Summary: Pharmacy Times examines the benefits and risks of using MDMA as an adjunct to psychotherapy for treating posttraumatic stress disorder (PTSD) in a clinical research setting. The article highlights the U.S. Food and Drug Administration (FDA)’s for allowing MAPS to move forward with Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. “For groups advocating for MDMA’s legitimacy as a medical treatment, such as the Multidisciplinary Association for Psychedelic Studies (MAPS), this represents a significant step forward in a lengthy journey,” reports Eric Roath, PharmD, of Pharmacy Times.
Originally appearing here.
A recent report in the New York Times highlights “ New Trials for Ecstasy as Relief for PTSD Patients.” And the Internet is now buzzing about how methylenedioxymethamphetamine (MDMA; also known as ecstasy) could become legal in the coming years. For groups advocating for MDMA’s legitimacy as a medical treatment, such as the Multidisciplinary Association for Psychedelic Studies (MAPS), this represents a significant step forward in a lengthy journey. For some of us, however, this seems to have come out of nowhere. To gain a little perspective on this, I did some quick Internet research to see exactly how new this somewhat provocative movement really is. As it turns out, this discussion has been going on for a while.
First, let’s look take a closer look at MAPS. According to their website, MAPS was founded in 1986. The nonprofit organization serves as a “research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.” The organization’s November bulletin announced the highly anticipated meeting with the FDA, which occurred on November 29, 2016, to move into Phase 3 trials of MDMA-assisted psychotherapy for PTSD. The bulletin cites promising results from their Phase 2 trials which took place earlier this year.
Information regarding a Phase 2 study, which is available through ClinicalTrials.gov, describes a unique approach that uses MDMA to augment cognitive behavioral conjoint therapy for patients with PTSD. The study measured “PTSD symptoms, as wells as symptoms of depression, sleep quality and relationship satisfaction,” following a one-month course of innovative treatment method. During 2 of the sessions that took place as part of the course of treatment, patients were given the option of receiving either 100 mg or 75 mg of MDMA. All subjects were made aware of the doses of MDMA used in the study.
According to MAPS, the results of their most recent Phase 2 trial indicated that “53% of 74 participants no longer qualified for PTSD … compared to 23% who received placebo or comparator dose,” also citing that 66% of patients interviewed subsequently no longer had PTSD.
Given the wide-scale legalization of medical marijuana, and the recent developments regarding MDMA, should clinicians expect “street” drugs to become commonplace in patient treatment? MAPS takes care to debunk this notion by differentiating MDMA from street drugs such as “ecstasy” or “molly.” According to their website, “Substances sold on the street under these names may contain MDMA, but frequently also contain unknown and/or dangerous adulterants.”
Similar logic was used when Michigan passed pharmaceutical-grade marijuana legislation in the 2013-2014 legislative session, which specified standards for safety and purity of marijuana as a legal treatment in the event that the substance is removed from the Schedule I classification by the Drug Enforcement Administration (DEA). Although the DEA fell short of rescheduling marijuana earlier this year, the administration did take steps toward increased testing for its medicinal applications.
As research continues related to the use of currently illegal substances for medicinal use, pharmacists need to stay current with the latest research to make sure that we can continue to take care of our patients to the greatest degree possible.