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MDMA Moving Closer to Therapeutic Use

August 14, 2019

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.

Also at Psych Congress: The Current and Future Roles of Genetics in Psychiatry

“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.


Submitted byDrSook on September 30, 2019

Frustration with traditional pharmacology's disappointing results long term surely makes fast-acting dissociative, stimulant and hallucinogenic substances compelling to naive clinicians. Patients' suffering has always motivated the implementation of bold and novel treatments- but Psychiatry has a sad history of missteps: insulin coma, bilateral ECT, prefrontal lobotomy, cingulatomy, rapid neuroleptization, high dose DA blockade, polypharmacy (often with Big Pharma corruption of clinical trials and 'thought leaders') and the over sale of SSRIs. The assiduous search for individualized treatment- skilled psychotherapies and efficacious medication - has also been inhibited by insurers and HMOs that seek cheap one-size-fits-all approaches. The problem with MDMA (a stimulant), ketamione (a dissociative agent) and hallucinogens is patient selection and long term use is undeveloped. The claim to assist psychotherapy has not generated anything like a serious theory/technique for subsequent psychological work. 'Kicking down the door' of defensive structures built up for self-protection is a radically different entry into mental pain.
The hubris of this movement is now encouraged as glutamate gives Big Pharma a new angle; short therapies appeal to insurers. This may also produce high fees for treaters. Meanwhile, Vets with PTSD can be followed for 5 years before extending these approaches to the general population. As with SSRIs, the long term problems were not recognized for a decade!

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