DENVER (KDVR) — MDMA-assisted therapy could be on track for federal approval in 2024, and if that happens, Colorado already has a law on the books to allow its use.
A study published Thursday found the drug 3,4-methylenedioxymethamphetamine — also known as ecstasy or molly — can reduce symptoms of post-traumatic stress disorder when combined with talk therapy.
The study was sponsored by the Multidisciplinary Association for Psychedelic Studies, which advocates for the development of psychedelic medicine. The group expects to file for Food and Drug Administration approval later this year, with hopes that MDMA-assisted therapy will earn approval next year.
“It’s the first innovation in PTSD treatment in more than two decades. And it’s significant because I think it will also open up other innovation,” said Amy Emerson, CEO of MAPS Public Benefit Corporation, which administered the study.
According to a bipartisan Colorado law passed over a year ago, FDA approval would be the first step to allowing MDMA in the state.
Legal MDMA anticipated under existing Colorado law
Colorado has been at the forefront of U.S. drug decriminalization — first with cannabis, through a voter-approved constitutional amendment. Legal recreational sales started in 2014.
Last November, Colorado voters decriminalized psilocybin mushrooms and approved a legal framework to offer the psychedelic in a therapeutic setting. The same initiative also decriminalized mescaline, ibogaine and dimethyltryptamine — or DMT for short. Under the law, those psychedelics also could be considered for legal therapeutic use in the future.
But months before the psychedelics vote, in June 2022, Gov. Jared Polis signed a bill that anticipates legal MDMA in Colorado.
If the FDA approves a prescription medicine that includes MDMA, and it’s removed or exempted from its Schedule I narcotics classification under the Controlled Substances Act, the drug would be allowed in the state.
That includes prescribing, dispensing, transporting, possessing and using what would be a new prescription drug in Colorado by anyone who’s legally allowed to do so, according to the bill summary.
The bill’s primary sponsors in the House were Republican Patrick Neville and Democrat David Ortiz. Lead sponsors in the Senate included Republican Minority Leader John Cooke and Democrat Joann Ginal.
MDMA studied for PTSD therapy
Earlier this year, Australia became the first country to allow psychiatrists to prescribe MDMA and psilocybin, the psychoactive ingredient in psychedelic mushrooms. The drugs are gaining wider cultural acceptance in the U.S. in part because of efforts by MAPS.
For the new MAPS study, researchers measured symptoms in 104 people with PTSD who were randomly assigned to get either MDMA or a dummy pill during three sessions, one month apart. Both groups received talk therapy.
After treatment, 86% of the MDMA group improved on a standard PTSD assessment compared to 69% of the placebo group. The assessment measures symptoms such as nightmares, flashbacks and insomnia.
By the study’s end, 72% of people in the MDMA group no longer met the diagnostic criteria for PTSD, compared to about 48% of the placebo group.
MDMA is currently classified as Schedule 1, on par with heroin and deemed to have “no currently accepted medical use and a high potential for abuse.”
The Associated Press contributed to this report.