MDMA-assisted psychotherapy using low doses in a small sample of women with chronic posttraumatic stress disorder

This small double-blind placebo-controlled study (n=6) studied the safety (psychological & physiological) of a low dose of MDMA (50-75mg) in women with chronic PTSD and found no adverse effects.

Abstract

“The purpose of this study was to investigate the safety of different doses of MDMA-assisted psychotherapy administered in a psychotherapeutic setting to women with chronic PTSD secondary to a sexual assault, and also to obtain preliminary data regarding efficacy. Although this study was originally planned to include 29 subjects, political pressures led to the closing of the study before it could be finished, at which time only six subjects had been treated. Preliminary results from those six subjects are presented here. We found that low doses of MDMA (between 50 and 75 mg) were both psychologically and physiologically safe for all the subjects. Future studies in larger samples and using larger doses are needed in order to further clarify the safety and efficacy of MDMA in the clinical setting in subjects with PTSD.”

Authors: José C. Bouso, Rick Doblin, Magí Farré, Miguel A. Alcázar & Gregorio Gómez-Jarabo

Notes

Many studies (and now Phase 3 clinical trials) followed this initial study. Notable are the first two by Mithoefer et al. (2010) and Oehen et al. (2012).

This study was supported by MAPS.

“As the objective of this study was to assess the safety of MDMA in a chronic PTSD population, a wide range of psychopathological scales was used in order to measure not only PTSD symptoms, but also its associated comorbidities, such as anxiety, depression, phobias, maladjustment and damaged self-esteem. Neither of the two doses of MDMA increased symptomatology in any of the psychopathological scales in any of the subjects treated, thus demonstrating that the doses administered in this trial were psychologically safe for all the subjects. Blood pressure, heart rate and other somatic side effects were also assessed and showed no significant elevation, again suggesting that the doses administered were physiologically safe.”

Following years of research only into the dangers of MDMA, this was a good sign and confirmation (from millions of ‘ecstasy’ dosages sold on the street without many adverse events) that MDMA is safe to use in a therapeutic/clinical setting.

See Ecstasy by Julie Holland for more research about the safety or Drugs: Without The Hot Air by David Nutt for a broader perspective.

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