SAN DIEGO—With much of the historical fear around psychedelics having dissipated, the founder of the Multidisciplinary Association for Psychedelic Studies (MAPS) sees current research as leading the field to the emergence of a new branch of psychotherapy.

Rick Doblin, PhD, updated attendees of Psych Congress 2019 on a Phase 3 research program that could result in US Food and Drug Administration (FDA) approval of MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) by the end of 2021.

MDMA, or 3,4-methylenedioxymethamphetamine, was seen as therapeutic before it was branded a party drug and declared illegal in the mid-1980s, but now Dr. Doblin says research evidence is demonstrating that the drug can help individuals process traumatic memories. Phase 2 research of MDMA-assisted psychotherapy that concluded in 2016 left participants feeling that “when they are no longer scared of these memories, they can work with them on their own,” he said.

More than two-thirds of patients receiving 3 sessions of MDMA-assisted psychotherapy no longer met criteria for PTSD in Phase 2 research that compared their outcomes to those of patients receiving therapy without MDMA.

The FDA has granted Breakthrough Therapy status to MDMA-assisted psychotherapy for PTSD, a treatment that Dr. Doblin envisions as being delivered by a pair of trained therapists in individual therapy sessions. He emphasized that the medication is not the treatment, and that a variety of potential therapeutic methods can be employed depending on what emerges from the patient in the sessions in which MDMA is administered.

If MDMA-assisted psychotherapy were to receive FDA approval for PTSD, the approval would be accompanied by a Risk Evaluation and Management Strategy (REMS) ensuring that only those trained in the MDMA-assisted psychotherapy could prescribe it, with delivery only under direct supervision in clinical settings. MDMA would not be a take-home treatment for PTSD.

More from Dr. Doblin: MDMA Moving Closer to Therapeutic Use

Dr. Doblin emphasized the enormous impact this tool ultimately could have on US military veterans, just over 1 million of whom were receiving disability payments based on PTSD as of September 2018. He said the Department of Veterans Affairs (VA) has contributed nothing financially to the drug development process, for political reasons, but that has not stopped some in the research community from continuing to try to convince VA leaders that this could represent a therapeutic breakthrough for a crippling and costly illness.

A parallel drug development process that is taking place in Europe has had a focus on using MDMA-assisted psychotherapy to reach the continent's burgeoning populations of refugees.

Taking profit out of the equation

Dr. Doblin, who says his own interest in mysticism and psychedelics emerged out of childhood trauma around historic events such as the Holocaust and the Cuban Missile Crisis, founded MAPS in 1986 to bring MDMA back into the mainstream. The nonprofit now invests in an associated for-profit public benefit corporation that is conducting the research and will be the entity selling the drug if it is approved.

Suddenly pharmaceutical companies have started to express interest in being involved, but MAPS has declined their overtures. “When we really needed you, you were nowhere,” has been Dr. Doblin's message, referring to the lack of industry interest at the time when MDMA was seen as a dangerous party drug.

The script has decidedly flipped since then, as evidenced by developments such as the FDA's recent indication that it will draft a guidance document for psychedelic research.

“We have tried not to optimize it financially,” Dr. Doblin said. He characterized much of the MAPS research team as “refugees from Big Pharma.”

The focus instead has been on training therapists in how to follow a regimen comprising three 8-hour sessions with overnight stays at the research facility followed by sessions the day after. “It's how it's integrated that's essential,” Dr. Doblin said.

MAPS' provider training offers therapists the option of being administered MDMA themselves, in order to understand better what the patient experiences in therapy. Eighty therapists have accepted that option so far, Dr. Doblin said.

—Gary Enos

Reference

“MDMA-assisted psychotherapy for PTSD: to Phase 3 and beyond.” Presented at Psych Congress 2019: San Diego, CA; October 3, 2019.