MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study
Andries, J., Carlin, S. C., Doblin, R., Emerson, A., Feduccia, A. A., Hamilton, S., Jerome, L., Mithoefer, M. C., Sola, E., Wang, J. B., Williams, E., Wolfson, P. E., Yazar-Klosinski, B.
This double-blind, placebo-controlled study (n=18) with MDMA (125mg, 2-3 sessions) in combination with psychotherapy found no significant difference in anxiety in a population with life-threatening illnesses. Though no significant group difference was found (p=.056), the study showed a large effect size (g=1.03) and a larger sample size might find a significant difference (favouring MDMA).
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.