MDMA, more commonly known as Ecstacy, is one step closer to becoming a prescription drug.
The Food and Drug Administration granted permission this week for Phase 3 clinical trials of the drug. If they prove successful, the trials could turn MDMA into a treatment for post-traumatic stress disorder (PTSD).
“I’m cautious but hopeful,” said Dr. Charles R. Marmar, a PTSD researcher from New York University’s Langone School of Medicine who was not involved in the study.
“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.”
Marmar added that he has some concerns about the potential for MDMA abuse, however, stating: “It’s a feel-good drug, and we know people are prone to abuse it… Prolonged use can lead to serious damage to the brain.”
The Multidisciplinary Association for Psychedelic Studies, a nonprofit formed in 1985 to advocate for the legal medical use of drugs like MDMA, LSD and cannabis, will fund the Phase 3 research, which will include at least 230 patients. It was this same group that sponsored six Phase 2 studies treating 130 PTSD patients with MDMA.
Past studies have found success in treating PTSD with MDMA. Two South Carolina trials, for example, found a 56 percent decrease in the severity of PTSD symptoms among combat veterans, sexual assault victims and emergency responders after they were given three doses of MDMA.
Other research has found that the drug causes the brain to release hormones and neurotransmitters that evoke feelings of trust, love and well-being, while also curbing feelings of fear and negative emotional memories that can be overwhelming for PTSD patients.
Now, researchers are so optimistic about the potential of MDMA for PTSD treatment that they have applied for “breakthrough therapy status” with the Food and Drug Administration, which would quicken the approval process.
If approved, MDMA could be available through a prescription by 2021. Researchers have proposed it be used a limited number of times as part of a broader course of therapy, and always in the presence of trained psychotherapists.
The chemist Alexander Shulgin first discovered the healing potential in MDMA in the 1970s. As word spread, thousands of psychologists started administering what was then known as ‘Adam’ during therapy sessions, thinking it could be helpful for anxiety disorders. Before formal clinical trials began, however, the drug spread to bars and college campuses under the moniker of Ecstasy, leading the Drug Enforcement Administration to classify it as a Schedule 1 drug, banning all legal use.
h/t The New York Times.