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Methylenedioxymethamphetamine (MDMA)-Assisted Therapy in Hawaii: A Brief Review

Ann M. Inouye, Aaron Wolfgang · 2022 · 5 citationsRead the paper

The Food and Drug Administration (FDA) granted breakthrough therapy status to 3,4-methyl​enedioxy​methamphetamine-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. Methyl​enedioxy​methamphetamine is also a Schedule I controlled substance and has proven to be a treatment option that could potentially benefit the people of Hawaii.

What the full text shows

Working prototype
  • MDMA-AT participants no longer met PTSD diagnosis criteria after two sessions. — 54% vs. 23% in control group (Treatment-resistant PTSD, phase-II clinical trials)
  • MDMA-AT participants no longer met PTSD diagnosis criteria after three sessions. — 67% (First phase-III clinical trial)
  • Long-term durability of PTSD remission after MDMA-AT. — 67% at one year; 74% at nearly four years (Treatment-resistant PTSD)
  • Reduction in reported suicidal ideation. — 60% decreased to 24% (Treatment-resistant PTSD)
  • MDMA-AT is safe and well-tolerated with only transient, mild to moderate side effects. (Phase-III trials, including participants with comorbidities)
Setup
Phase-III trial included 90 participants with severe PTSD; Phase-II involved a series of six trials with treatment-resistant PTSD patients.
How
Review of clinical trial data (Phase-II and Phase-III) involving MDMA administration (80-120mg) combined with preparatory and integrative psychotherapy sessions. The paper also discusses the neurobiological mechanism of oxytocin release and a mouse model study on social reward learning.
Limitations
MDMA is currently a Schedule I controlled substance. · Phase-III trials were still nearing completion/publication at the time of writing. · Translational pharmaceutical research for oxytocin is difficult as it does not cross the blood-brain barrier.

Summarized by Gemma 4 from the open-access full text · 8 Oct 2026. Read it