A Colorado study has found lasting benefits from MDMA-assisted psychotherapy as a treatment for patients with chronic post-traumatic stress disorder. Results of the study, which was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), were published on Monday in the Journal of Psychopharmacology. The research is the largest clinical trial of MDMA-assisted psychotherapy for the treatment of chronic PTSD to be sanctioned by the U.S. Food and Drug Administration to date.
“Our findings support previous investigations of MDMA-assisted psychotherapy as an innovative, efficacious treatment for posttraumatic stress disorder,” the study concluded.
Principal investigator Marcela Ot’alora said in a press release that the study built on previous research, which showed promise for MDMA as a potential therapy for patients with PTSD.
“Our study demonstrated that different therapy teams were able to get similarly robust results, further strengthening the case for MDMA-assisted psychotherapy as a promising option for the treatment of PTSD,” said Ot’alora. “Plus, the results of the study indicate that this treatment has the potential to greatly improve the lives of people suffering from PTSD, regardless of the source of their trauma. After treatment, a great majority of our participants have reported feeling more connected to themselves and to others, more joy, more compassion, and with new skills for facing life’s challenges.”
The research included 28 participants with chronic PTSD from military service, sexual assault, and other causes. The double-blind, placebo-controlled, Phase 2 pilot study found that one month after their second day-long experimental session, nearly 43 percent in the active-dose (100 mg and 125 mg) MDMA groups did not qualify for a diagnosis of PTSD, compared to 33.3 percent in the low-dose MDMA (40 mg active placebo) control group. The results were even more significant 12 months after the third session, which found that one year following treatment with MDMA-assisted psychotherapy, 76 percent of participants no longer had PTSD.
Based on previous MAPS research, the FDA granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD last year, noting that it “may demonstrate substantial improvement over existing therapies.”
MDMA Research Continues
Brad Burge, the director of strategic communications for MAPS, told High Times via email that research into MDMA-assisted psychotherapy as a treatment for PTSD is continuing in three countries. Burge also invited PTSD patients interested in participating in the study to seek additional information online.
“Most of the 15 Phase 3 trial sites in the US, Canada, and Israel will start enrolling participants in November 2018, in just a few weeks,” Burge said. “Information about enrollment as well as an email sign-up for people interested in learning about enrolling in our clinical trials is available here: maps.org/participate/participate-in-research.”
Burge said that if the clinical trials continue to show success, MDMA could soon be approved as a treatment for PTSD by federal regulators.
“Assuming that the Phase 3 trial results are satisfactory to the FDA, the agency would approve the treatment as soon as 2021,” said Burge.
Once that happens, MDMA, which is currently a Schedule 1 drug under the Controlled Substances Act, would have to be reclassified to Schedule 2 or lower. Then, Borge said, MAPS plans to help make the treatment available to as many people with PTSD who need it as possible.
“We are working hard to ensure as wide accessibility to MDMA-assisted psychotherapy as possible once it’s approved, including getting it covered by private insurance and public health care plans,” said Burge.
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