Just as cannabis is gaining traction as a legitimate treatment option for military veterans, the U.S. Food and Drug Administration has given the “breakthrough therapy” designation to MDMA — the main chemical in the club drug Ecstasy — for treatment of post-traumatic stress disorder, or PTSD.
The move appears to pave the way for a Santa Cruz, Calif.-based advocacy group to conduct two trials of MDMA-assisted psychotherapy for patients with severe PTSD.
The nonprofit group Multidisciplinary Association for Psychedelic Studies plans to test out the strategy on 200 to 300 participants in clinical trials this spring.
“For the first time ever, psychedelic-assisted psychotherapy will be evaluated in (advanced) trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way,” said Rick Doblin, the group’s founder and executive director.
The FDA says it doesn’t disclose the names of drugs that receive “breakthrough therapy” designation. But if a researcher or drug company chooses to