Evidence by condition / Post-traumatic stress disorder (PTSD)
MDMA-assisted therapy for PTSD: the evidence and the FDA decision
What the phase 3 trials of MDMA-assisted therapy for PTSD found, why the FDA did not approve it in 2024, and the lawful ways to take part today: clinical trials and, outside the US, authorised prescribers.
Strength of evidencePhase 3 trials, not approved
At least one completed phase 3 randomised trial, but no approval for this use in the United States. How we grade
- Two phase 3 randomised trials found larger reductions in PTSD symptoms with MDMA plus therapy than with placebo plus the same therapy. (Nature Medicine, 2021; Nature Medicine, 2023)
- The FDA did not approve it; the sponsor reported that the agency asked for another phase 3 trial. (Lykos Therapeutics (press release), 9 Aug 2024; eCFR (Office of the Federal Register), current)
Not medical advice. This page reports what published research, regulators and drug labels say, checked 26 Oct 2026. Talk to a doctor about your own situation; nothing here is a reason to start, stop or change a treatment on your own.
What the research shows
Clinical trialNature Medicine, 2021
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study
In 90 adults with severe PTSD, MDMA-assisted therapy reduced clinician-rated symptoms more than placebo with the same therapy.
Clinical trialNature Medicine, 2023
MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial
In 104 adults with moderate to severe PTSD, symptom scores fell 23.7 points with MDMA and 14.8 with placebo, both with identical therapy; no deaths or serious adverse events.
Clinical trialJournal of Psychopharmacology, 2011
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
The first randomised pilot, in 20 people with treatment-resistant chronic PTSD: 10 of 12 responded with MDMA against 2 of 8 with placebo.
Each study links to its own page with the design, size, results and limits, checked against PubMed.
Risks to know
Fatal serotonin toxicity has been reported.
Australian forensic researchers reported four deaths from serotonin toxicity caused by MDMA combined with moclobemide, a reversible MAO-A inhibitor; two involved moclobemide at common prescribed concentrations. A review of 106 Victorian coroner cases with MDMA (2002 to 2008) classed 4 MDMA plus moclobemide cases as high-risk interactions. (Forensic Science International, Pilgrim JL, Gerostamoulos D, Woodford N, Drummer OH, 2012; Journal of Analytical Toxicology, Pilgrim JL, Gerostamoulos D, Drummer OH, 2011)
SSRIs markedly blunt MDMA's effects.
In a placebo-controlled study of 16 healthy volunteers, pretreatment with the SSRI citalopram markedly reduced most of MDMA's psychological effects. A 2022 systematic review of 40 publications compiles the human evidence on psychiatric medications taken with MDMA or psilocybin. (Neuropsychopharmacology, Liechti ME, Baumann C, Gamma A, Vollenweider FX, 2000; Psychopharmacology (Berl), Sarparast A, Thomas K, Malcolm B, Stauffer CS, 2022)
Stronger effects on heart rate and blood pressure.
In a placebo-controlled crossover study in healthy subjects, the haemodynamic and adverse effects of methylphenidate and MDMA taken together were significantly higher than with either alone, without stronger psychoactive effects. On its own, MDMA raised systolic blood pressure above 160 mmHg in 33% of 166 healthy study subjects. (International Journal of Neuropsychopharmacology, Hysek CM, Simmler LD, Schillinger N, et al., 2014; Journal of Psychopharmacology, Vizeli P, Liechti ME, 2017)
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Lawful ways to get it
FDA statusNot lawfully available
- MDMA (3,4-methylenedioxymethamphetamine) is a Schedule I controlled substance under federal law. (eCFR (Office of the Federal Register), current)
- On 4 June 2024 the FDA's Psychopharmacologic Drugs Advisory Committee reviewed Lykos Therapeutics' application for midomafetamine (MDMA) with therapy for PTSD. It voted 9 to 2 that the data did not show the drug was effective, and 10 to 1 that its benefits with the FDA's proposed risk programme did not outweigh its risks. (U.S. Food and Drug Administration, 26 Jul 2024)
- Lykos Therapeutics announced on 9 August 2024 that the FDA had issued a complete response letter for midomafetamine for PTSD, saying it could not be approved on the data submitted to date, and that the FDA had asked for an additional phase 3 trial. No MDMA product is FDA approved. (Lykos Therapeutics (press release), 9 Aug 2024; eCFR (Office of the Federal Register), current)
Clinical trialsClinical trials
- The US Department of Veterans Affairs announced on 3 December 2024 that it would fund a study of MDMA-assisted therapy for veterans with both PTSD and alcohol use disorder, at the Providence (Rhode Island) and West Haven (Connecticut) VA medical centres, with a grant of about $1.5 million over five years. VA called it the first VA-funded study of psychedelic-assisted therapy since the 1960s, and said it strongly discourages self-medicating with psychedelics. (U.S. Department of Veterans Affairs, 3 Dec 2024)
- A listing on ClinicalTrials.gov means the sponsor registered the study, not that the US government evaluated it. (U.S. National Library of Medicine (NIH), Oct 2023)
What it costs
- Ask any trial team whether taking part costs anything, which expenses such as travel or lodging are reimbursed, and whether your insurance covers what the research does not. (National Institute on Aging (NIH), current page)
Recruiting trials for post-traumatic stress disorder (ptsd)
29 trials were recruiting on ClinicalTrials.gov on 26 Oct 2026, 21 with US sites, testing any psychedelic or ketamine; 12 of them test MDMA. The first 3 are below; the full list, by state, is on its own page.
Phase 2MDMANCT05790239
MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
- Conditions:
- Post Traumatic Stress Disorder
- Sponsor:
- Stephen Robert Marder
- Who:
- ages 18 Years and over, 40 participants planned
- VA Greater Los Angeles Healthcare System, Westwood campus, Los Angeles, California (not yet recruiting)
- West Los Angeles Veteran Affairs, Los Angeles, California
Phase 2/3MDMANCT07118839
MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder (MAP VETS)
- Conditions:
- Post Traumatic Stress Disorder; Alcohol Use Disorder
- Sponsor:
- VA Office of Research and Development
- Who:
- ages 18 Years and over, 80 participants planned
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut
- Providence VA Medical Center, Providence, RI, Providence, Rhode Island
Phase 2MDMANCT05219175
MDMA for Co-occurring PTSD and OUD After Childbirth
- Conditions:
- Stress Disorders, Post-Traumatic; Opioid Use Disorder
- Sponsor:
- University of New Mexico
- Who:
- ages 18 Years and over, 15 participants planned
- University of New Mexico Health Sciences, Albuquerque, New Mexico