MDMA-assisted psychotherapy for PTSD set for FDA approval by 2021
The results of a Phase 2 clinical trial in MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder (PTSD) have just been published in the peer-reviewed journal The Lancet Psychiatry. These impressive results, part of a series of trials engaged by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), led to the FDA expediting the new treatment and last year granting it Breakthrough Therapy Designation.
In 1985, the drug MDMA, or 3,4-Methylenedioxymethamphetamine, was classified with a Schedule 1 restriction in the United States. Despite over a decade of informal use in clinical conditions by psychotherapists, the drug's heavy legal restrictions put a freeze on research into its medical uses.
Since that time, a broad collective of scientists and researchers has been working to legitimize the drug and re-establish its positive medical uses. This newly published study outlines in detail the results from one of six Phase 2 trials sponsored by MAPS, an organization founded by researcher Rick Doblin in 1986 to help foster study into the medical uses of psychedelic substances.
This small but important trial recruited 26 individuals with PTSD, including war veterans, firefighters and police officers. The extensive treatment process began with each subject undergoing three 90-minute psychotherapy sessions. Then the subjects were randomly assigned into three different MDMA dosage categories: 30 mg, 75 mg, or 120 mg.
The drug was administered as part of an eight-hour session that included close guidance by a trained psychotherapist. Over the following weeks, several non-drug assisted psychotherapy sessions were also incorporated with the goal of integrating and solidifying the primary experience. Only two MDMA-assisted sessions were conducted, spaced three to five weeks apart.
One of the fundamental hurdles faced with research into strongly psychoactive substances is that it is difficult to incorporate a blind control into the study. Participants receiving a placebo will quickly realize they have received an inactive drug, ultimately making it difficult to gather data with a traditional blind control group. To try to account for this, the researchers marked the 30 mg, low-dose group as an active placebo control. The low-dose is considered generally sub-threshold for strong psychoactive effects but still potentially resulting in a physically felt experience.
In this particular study the reported success rates were rather remarkable, with 68 percent of those subjects in the full-dose group no longer meeting the diagnostic criteria for PTSD one month after the second MDMA session. In contrast, only 29 percent of the low-dose (active placebo) group reported those same positive results.
"At least one in two PTSD patients cannot tolerate or do not respond adequately to existing treatments, so there is an urgent need for better treatments for the millions of military veterans and others with PTSD," says Ann Mithoefer, one of the lead researchers on the trial. "These results are further evidence that MDMA, used just two times at monthly intervals, can make psychotherapy much more effective and better tolerated. I'm excited that Phase 3 trials will soon confirm whether this therapy can be approved for widespread use in a few years."
These large-scale Phase 3 trials, set to commence over the coming months, are the final stages of a long process working to shift MDMA back into clinical and medicinal uses. MAPS estimates a final FDA approval to come by 2021 if these upcoming trials demonstrate similar efficacy and safety profiles.
The study was published in the journal The Lancet Psychiatry.