MDMA and post-traumatic stress disorder

It is a psychotherapy programme in which some sessions take place under the effect of MDMA, with preparation beforehand and integration sessions afterwards.¹ In the trials, MDMA was always given within this programme, never on its own, and the comparison was with the same psychotherapy plus placebo.^1,2

Post-traumatic stress disorder has a page of its own, covering symptoms, assessment and usual treatments: Post-traumatic stress disorder.

They showed a greater reduction in symptoms with MDMA than with placebo, in both cases with the same psychotherapy. The first trial, published in 2021, included people with severe PTSD;¹ the second, published in 2023, people with moderate to severe PTSD.²

In 2024, a scientific journal retracted three papers based on pooled analyses of the phase 2 trials, because of protocol violations amounting to unethical conduct at one site. The phase 3 trial papers were not retracted.⁶

It judged the evidence insufficient for approval. In June 2024, an FDA advisory committee voted by a majority against demonstrated efficacy and against a favourable benefit–risk balance.⁴ The FDA stressed that MDMA’s effects make it almost impossible to blind treatment, which can introduce expectation bias, and noted that adverse effects linked to abuse potential had not been collected systematically.³

In August 2024, the FDA did not approve the application and asked for an additional phase 3 trial.⁵ The same year, an independent US report found the public evidence insufficient to judge benefits and harms, pointing to functional unblinding and concerns about how the trials were designed and conducted.⁷

On 9 August 2026, the specialist publication Psychedelic Alpha reported that the company developing MDMA, now Resilient Pharmaceuticals (formerly Lykos Therapeutics), had filed its application with the FDA again without running another phase 3 trial.⁸ The next day, 10 August, MAPS, which founded the company, reacted to the report.⁹ The report relied on unnamed sources: the company has not confirmed it publicly and, so far, the FDA has not announced a decision.^8,9

In July 2026, the FDA published final guidance on how to conduct clinical trials with psychedelics, including the question of blinding.¹⁰

Trauma-focused psychotherapies, such as cognitive processing therapy, prolonged exposure and eye movement desensitisation and reprocessing (EMDR), are the first-line treatment recommended by international guidelines.^11,12 Medication has its own place, decided case by case.¹¹

The most relevant risks are cardiovascular. In controlled studies in healthy volunteers, MDMA raised blood pressure, heart rate and body temperature in a relevant proportion of people, and the risk is likely to be higher in people with heart disease.¹³ Other known risks:

• hyponatraemia, a dangerous fall in blood sodium, especially with excessive water intake;¹⁴
• a rise in body temperature;¹³
• abuse potential, which the FDA considered similar to that of other controlled stimulants.³

For this reason, in the trials, the prior assessment covered cardiovascular health, current medication and psychiatric history, with monitoring during sessions.^1,3

In the European Union, MDMA is not an authorised medicine; in Portugal, its clinical use is limited to clinical trials.¹⁶ Australia has allowed specifically authorised psychiatrists to prescribe MDMA for post-traumatic stress disorder since July 2023, even though no registered medicine exists.¹⁵ In the United States it is not approved.^5,8

• How much of the effect holds up in a design that better controls expectation.^3,7
• How long the benefits last and whether booster sessions are needed.⁷
• What training and supervision therapists should have.⁷
• Safety outside the controlled conditions of trials, including abuse potential.³

• Have I completed a full course of trauma-focused psychotherapy with a specifically trained therapist?
• Are there other conditions, such as depression, substance use or sleep problems, that should be treated at the same time?
• Would my cardiovascular health allow me to take part in a clinical trial?
• Are there clinical trials under way for which I might be eligible?