Summary: PsychCongress highlights the progress of MAPS-sponsored clinical trials of MDMA-assisted psychotherapy for PTSD and the upcoming featured session by MAPS Founder Rick Doblin, Ph.D., at Psych Congress Conference this October in San Diego, CA. The article takes note of a growing shift in public perception towards the therapeutic use of MDMA in conjunction with therapy, “It was a therapeutic drug before it was a party drug,” states Doblin.
Originally appearing here.
Approval of Drug-Assisted Therapy 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.
MDMA-assisted psychotherapy is being delivered in three 8-hour sessions spaced 1 month apart. Participants receive the treatment, stay overnight at the research facility, and attend a 90-minute session the next day to integrate what was learned the day before.
The first of the 3 sessions administers MDMA at a dose of 80 mg, followed by a 40-mg dose two hours later. The second session adjusts the two doses to 120 mg and 60 mg, respectively, and the third session features 1 of the 2 regimens based on participant response during the previous sessions. Dr. Doblin thinks the industry standard ultimately will be 2 sessions of MDMA-assisted psychotherapy.
The primary outcome in the Phase 3 research will be change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale (CAPS), which Doblin says is the only measure the FDA considers valid for evaluating a medication treatment for PTSD.
Doblin said that as of mid-June 2019, approximately 30 of the 200 anticipated participants in the Phase 3 research had been enrolled.
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The research team is currently negotiating for an expanded access designation that could allow more patients to access MDMA-assisted psychotherapy while Phase 3 proceeds, before any final approval is granted. “By the end of 2019, we should be able to open expanded access clinics,” Dr. Doblin said.
MAPS projects that MDMA-assisted psychotherapy could receive FDA approval by the end of 2021.
Dr. Doblin expects to address numerous post-approval implementation topics in his Psych Congress talk, including the Risk Evaluation and Mitigation Strategy (REMS) that would govern use of MDMA and the training requirements for those administering the medication-assisted therapy.
He said he has observed a change in thinking around psychedelics within a large segment of the medical profession.
“I see many young psychiatrists and residents wanting to get involved; they’re fascinated by this,” Dr. Doblin said. “There’s enormous burnout among psychiatrists, who are tired of just spending 15 minutes with a patient and constantly adjusting medication, just being an arm of the pharmaceutical industry. There is a yearning to move beyond that.”