening to soothing music,” writes the NY Times.

Even the criteria for joining the trials is quite restrictive. Phase 2 trials were only open to those who had absolutely no other alternative – those who had been suffering for multiple years, those who had tried anti-psychotics or anti-depressants, those who had literally nowhere else to go. These same type of individuals were in the trials mentioned above, and still, 83% were found to no longer meet the symptomatic conditions for PTSD.

MAPS has thus applied for “breakthrough therapy” status with the Food and Drug Administration, which would speed up the approval process. If approved, the drug could be available by 2021.

 

via NY Times