Trial PaperPTSDAnxiety DisordersSet & SettingEquity and EthicsMDMA

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.

Authors

  • Rick Doblin
  • Magí Farré
  • José Carlos Bouso

Published

Journal of Psychoactive Drugs
individual Study

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.

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

Introduction

3,4-Methylenedioxymethamphetamine (MDMA) is described as an entactogen with a pharmacological profile that preferentially affects the emotional sphere, and it has a history of psychotherapeutic use prior to its prohibition in the 1980s. Earlier, largely uncontrolled clinical and anecdotal reports suggested MDMA could facilitate access to traumatic memories by reducing fear and anxiety, thereby strengthening the therapeutic alliance and potentially improving outcomes in disorders such as posttraumatic stress disorder (PTSD). However, formal, government‑approved controlled data in clinical populations were scarce at the time this study was initiated. This study set out to investigate the safety of single, ascending doses of MDMA administered as an adjunct to psychotherapy in women with chronic, treatment‑resistant PTSD secondary to sexual assault, and to obtain preliminary efficacy data. The trial was approved by the Ethics Committee of University Hospital La Paz and the Spanish Ministry of Health. Although the original protocol planned to enrol 29 participants across five dose levels, political decisions led to an early termination after only six subjects had been treated; the paper therefore reports preliminary findings from that small sample.

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References (2)

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