MDMA Found Effective for Treatment of PTSD in Phase-3 Trial Results

3,4-methylenedioxymethamphetamine (MDMA), also known as “molly,” has been found to be highly effective for the treatment of post-traumatic stress disorder (PTSD) when used with conventional therapy and psychotherapy methods. The phase 3 clinical trial results were presented Tuesday at the American Chemical Society meeting in San Diego, California.

A review of data from the phase 3 results showed that MDMA was highly effective at treating PTSD when combined with psychotherapy. This efficacy carried over to participants who had the much more severe treatment-resistant form of PTSD (TR-PTSD) and those with substance abuse disorders.

The trials were conducted with 90 participants, all diagnosed with PTSD and some with TR-PTSD. The participants who received MDMA saw a reduction in their Clinician-Administered PTSD Scale (CAPS-5) of at least 20 points and a significant reduction of reported symptoms. In contrast, the control group, which received a placebo, saw a 14 point improvement.

While a six-point difference may not seem like a significant reduction vs. placebo, this is more than enough to move a patient out of the above PTSD categories. Representing a very positive change in their quality of life.

CAPS-5 scales from 0 to 80 points and is the Veteran Administration’s go-to standard for measuring the severity of PTSD symptoms. The scale uses a 30 line item questionnaire to assess the severity of a patient’s condition. Furthermore, CAPS-5 also measures the frequency and intensity of symptoms. Making it an invaluable tool for assessing a patient’s mental health.

Based on CAPS-5 scoring, a 20 point reduction represents a significant improvement for an individual’s mental health. While it is typically associated with military veterans, affecting 11-20 out of every 100 individuals, it can impact anyone who has survived a traumatic experience.

What methods did the clinical trial use?

Clinicians and researchers conducting the trial had a pool of 90 individuals with a CAP-5 score of 35 or higher. These scores place every participant in the chronic, severe, or extreme categories of PTSD symptoms. Participants received three 90-minute preparatory psychotherapy sessions, followed by the administration of three 8-hour active MDMA or placebo sessions. Nine 90-minute integrative psychotherapy coaching sessions then followed this.

This contrasts with the previous phase 2 trials, which only administered MDMA throughout two sessions. Researchers attribute the phase 3 trials improved efficacy to this 3rd MDMA session.

What do these results mean?

PTSD affects 11.8 million Americans, with many of them suffering from debilitating symptoms that disrupt their lives. Veterans, in particular, are twice as likely to develop PTSD. PTSD can compound other underlying conditions, including suicidal ideation, which veterans are also significantly more likely to be experienced.

This study and a review of six phase 2 clinical trials conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS) showed an overall reduction of 54.2% for patients to meet the criteria for having severe PTSD during follow-up sessions.

That over 50% reduction in symptom severity greatly improves patients’ lives. If given FDA approval and implemented on a wide scale, researchers estimate it could save $103.2 million in treatment costs for 1000 patients over a 30-year scale (for patients that meet treatment criteria).

While saving costs and improving patient outcomes is always a positive. This study and others currently being run by MAPS represent something more. They show that MDMA and other psychedelics are safe and highly effective potential treatments for some of the worst treatment-resistant conditions. The number of lives that novel treatments like MDMA could save is unknown. Still, it is safe to say that these results represent real, positive change for how America treats entrenched mental health conditions.

David Connell is a U.S. Air Force Veteran writer and author of Cooking with Magic: The Psilocybin Cookbook. David holds a B.A. in Communications and Creative Writing from the University of Tennessee, Knoxville. Connect with him about drug policy reform, his thoughts on research in novel psychedelic therapies, creative writing, and his unabashed love for Science Fiction on Twitter, LinkedIn, and Instagram.

Sources:
Marseille, E., Mitchell, J. M., & Kahn, J. G. (n.d.). Updated cost-effectiveness of MDMA-assisted therapy for the treatment of posttraumatic stress disorder in the United States: Findings from a phase 3 trial. PLOS ONE. Retrieved March 24, 2022, from https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0263252
Va.gov: Veterans Affairs. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). (2018, September 24). Retrieved March 24, 2022, from https://www.ptsd.va.gov/professional/assessment/adult-int/caps.asp