DENVER (KDVR) – MDMA-assisted therapy could be on track to be approved at the federal level in 2024, and if that happens, Colorado already has a law allowing its use.
A study published Thursday found that the drug 3,4-methylenedioxymethamphetamine, also known as ecstasy or molly, can reduce symptoms of post-traumatic stress disorder when combined with psychotherapy.
The study was sponsored by the Multidisciplinary Association for Psychedelic Studies, which advocates for the development of psychedelic medicine. The group hopes to apply for approval from the Food and Drug Administration later this year, with hopes that the MDMA-assisted therapy will gain approval next year.
“It is the first innovation in the treatment of PTSD in more than two decades. And it’s important because I think it will open up other innovations as well,” said Amy Emerson, executive director of MAPS Public Benefit Corporation, which administered the study.
Under a bipartisan Colorado law passed more than a year ago, FDA approval would be the first step in allowing MDMA in the state.
Legal MDMA provided under existing Colorado law
Colorado has been at the forefront of drug decriminalization in the United States, first with cannabis, through a voter-approved constitutional amendment. Legal recreational sales began in 2014.
Last November, Colorado voters decriminalized psilocybin mushrooms and approved a legal framework for offering the psychedelic in a therapeutic setting. The same initiative also decriminalized mescaline, ibogaine, and dimethyltryptamine (or DMT for short). Under the law, those psychedelics could also be considered for legal therapeutic use in the future.
But months before the vote on psychedelics, in June 2022, Governor Jared Polis signed a bill that advances the legality of MDMA in Colorado.
If the FDA approves a prescription drug that includes MDMA and it is removed or exempted from its classification as a Schedule I narcotic under the Controlled Substances Act, the drug would be permitted in the state.
That includes prescribing, dispensing, transporting, possessing and using what would be a new prescription drug in Colorado by any person who is legally authorized to do so, according to the bill summary.
The bill’s main sponsors in the House were Republican Patrick Neville and Democrat David Ortiz. Leading sponsors in the Senate included Republican Minority Leader John Cooke and Democrat Joann Ginal.
MDMA studied for post-traumatic stress disorder therapy
Earlier this year, Australia became the first country to allow psychiatrists to prescribe MDMA and psilocybin, the psychoactive ingredient in psychedelic mushrooms. Drugs are gaining greater cultural acceptance in the United States, in part thanks to the efforts of MAPS.
For the new MAPS study, researchers measured symptoms in 104 people with PTSD who were randomly assigned to receive MDMA or a sham pill for 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.
At the end of the study, 72 percent of people in the MDMA group no longer met the diagnostic criteria for PTSD, compared to about 48 percent in the placebo group.
MDMA is currently classified as Schedule 1, on par with heroin, and is considered to have “no currently accepted medical use and a high potential for abuse.”
The Associated Press contributed to this report.