MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study.
Study Goal
The researchers aimed to investigate the effectiveness and safety of MDMA-assisted psychotherapy for treating anxiety in individuals with life-threatening illnesses (LTI).
Results Summary
The MDMA group showed a greater reduction in anxiety scores compared to placebo, though the difference did not reach statistical significance (p = .056). MDMA was well-tolerated, with no major safety concerns reported.
Population
Individuals with anxiety related to life-threatening illnesses (LTI).
Effective Dosage
125 mg MDMA per session, administered during two 8-hour psychotherapy sessions initially, with additional open-label sessions post-unblinding.
Duration
Primary outcome measured one month post-intervention, with follow-ups at six and twelve months after the last experimental session.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
MDMA-assisted psychotherapy | decrease | State-Trait Anxiety Inventory (STAI) Trait scores | Participants with anxiety from a life-threatening illness (LTI) | -23.5 (13.2) | had a greater mean reduction | #1 |
placebo in combination with two 8-h psychotherapy sessions | decrease | State-Trait Anxiety Inventory (STAI) Trait scores | Participants with anxiety from a life-threatening illness (LTI) | -8.8 (14.7) | reduction | #2 |
MDMA-assisted psychotherapy | no change | State-Trait Anxiety Inventory (STAI) Trait scores | Participants with anxiety from a life-threatening illness (LTI) | p = .056 | results did not reach a significant group difference | #3 |
MDMA-assisted psychotherapy | neutral | - | Participants with anxiety from a life-threatening illness (LTI) | 1.03 (95% CI: -5.25, 7.31) | Hedges' g between-group effect size | #4 |
MDMA | neutral | - | this sample | - | was well-tolerated | #5 |
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.Trial Registration: clinicaltrials.gov Identifier: NCT02427568, first registered April 28, 2015.