A newly published study of MDMA-assisted psychotherapy for people diagnosed with posttraumatic stress disorder illustrates the striking results that led federal regulators to expedite the process for approving the drug, which has been banned since 1985, as a prescription medicine. One year after the last of three MDMA sessions, three-quarters of the 25 subjects who completed the study, reported today in the Journal of Psychopharmacology, no longer qualified for a PTSD diagnosis.
The subjects were randomly assigned to receive 40, 100, or 125 milligrams of MDMA, with the lowest dose serving as a placebo. At the beginning of the study, which was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and conducted in Boulder, Colorado, under the supervision of licensed professional counselor Marcela Ot'alora, the mean scores of the three subject groups on the Clinician-Administered PTSD Scale (CAPS) were 84.8, 94.4, and 93.5, respectively. After the first two sessions, those scores fell by an average of 11.5, 24.4, and 26.3 points, or by 14 percent, 26 percent, and 28 percent.
The subjects who received the low dose in the first two sessions were later given an opportunity to take active doses, after which their mean CAPS score fell by another 47 percent. All three groups of subjects showed continued improvement at the one-year followup, when the average CAPS score was 31, down from 92 at baseline. That's a drop of 66 percent. The highest possible CAPS score is 136, and the cutoff for a PTSD diagnosis is 50. By the end of the study, 19 of the 25 subjects (76 percent) were below that threshold.
Previous research sponsored by MAPS found similarly dramatic improvements. In a study overseen by Charleston, South Carolina, psychiatrist Michael Mithoefer that was reported last May in The Lancet Psychiatry, mean CAPS scores fell by 58 points in the medium-dose group and 43 points in the high-dose group, compared to 11 points in the low-dose group. After the first two sessions, 68 percent of the medium- and high-dose subjects no longer met the diagnostic criteria for PTSD, compared to 29 percent of the low-dose subjects. (Those differences, unlike the ones noted by Ot'alora and her colleagues, were statistically significant.) At the one-year follow-up, after all three groups had received active doses, the mean CAPS score had fallen by 55 percent, from 87.1 to 38.8.
"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," Ot'alora said in a MAPS press release. "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 Mithoefer and Ot'alora studies were both Phase 2 clinical trials. Phase 3 trials, which began last month, will involve 200 to 300 subjects at 16 sites in the United States, Canada, and Israel. If those trials are successful, MAPS says, the FDA, which last year deemed MDMA a "breakthrough therapy," could approve it as a medicine as soon as 2021.