On Sept. 13, information about the results of a new Phase 3 Trial of MDMA-assisted therapy for PTSD treatment was published by the Multidisciplinary Association for Psychedelic Substances (MAPS). The organization announced that the results of its MAPP2 study have been peer reviewed by the experts with the journal Nature Medicine.
The study analyzed the reaction of 104 participants who suffer from PTSD. Each individual was randomly provided with MDMA or a placebo pill over the course of three sessions, one per month, for three months.
The most common listed side effects among those who received MDMA included muscle tightness, nausea, decreased appetite, and sweating. Following the conclusion of participant involvement, researchers found that 86% of the MDMA group improved on their standard PTSD assessment, compared to 69% of the placebo group. A standard PTSD assessment measures the severity of PTSD symptoms, including anxiety, phobias, insomnia, emotional numbness, and more.
When the study concluded, researchers found that 72% of people within the MDMA treatment group didn’t match the criteria for PTSD, vs. only 48% of the placebo participants.
Georgia-based Emory Healthcare Veterans Program executive director Barbara Rothbaum called the results “very exciting.” There is other evidence that PTSD can be treated with certain medications, or even talk therapy, but Rothbaum said that more research is needed to develop a new alternative for PTSD patients. “They are very effective, but nothing is 100% effective,” Rothbaum said. “So we absolutely need more options for treatment.”
According to Amy Emerson, CEO of the MAPS Public Benefit Corporation, the nonprofit intends to seek U.S. approval to sell MDMA (aka ecstasy or molly) as a treatment for PTSD. “It’s the first innovation in PTSD treatment in more than two decades. And it’s significant because I think it will also open up other innovation,” Emerson told AP News.
MAPS founder and president Rick Doblin, a longtime advocate of psychedelics as medicine, released a statement regarding the newest study. “Thanks to the combined efforts of dozens of therapists, hundreds of participants who volunteered in MAPS-sponsored trials, and many thousands of generous donors, MDMA-assisted therapy for PTSD is on track to be considered for approval by the FDA in 2024. Nature Medicine has published the results of the second MAPS-sponsored Phase 3 trial of MDMA-assisted therapy for PTSD, confirming our prior results,” Doblin stated in a press release. “We hope that MDMA-assisted therapy for PTSD will be approved by the FDA next year—and that our Open Science, Open Books principle will inspire researchers to make this just the first of many psychedelic-assisted therapies to be validated through diligent research.”
Although these studies help illuminate the benefits of MDMA as a medical treatment, there are a lot of hoops and hurdles that must be dealt with first. The Food and Drug Administration (FDA) needs to approve the substance as a treatment first, and the Drug Enforcement Administration would also need to reschedule cannabis’s current classification as a Schedule I substance.
Currently, MDMA is a Schedule I substance, among others including cannabis, LSD, heroin, methaqualone, and peyote. However, with the recent news that the Department of Health and Humans Services (HHS) recommends that cannabis be reclassified, and the DEA now reviewing the recommendation, it’s possible that other substances like MDMA could also receive similar treatment in the future.
Many news articles last week claimed that the DEA is “likely” to recommend rescheduling cannabis under the Controlled Substances Act. Many legislators not in agreement have written letters calling the move “irresponsible,” and some recently introduced legislation to block any progress for legalization without congressional approval.
In July, Australia became the first country in the world to allow doctors to prescribe psilocybin and MDMA. It took the Australian Therapeutic Goods Administration three years of discussion and extensive consultation with experts. MDMA was approved as a treatment for PTSD, and psilocybin was approved for treatment-resistant depression.
Multiple studies have been published regarding the efficacy of MDMA as a medical treatment. From researchers at University of New Mexico, a study is examining how MDMA can be used for new mothers experiencing opioid use disorder. A study published in the journal Scientific Reports found that MDMA is useful in treating mental health-related conditions when also used with either psilocybin or LSD. In June, one former white supremacist claims in his book that MDMA helped dispel bigotry.
Similarly, many studies have found that psilocybin can help patients with treatment-resistant depression. “These findings add to increasing evidence that psilocybin—when administered with psychological support—may hold promise as a novel intervention for MDD [major depressive disorder],” researchers explained.
In Oregon, more than 3,000 people are waitlisted to attend a legal psilocybin service center—some of which come from various parts of the world. According to the Oregon Psilocybin Services section manager Angela Allbee many patients have shared their experiences in using psilocybin. “So far, what we’re hearing is that clients have had positive experiences,” Allbee said.