Summary: Futurism reports on open enrollment of MAPS-sponsored Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD, highlighting the five out of fourteen sites in the U.S. that have started screening participants for enrollment. The data from Phase 3 trials will help determine if MDMA-assisted psychotherapy will be made into a legal treatment option for PTSD, for which limited treatments are currently available. MAPS Founder Rick Doblin, Ph.D., further explains, “There are a lot of people that have post-traumatic stress disorder for whom the currently available medications and psychotherapies don’t work.”
Originally appearing here.
MDMA could soon move out of the nightclub and into the doctor’s office.
On Thursday, the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit focused on researching the medical benefits of psychedelics and marijuana, announced it was ready to begin recruiting volunteers for Phase 3 clinical trials to test whether MDMA , a drug commonly known as ecstasy, could be an effective treatment for post-traumatic stress disorder (PTSD).
“[T]here are a lot of people that have post-traumatic stress disorder for whom the currently available medications and psychotherapies don’t work,” MAPS founder Rick Doblin explained in a video describing the nonprofit’s research.
MAPS also announced the five sites where it is currently enrolling volunteers for these trials: North Hollywood, California; Boulder, Colorado; Fort Collins, Colorado; New Orleans, Louisiana; and Mount Pleasant, South Carolina.
According to a MAPS press release, the organization plans to enroll between 100 and 150 adult volunteers with severe PTSD in the trial. These volunteers will need to live near one of 14 locations in total: the five listed above and nine others throughout the U.S., Canada, and Israel, where enrollment will begin soon.
Each volunteer will undergo a 12-week-long treatment plan consisting of 15 sessions, including three experimental sessions during which some volunteers will undergo MDMA-assisted psychotherapy while others will receive a placebo.
The researchers will then review the data from this Phase 3 clinical trial before beginning a second Phase 3 trial, which will also enroll 100 to 150 participants.
Phase 3 is the final trial stage before the U.S. Food and Drug Administration can clear a drug for medical use, so if these trials produce positive results, the next step could be FDA approval of an MDMA-assisted psychotherapy treatment for PTSD.
MAPS think that approval could happen as soon as 2021 — and if it does, it could be life-changing for the estimated nine to 10 million Americans with PTSD.
“MDMA-assisted psychotherapy is unique among trauma treatments,” added Gregory Wells, a principal investigator on the trial. “It allows the participants or the patients to access their traumas in a way that they aren’t overwhelmed by their past experiences. They can address their fear around their trauma.”