Trial PaperAnxiety DisordersDepressive DisordersPalliative & End-of-Life DistressMDMA

MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study

This randomised, double-blind pilot study found that MDMA-assisted psychotherapy produced a larger mean reduction in trait anxiety at one month in people with life‑threatening illness (−23.5 vs −8.8) but the group difference did not reach statistical significance (p = .056) and effect estimates were imprecise. MDMA was well tolerated, and the findings support conducting larger trials to evaluate this treatment approach.

Authors

  • Rick Doblin
  • Berra Yazar-Klosinski
  • Michael Mithoefer

Published

Scientific Reports
individual Study

Abstract

The success of modern medicine creates a growing population of those suffering from life-threatening illnesses (LTI) who often experience anxiety, depression, and existential distress. We present a novel approach; investigating MDMA-assisted psychotherapy for the treatment of anxiety in people with an LTI. Participants with anxiety from an LTI were randomized in a double-blind study to receive MDMA (125 mg, n = 13) or placebo (n = 5) in combination with two 8-h psychotherapy sessions. The primary outcome was change in State-Trait Anxiety Inventory (STAI) Trait scores from baseline to one month post the second experimental session. After unblinding, participants in the MDMA group had one open-label MDMA session and placebo participants crossed over to receive three open-label MDMA sessions. Additional follow-up assessments occurred six and twelve months after a participant’s last experimental session. At the primary endpoint, the MDMA group had a greater mean (SD) reduction in STAI-Trait scores, − 23.5 (13.2), indicating less anxiety, compared to placebo group, − 8.8 (14.7); results did not reach a significant group difference (p = .056). Hedges’ g between-group effect size was 1.03 (95% CI: − 5.25, 7.31). Overall, MDMA was well-tolerated in this sample. These preliminary findings can inform development of larger clinical trials to further examine MDMA-assisted psychotherapy as a novel approach to treat individuals with LTI-related anxiety.

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Study Details

References (26)

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