Approval of Drug-Assisted Psychotherapy for PTSD Would Counter Party Drug Image
Arguments about the benefits and risks of 3,4-methylenedioxymethamphetamine (MDMA) as a therapeutic drug have played out for decades like an intellectual game of ping pong, with no apparent resolution in sight. But a leading researcher on psychedelics now sees late 2021 as the target date for MDMA to complete the transition from perceived party drug to legitimate prescription medication.
Phase 3 research into MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) began last November, and Rick Doblin, PhD, is no longer seeing the kind of opposition that has stalled progress toward a therapeutic indication for MDMA in the past.
“We’re focusing on PTSD, with a lot of PTSD being suffered by veterans,” said Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS). “The data show that 20 veterans a day are committing suicide. The SSRIs don’t work well with this group. There is an enormous unmet need, and these people are highly valued.”
At this year’s Psych Congress, Dr. Doblin will present a featured session on the drug development process for MDMA and practical considerations for integrating the medication into behavioral health treatment. The US Food and Drug Administration (FDA)’s granting of Breakthrough Therapy status to MDMA-assisted psychotherapy has accelerated a process toward approval that began with exploratory studies nearly 2 decades ago.
Researchers such as Dr. Doblin who believe MDMA has multiple applications in both medical care and personal growth have seen their cause stymied at several turns over the years, starting in 1985 when the US Drug Enforcement Administration (DEA) moved to declare the drug illegal on an emergency basis. Theories about its therapeutic potential in the 1970s had given way by then to concerns about young people’s use of MDMA (street name: Ecstasy) to fuel all-night parties.
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“It was a therapeutic drug before it was a party drug,” said Dr. Doblin, who has sought in his career to develop legal contexts for the beneficial use of psychedelics and marijuana, mainly as medicine but also for personal growth in mainly healthy populations. MDMA has been used in the past in couples therapy and to relieve cancer patients’ anxiety about death, he said.
When the National Institute on Drug Abuse (NIDA) indicated in the 1990s that it supported the resumption of human research into MDMA’s therapeutic potential, few believed any entity would be able to step in where pharmaceutical companies wouldn’t because of a lack of patent protection for a drug that was invented more than 100 years ago. “They didn’t count on MAPS,” Dr. Doblin said.
He said the research has consistently sought to test the drug in some of the most challenging patient populations. Phase 2 study participants had been diagnosed with PTSD for an average of 19 years, he noted.In the Phase 3 research, for which sponsors have raised around $34 million in donations, a male/female team consisting of a psychiatrist or other licensed practitioner and a student is working with each participant with PTSD. “It is a well-functioning team that mimics the well-functioning parents that a lot of these patients didn’t have,” Dr. Doblin said.