Sleep Quality Improvements After MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder.
Linnae Ponté, Lisa Jerome, Scott Hamilton, Michael C Mithoefer, Berra Yazar-Klosinski, Eric Vermetten, Allison A. Feduccia
Journal of Traumatic Stress August 1, 2021 Expression of concern DOI: 10.1002/jts.22696 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled double-blind study Peer reviewed |
|---|---|
| Sample size | 63 |
| Population | Individuals with PTSD |
| Intervention | MDMA-assisted psychotherapy |
| Dose | 75-125 mg (active), 0-40 mg (placebo/control) |
| Duration | 2-3 sessions; primary endpoint at 1-2 months after blinded sessions; treatment exit and 12-month follow-up |
| Topics | Psychedelic-assisted therapy MDMA PTSD |
| Keywords | PTSD Treatment Trauma treatment Mental health recovery Profound recovery MDMA-Assisted Psychotherapy MDMA Therapy Ecstasy therapy Psychotherapeutic MDMA Sleep quality Restful sleep Sleep improvement Sleep enhancement Better sleep Sleep recovery Clinical research Investigation Medical study Scientific study Therapeutic research |
| Citations | 42 |
| Key points | MDMA-assisted psychotherapy improved self-reported sleep quality and reduced PTSD symptoms compared to placebo/control, with further sleep gains at 12-month follow-up. |
Abstract
Sleep disturbances (SDs) are among the most distressing and commonly reported symptoms in posttraumatic stress disorder (PTSD). Despite increased attention on sleep in clinical PTSD research, SDs remain difficult to treat. In Phase 2 trials, 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy has been shown to greatly improve PTSD symptoms. We hypothesized that MDMA-assisted psychotherapy would improve self-reported sleep quality (SQ) in individuals with PTSD and be associated with declining PTSD symptoms. Participants in four studies (n = 63) were randomized to receive 2-3 sessions of active MDMA (75-125 mg; n = 47) or placebo/control MDMA (0-40 mg, n = 16) during all-day psychotherapy sessions. The PSQI was used to assess change in SQ from baseline to the primary endpoint, 1-2 months after the blinded sessions. Additionally, PSQI scores were measured at treatment exit (TE) and 12-month follow-up. Symptoms of PTSD were measured using the CAPS-IV. At the primary endpoint, CAPS-IV total severity scores dropped more after active MDMA than after placebo/control (-34.0 vs. -12.4), p = .003. Participants in the active dose group showed more improvement in SQ compared to those in the control group (PSQI total score ΔM = -3.5 vs. 0.6), p = .003. Compared to baseline, SQ had improved at TE, p < .001, with further significant gains reported at 12-month follow-up (TE to 12-months ΔM = -1.0), p = .030. Data from these randomized controlled double-blind studies provide evidence for the beneficial effects of MDMA-assisted psychotherapy in treating SDs in individuals with PTSD.
Comparable studies
Other randomized controlled trials on MDMA and psychedelic-assisted therapy, most cited first.