Methylenedioxymethamphetamine (MDMA)-Assisted Therapy in Hawaii: A Brief Review
Ann M. Inouye, Aaron Wolfgang
Cureus June 28, 2022 DOI: 10.7759/cureus.26402 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Series of phase-II clinical trials and a phase-III clinical trial Peer reviewed |
|---|---|
| Population | Participants with treatment-resistant PTSD |
| Duration | Two sessions (phase-II), three sessions (phase-III), with follow-up at one year and nearly four years |
| Topics | MDMA Psilocybin |
| Keywords | Methamphetamine Clinical trial Hallucinogen Pharmacology |
| Citations | 5 |
| Key findings | MDMA-assisted therapy led to 54% of full-dose participants no longer meeting PTSD diagnosis after two sessions in phase-II trials, and 67% after three sessions in the phase-III trial, with durable effects over years. |
Abstract
The Food and Drug Administration (FDA) granted breakthrough therapy status to 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) in 2017 due to preliminary evidence supporting its efficacy and safety in treating post-traumatic stress disorder (PTSD). A series of six phase-II clinical trials studying MDMA-AT for treatment-resistant PTSD found that 54% of MDMA-AT full-dose participants no longer met the diagnosis of PTSD after two MDMA sessions, compared to 23% in the control group. In the first phase-III clinical trial, 67% no longer met the criteria for PTSD after three sessions. The effects are durable, with 67% no longer diagnosable after one year and 74% at nearly four years. The MDMA-AT is being fast-tracked for potential FDA approval by 2023. In 2021, Hawaii's Senate Bill 738 unsuccessfully proposed that psilocybin be removed from the Schedule I controlled substances list due to its clinical efficacy for major depressive disorder. Methylenedioxymethamphetamine is also a Schedule I controlled substance and has proven to be a treatment option that could potentially benefit the people of Hawaii.
Comparable studies
Other non-randomized and open-label trials on MDMA, most cited first.
Citations in the library
Cited by 3
- Psychologists' and psychotherapists' knowledge, attitudes, and clinical practices regarding the therapeutic use of psychedelics Clinical Psychology & Psychotherapy July 2, 2023
- Psychedelic therapy in depression and substance use disorders European Journal of Neuroscience May 21, 2024
- Unlocking the potential of psychedelics as medicine: Past obstacles and future outlooks MIT Science Policy Review August 31, 2023
Cites 18
- MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine June 1, 2021
- The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. Journal of Psychopharmacology July 19, 2010
- Subjective Reports of the Effects of MDMA in a Clinical Setting Journal of Psychoactive Drugs October 1, 1986
- MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology September 1, 2019
- Oxytocin-dependent reopening of a social reward learning critical period with MDMA Nature April 3, 2019
and 13 more in the library