Substance guideSubstances 1 min read
MDMA-assisted therapy: research and legal status
MDMA is being studied as an aid to therapy for PTSD. The FDA declined to approve it in 2024, and it remains illegal under US federal law outside approved research.
PsiloAtlas editorial · AI-assisted information, not clinical review · Reviewed 2026-10-12
What it is
MDMA (3,4-methylenedioxymethamphetamine) increases the release of serotonin and other brain chemicals, producing feelings of closeness and lowered fear. In therapy research it is given two or three times alongside many hours of talk therapy.
What the research shows
A 2021 Phase 3 trial in Nature Medicine (Mitchell et al.) found that 67% of participants with severe PTSD no longer met the diagnosis after MDMA-assisted therapy, compared with 32% who received therapy with a placebo.
Risks
MDMA raises heart rate, blood pressure and body temperature. It can interact dangerously with some antidepressants. Street 'ecstasy' or 'molly' is often mixed with other drugs.
Legal status
MDMA is in Schedule I of the federal Controlled Substances Act (21 CFR 1308.11).
In August 2024 the FDA issued a complete response letter declining to approve Lykos Therapeutics' application, requesting an additional Phase 3 study.
Utah's 2024 law (SB 266) lets qualifying health systems run psilocybin and MDMA treatment programs. Outside that and approved trials, no US state allows MDMA therapy.
Since July 1, 2023, Australia lets authorized psychiatrists prescribe MDMA for PTSD.