An international study involving researchers from University of British Columbia Okanagan Campus has shown that MDMA, also known as ecstasy, may be a valuable tool for treating post-traumatic stress disorder (PTSD). The study demonstrated substantial improvements in individuals who had not responded to prior treatments, explains UBCO associate professor of psychology Zach Walsh. This is also, he adds, the most comprehensive evaluation of the safety and effectiveness of MDMA-assisted psychotherapy for PTSD.
“PTSD symptoms decreased after one session of MDMA together with psychotherapy,” says Walsh, study co-author. He adds that 54% of participants no longer met PTSD criteria after two sessions and that there was also improvement in their symptoms of depression.
The response of participants to MDMA-assisted psychotherapy was compared to those who received small doses or non-drug psychotherapy.
“These findings are promising and indicate the needed for larger studies,” says Walsh. “Too many people with PTSD struggle to find effective treatment, and use of MDMA in a supportive environment with trained mental health professionals could be an important addition to our treatment options.”
Ecstasy, also known as Molly, is the nickname for MDMA – a synthetic drug made from a combination of methylenedioxy-methamphetamine. It is a controlled, illegal drug in Canada classified as a stimulant with hallucinogenic properties.
Walsh, as well as researchers from the US, Switzerland and Israel, examined the results from six clinical trials, involving 103 people. Trial participants included men and women with chronic, treatment-resistant PTSD from a wide variety of causes.
Based on these results, the US Food and Drug Administration granted breakthrough therapy designation to MDMA-assisted psychotherapy for PTSD, acknowledging that it “may demonstrate substantial improvement over existing therapies” and agreeing to expedite its development and review.
The first of two more in-depth clinical trials of MDMA-assisted psychotherapy for PTSD began enrolling participants in November 2018, and aims to have 100-150 volunteers across 15 sites in the US, Canada and Israel. The second trial will take place after an interim analysis of the data from the first trial, and will enrol an additional 100-150 participants. European trials are planned to start in the near future.
Nearly 4% of all people worldwide will suffer from PTSD during their lifetime. PTSD can be a debilitating disorder, with symptoms including intrusive thoughts and memories, negative effects on thinking and mood, depression, hyperarousal and reactivity, and avoidance. People with PTSD can experience much lower quality of life and relationships, related mental health conditions and suicidal tendencies.
Background: Posttraumatic stress disorder is a prevalent mental health condition with substantial impact on daily functioning that lacks sufficient treatment options. Here we evaluate six phase 2 trials in a pooled analysis to determine the study design for phase 3 trials of MDMA-assisted psychotherapy for PTSD.
Methods: Six randomized, double-blind, controlled clinical trials at five study sites were conducted from April 2004 to February 2017. Active doses of MDMA (75–125 mg, n = 72) or placebo/control doses (0–40 mg, n = 31) were administered to individuals with PTSD during manualized psychotherapy sessions in two or three 8-h sessions spaced a month apart. Three non-drug 90-min therapy sessions preceded the first MDMA exposure, and three to four followed each experimental session.
Results: After two blinded experimental sessions, the active group had significantly greater reductions in CAPS-IV total scores from baseline than the control group [MMRM estimated mean difference (SE) between groups − 22.0 (5.17), P < 0.001]. The between-group Cohen’s d effect size was 0.8, indicating a large treatment effect. After two experimental sessions, more participants in the active group (54.2%) did not meet CAPS-IV PTSD diagnostic criteria than the control group (22.6%). Depression symptom improvement on the BDI-II was greatest for the active group compared to the control group, although only trended towards significant group differences [MMRM, estimated mean difference (SE) between groups − 6.0 (3.03), P = 0.053]. All doses of MDMA were well tolerated, with some expected reactions occurring at greater frequency for the active MDMA group during experimental sessions and the 7 days following.
Conclusions: MDMA-assisted psychotherapy was efficacious and well tolerated in a large sample of adults with PTSD. These studies supported expansion into phase 3 trials and led to FDA granting Breakthrough Therapy designation for this promising treatment.
Michael C Mithoefer, Allison A Feduccia, Lisa Jerome, Anne Mithoefer, Mark Wagner, Zach Walsh, Scott Hamilton, Berra Yazar-Klosinski, Amy Emerson, Rick Doblin