A groundbreaking human trial achieved highly statistically significant results and an excellent safety record, demonstrating that MDMA-assisted therapy can be an effective treatment for severe and chronic post-traumatic stress disorder (PTSD).
At the end of the randomized, blinded phase 3 trial, conducted by the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), 67% of participants who received three sessions of MDMA-assisted therapy no longer even qualified for a diagnosis of PTSD, and 88% experienced a clinically significant reduction in symptoms.
The pivotal study treated 90 patients with severe chronic PTSD from any cause with an average duration of 14 years, and replicated the successful results of its phase 2 trials.
Study participants included patients with PTSD caused by combat-related events; accidents; abuse; and sexual harm, and 84% have a history of developmental trauma.
“While many forms of PTSD therapy involve remembering past trauma, MDMA’s unique ability to increase compassion and understanding while squashing fear is probably what allows it to be so effective,” says Jennifer Mitchell, Ph.D., main author of the paper.
The peer-reviewed article was published in Nature medicine 10th May.
In the first phase 3 trial of any psychedelic-assisted therapy, participants who received MDMA plus manual therapy reported a significant reduction in PTSD symptoms compared to those who received placebo with therapy (p <0.0001).
67% of the MDMA group, compared to 32% of the placebo group, no longer qualified for a PTSD diagnosis after three treatment sessions. Additionally, participants treated with MDMA-assisted therapy had statistically significant reductions in symptoms such as depression, relative to placebo with therapy (p = 0.0116).
“People with the most difficult-to-treat diagnoses, often considered untreatable, respond as well to this new treatment as other study participants,” Mitchell said. “In fact, participants diagnosed with the dissociative subtype of PTSD experienced a greater reduction in symptoms than those without the dissociative subtype.”
Designed under a Special Protocol Evaluation with the FDA, the trial treated 90 patients with severe chronic PTSD. Participants were randomly assigned to receive three sessions of MDMA or placebo with identical talk therapy. 46 participants received MDMA therapy and 44 participants received placebo therapy. The primary efficacy endpoint was based on change from baseline in an independently assessed clinical interview of PTSD severity after 18 weeks.
The raters also measured the average change in functional decline in work / school, social and family life. Among participants in the MDMA-assisted therapy group, 88% experienced a clinically significant reduction in symptoms, compared to 60% in the placebo group.
In the phase 3 trial, the researchers saw no serious safety or tolerability problems in the MDMA group. MDMA did not increase the risk of suicidal thoughts or behaviors and did not increase cardiovascular risk or abuse potential relative to placebo therapy. As expected from previous clinical trials, temporary increases in blood pressure and pulse were observed during the MDMA sessions; Adverse events such as muscle tension, decreased appetite, nausea, sweating, and feeling cold lasted for only a short period of time.
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The PTSD researcher and author of the seminal book on PTSD, The Body Keeps the Score, served as the principal investigator for the Boston study site. He explains: “The experience of being traumatized profoundly alters perceptions; personal experience; and the ability to plan, imagine, and anticipate. For 88% of people who receive this treatment, we can expect to see a response to treatment. This can lead to fundamental changes in the perspective of our subjects on their own capacity, the regulation of affect and the attitude towards those around them. These results open the door to a potentially powerful new path to healing. “
A second phase 3 clinical trial is currently enrolling participants in 7 different US states In addition, MAPS plans to conduct other studies to explore the potential of this treatment for other mental health conditions, but always emphasize that this experimental therapy “needs the right environment to truly guide change and recovery “.
The FDA defines MDMA, also known as ‘ecstasy’, included in Schedule I, as a drug that has no “medical benefits” and is therefore not currently accessible as a treatment for any condition, except when administered in clinical trials. Thanks to MAPS, founded 35 years ago, and its scientific rigor, this is likely to change soon. Its goal is an FDA approval in 2023 as a ‘therapy designated as a breakthrough’.
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