RELIEF MAPS

MDMA is expected to get federal approval as a therapy treatment by 2024

BY WILL BRENDZA

Post Traumatic Stress Disorder (PTSD) affects roughly 5% of U.S. adults every year, according to the Centers for Disease Control (CDC). That number is likely low, as many who suffer from it go undiagnosed.

PTSD can be a debilitating condition. People get stuck in negative thought loops, feeling impulsive, sometimes explosive anger, and experiencing uncontrollable bouts of fear, guilt and shame. Many who suffer from PTSD lose interest in things they love, and those with severe cases often deal with long-term insomnia, anxiety, and paranoia.

The condition wasn’t officially recognized as a disorder until 1980, according to the National Center for PTSD. And six years later, Dr. Rick Doblin founded the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit organization dedicated to researching the healing potential of MDMA and other psychedelics. Doblin, having experimented with MDMA personally, recognized its unique potential as a therapy drug particularly for PTSD and other forms of trauma.

The research MAPS spearheaded, funded and otherwise supported in the decades since has helped move the needle on this substance. The latest MAPS-funded study, published in Nature Medicine, is a landmark piece of research that seems to justify everything the organization has worked toward over the last 37 years.

It was an 18-week, phase-three clinical trial of MDMA-assisted therapy for PTSD among a racially diverse set of 52 patients. Nearly 30% of participants suffered from moderate PTSD and the other 73.1% suffered from severe PTSD. More than 80% had a lifetime history of suicidal ideation. A “substantial portion of participants,” the researchers wrote, dealt with simultaneous conditions like depression, multiple sources of trauma and dissociative PTSD, which are all associated with treatment resistance. For the study, patients underwent three 90-minute sober sessions with a two-person therapy team for preparation. They were then randomized to receive either MDMA treatment or a placebo, with therapy once a month for three months. Every treatment period consisted of three eight-hour dosing sessions in conjunction with therapy with a MAPS-trained, state-licensed therapist.

The study’s results were clear.

“Notably, 45 of 52 (86.5%) participants treated with MDMA-AT achieved a clinically meaningful benefit, and 37 of 52 (71.2%) participants no longer met criteria for PTSD by study end,” the study reads. “Given the diverse population and degree of participant complexity, the replication of efficacy is particularly notable.”

This successful trial is a big step. The Food and Drug Administration (FDA) is currently considering MDMA for approval as a therapy drug, and this successful trial tips the scales heavily in MDMA’s favor because it backs up findings from previous MAPS-funded research.

“Thanks to the combined efforts of dozens of therapists, hundreds of participants who volunteered in MAPSsponsored trials, and many thousands of generous donors, MDMA-assisted therapy for PTSD is on track to be considered for approval by the FDA,” Doblin said in a press release about the Nature Medicine study.

Should MDMA get FDA approval, federal rescheduling, decriminalization, or outright legalization could be right around the corner. And Colorado is already locked in to legalize the substance in accordance.

In June 2022, Gov. Jared Polis signed a bill to legalize MDMA approvals pending federal approval.

MDMA induces prosocial feelings and softens responses to emotionally jolting and fearful stimuli. That makes it an ideal drug in conjunction with therapy for addressing deep-seated trauma. This study not only strongly shows that, but also proves the treatment is safe. No deaths, illnesses or other adverse effects were reported by any of the patients who received MDMA treatment.

Rick Doblin is ready for that moment. He’s been waiting for it since 1986.

“We hope that MDMA-assisted therapy for PTSD will be approved by the FDA next year, and that our open science, open books principle will inspire researchers to make this just the first of many psychedelic-assisted therapies to be validated through diligent research,” Doblin said.