FDA Approves First Study on Ecstasy-Assisted Therapy for Social Anxiety in Autistic Adults

The Raw Story
Eric W. Dolan

Originally appearing here.

The U.S. Federal Drug Administration in late April approved a study to examine whether the drug ecstasy could help autistic adults suffering from social anxiety. But the first-of-its-kind study still has some hurdles to jump over before it can begin.

“The study could start enrolling subjects in several months,” Brad Burge, the communications director at Multidisciplinary Association for Psychedelic Studies (MAPS), told Raw Story.

“However, it could be six months or more depending on how long the [Institutional Review Board] review process takes, how long it takes to set up the study site at the Harbor-UCLA Medical Center/Los Angeles Biomedical Research Institute, how long it takes to recruit subjects, and other factors. I estimate it will be four to eight months.”

Ecstasy, known scientifically as N-methyl-3,4-methylenedioxyamphetamine (MDMA), has the reputation of being a raver’s drug of choice. Due to its wanton use at electronic dance parties, MDMA was classified as a Schedule I controlled substance in 1985, a category reserved for dangerous drugs with no medical value.

But the drug has sparked interest among researchers who believe it could aid the process of psychotherapy. MDMA is known for its so-called “empathogenic effects” and has been found to reduce the fear of emotional harm while promoting feelings of social connection. The drug also produces a sense of euphoria and mild hallucinations. Though “street ecstasy” often contains dangerous contaminants, the researchers believe using pure MDMA in a controlled setting could help certain patients.

The study would investigate the safety and therapeutic potential of MDMA-assisted therapy for treating social anxiety in 12 autistic adults..

“This study will be the first time MDMA-assisted therapy has been explored in a clinical trial for social anxiety, and the first time it’s been explored to help adults on the autism spectrum,” Burge explained. “The many case reports collected by study co-investigator Alicia Danforth in her recently submitted doctoral dissertation indicate that it is likely to provide at least some benefit.”

“Existing research also shows that MDMA is safe enough for use in clinical research,” he added. “It’s a promising area of research, and indicates a real shift in how the public sees MDMA and other psychedelics.”

The FDA concluded on April 30 that the study was “reasonably safe to proceed as currently written,” but also offered some safety recommendations (PDF).

“The FDA will need to approve some small additional amendments, which we expect they will, then the protocol will be submitted for review by the Institutional Review (Ethics) Board at Harbor-UCLA/LA Biomed,” Burge told Raw Story. “These hurdles aren’t really obstacles, but they are necessary processes for conducting careful research.”

The study also faces another hurdle: money.

“Since no major foundations or government agencies have yet been willing to fund research into the possible therapeutic uses of MDMA or other psychedelics, we are seeking to raise the entire $256,000 we need for the study from individuals who understand the importance and potential of the research,” Burge said.

A similar MAPS-sponsored study, published last year in the peer-reviewed Journal of Psychopharmacology, found MDMA could help those suffering from post-traumatic stress disorder. One rape survivor told CNN the drug helped her cope with trauma by allowing her to “control where I was thinking and going, and look at things differently.”
The Raw Story reports on the U.S. Food and Drug Administration’s decision to approve MAPS’ new study that will explore the safety and therapeutic potential of MDMA-assisted therapy as a treatment for social anxiety adults on the autism spectrum. The study will take place at the Harbor-UCLA Medical Center/Los Angeles Biomedical Research Institute.