Medical research into using the psychedelic MDMA to treat post-traumatic stress disorder is being called into question following allegations that a clinical trial investigating the treatment was potentially tainted by misconduct.
The U.S. Food and Drug Administration is currently conducting a review of the psychedelic commonly called ecstasy for patients with PTSD. The treatment is being developed by the Multidisciplinary Association for Psychedelic Studies (MAPS) and its public benefit Lykos, which has conducted clinical trials in a bid to have the therapy approved by the FDA. In 2017, the FDA designated the MDMA-assisted treatment for PTSD as a breakthrough therapy, indicating it may be a significant improvement over existing therapies and clearing the way for further research.
The clinical trials tested MDMA in conjunction with intense therapy administered by a pair of therapists to a group of patients with PTSD. In one stage of the trial, 94 patients were given either MDMA or a placebo during three therapy sessions spaced one month apart. Participants also completed integration sessions to help them process their experiences during the drug therapy sessions.
At the end of the trial, 71% of participants in the MDMA group had experienced an improvement in symptoms and no longer met the diagnostic criteria for PTSD. Among the placebo group, 48% of participants had similar results. Some participants in both groups experienced adverse effects such as anxiety or heart palpitations, although none of the adverse effects were characterized as serious.
“Consistent with PTSD, suicidal ideation was observed in both groups,” the authors reported in the journal Nature Medicine, “MDMA did not appear to increase this risk, and no suicidal behavior was observed.”
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Author: A.J. Herrington / High Times
