The Future of MDMA as Possible Treatment for PTSD

Rick Doblin, PhD, Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS), Belmont, Massachusetts, discussed the possible future treatment landscape for psychedelics under legalization during a virtual presentation at Sana Symposium.

MDMA (3,4-Methyl​enedioxy​methamphetamine), a psychoactive drug, was criminalized in 1985 by the United States Drug Enforcement Administration (DEA). Dr Doblin founded MAPS as a non-profit pharmaceutical company in 1986 with the goal of keeping therapeutic uses of MDMA legal.

Dr Doblin and co-researchers have completed a phase 3 study on the effects of MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD), which was published in Nature Medicine in May of 2021. Results showed that MDMA paired with talk therapy could be an effective treatment for severe PTSD.

“MDMA is a tool. It helps people build the therapeutic alliance, reduces fear, etc., and it can be used in the context of many different therapeutic approaches,” Dr Doblin stated.

About 2/3 of patients receiving MDMA in addition to therapy for 3 sessions no longer qualified for a PSTD diagnosis, according to the study.

Dr Doblin described the therapeutic approach as “inner-directed therapy,” which focuses on providing patients with support to access their “inner healing intelligence.”

In May of 2022, interim analysis will be completed on a second phase 3 study, which will be conducted in October of 2022.

“If results are even close to as good as our first phase three study, we will submit to the FDA (Food and Drug Administration). We expect FDA approval in the third quarter of 2023, DEA rescheduling in the fourth quarter, and marketing begins at the end of 2023,” Dr Doblin said.

Post-approval risk evaluation and mitigation strategies include administration limited to certified clinics, ability to prescript being limited to certified therapists trained by the sponsor, defined safety screenings, and centralized pharmacy.

“This is the key way that we’re going to be controlling post-approval, is that it is going to be trained people administering it under direct supervision,” he said.

Following potential FDA approval in 2023, Dr Doblin said he believes this psychedelic therapy will be legal under licensed legalization by 2035. Through licensed legalization, patients will have a license to use the drug for therapeutic purposes, which can be taken away for misbehavior.

There will be a parental override, similar to alcohol laws in some states, allowing parents of minors to decide if minors can use psychedelic therapies under their care.

Dr Doblin and fellow researchers at MAPs are hoping to reach 1 million MDMA sessions in a 6 year period following potential approval in 2023. They hope to train 25,000 therapists to administer these treatment options and treat 500,000 patients using a 2-session model.

“We are hoping potentially even more than 1 million sessions in this 6-years after approval,” Dr Doblin concluded. “We think, then, that this education of therapists, and the training, and the treatments through the clinics will also have public education on the people…and will move to this kind of process of drug policy reform and medicalization.” 

Reference

Doblin R. A Look to the future: exploring a post-legalization landscape for psychedelics. Presented at: SANA Symposium; September 17-19, 2021; Virtual.