MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study
Julane Andries, Lisa Jerome, Evan Sola, Scott Hamilton, Amy Emerson, Rick Doblin, Philip E. Wolfson, Allison A. Feduccia, Julie B. Wang, Emily D. Williams, Shannon Carlin, Berra Yazar-Klosinski, Michael C Mithoefer
Scientific Reports November 24, 2020 DOI: 10.1038/s41598-020-75706-1 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Double-blind Open-label Pilot study Peer reviewed |
|---|---|
| Sample size | 18 |
| Population | People with life-threatening illnesses and anxiety |
| Intervention | MDMA-assisted psychotherapy |
| Dose | 125 mg |
| Duration | Two 8-hour psychotherapy sessions, with follow-up at one month, six months, and twelve months after the last experimental session |
| Topics | Anxiety MDMA Psychedelic-assisted therapy |
| Keywords | Randomized controlled trial Distress Placebo Population Clinical psychology Clinical trial Psychotherapist |
| Citations | 170 |
| Registration | NCT02427568 |
| Key findings | MDMA-assisted psychotherapy led to a greater reduction in anxiety scores than placebo, but the group difference was not statistically significant. |
Abstract
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. Trial Registration : clinicaltrials.gov Identifier: NCT02427568, first registered April 28, 2015.
In the evidence
This study is part of the evidence base for 2 syntheses in the library. Here is how each one recorded it.
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MDMA-assisted psychotherapy produced a greater reduction in anxiety scores than placebo, but the group difference did not reach statistical significance.
Synthesized
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MDMA-assisted psychotherapy led to a greater reduction in anxiety scores than placebo, but the group difference did not reach statistical significance (p = .056).
Synthesized
Comparable studies
Other randomized controlled trials on MDMA for anxiety, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Gender differences in the subjective effects of MDMA Healthy volunteers with no or minimal MDMA experience | 2001 | Pooled analysis of three double-blind placebo-controlled studies | n = 74 |
| Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Autistic adults with marked to very severe social anxiety | 2018 | Randomized controlled trial | n = 12 |
| A randomized controlled trial of 3,4-methylenedioxymethamphetamine (MDMA) and fear extinction retention in healthy adults Healthy adults aged 21–55 from a major metropolitan area | 2022 | Randomized controlled trial | n = 34 |
| Effects of MDMA-assisted therapy for PTSD on self-experience Participants with severe PTSD | 2024 | Randomized controlled trial | n = 90 |
| Social anxiety and MDMA-assisted therapy investigation: a novel clinical trial protocol Adults with moderate-to-severe generalized social anxiety disorder | 2023 | Randomized open-label delayed treatment pilot study | n = 20 |