Plans to conduct phase three clinical trials on MDMA are moving ahead after the U.S. Food and Drug Administration granted permission on Wednesday, according to Brad Burge, a spokesman for Multidisciplinary Association for Psychedelic Studies. The nonprofit group that studies therapy applications for psychedelic drugs and marijuana and will fund the new research.
Phase three clinical trials are the final stage necessary before the FDA approves the drug for public use, and the upcoming trial will seek to demonstrate whether MDMA can treat people struggling with flashbacks, traumatic memories and sleeping problems.
The New York Times notes that MDMA could be available as a PTSD treatment by 2021 if the clinical trial is successful and researchers’ application to speed up the approval process is granted. Burge said MAPS expects formal approval on trial designs to come in early 2017.
The trial could be an important step toward creating more treatment options for people with severe PTSD, which doesn’t respond respond to traditional therapy. Traditional treatments for PTSD include different kinds of talk therapy and antidepressant medication, but they don’t help everyone struggling with the condition.
MAPS has also sponsored early stage clinical trials that found MDMA is effective at helping reduce symptoms in people with chronic PTSD, and that these effects were long-lasting in most of the participants months after the original trial was over.
Tony Macie, a retired U.S. Army sergeant from Vermont, participated in those initial trials and wrote in a 2014 Reddit “Ask Me Anything” forum that the MDMA treatment helped him process his traumatic memories in peace. Prior to the trial, he said, he usually tried to suppress or ignore them:
After about an hour of just relaxing and being in the present is when memories started to come up. For me if I tried to push them away I would feel anxious, but if I dealt with it and processed the memory, I would have a wave of pleasure come over my body. I believe that the MDMA was showing me how to deal with my trauma and also that it is more beneficial for me to face trauma head on than to try and ignore it or suppress it. I had a lot of powerful [realizations] that day.
About seven to eight percent of the U.S. population will have PTSD at some point in their lives, according to the U.S. Department of Veterans Affairs. Among veterans, the percentage is even higher: Between 11 to 20 percent of those who served in Operations Iraqi Freedom or Enduring Freedom have PTSD in any given year, while the same can be said for 12 percent of Gulf War vets.
Currently, MDMA is classified as a Schedule I drug, which means the federal Drug Enforcement Administration considers it a substance with no medical use and a high potential for abuse. This category includes other illegal drugs like heroin, LSD and peyote. The National Institute on Drug Abuse notes that while MDMA may stimulate feelings of emotional warmth, empathy and decreased anxiety, it can also cause aggression, sleep disturbances, hyperthermia and organ failure. Overdosing on MDMA can lead to panic attacks, loss of consciousness and seizures.
Therapeutic uses for MDMA stretch back to the 1970s, as clinicians found it can improve communication with patients and give users new insight about their own problems.
CLARIFICATION: Language has been amended to reflect that the FDA gave permission for MAPS to move ahead with designing phase three clinical trials, though specifics will likely not be formally approved until next year.