Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD) (PAM-VET)

This Phase I, double-blind, active-controlled trial (n=40) will investigate the safety and potential therapeutic effects of co-administered MDMA and psilocybin in military Veterans diagnosed with post-traumatic stress disorder (PTSD).

Conducted by Johns Hopkins University and supported by the Gracias Family Foundation, the study will enrol adults aged 21 and older who have had PTSD symptoms for at least six months. Participants must be military Veterans and medically stable, with no prior significant use of MDMA or classic psychedelics. The trial involves two dosing sessions: the first is double-blind, and the second is single-blind (participants blinded). During each session, MDMA is administered first, followed by psilocybin 30 minutes later. Although exact dosages have not been disclosed, both experimental and comparator groups will receive active drugs.

The trial aims to measure the incidence of adverse events, suicidal ideation, PTSD symptom severity, and quality of life over approximately 33 weeks. Secondary outcomes include overall clinical improvement and changes in daily functioning. The study began in June 2025 and is expected to conclude by June 2029. It is being conducted at the Johns Hopkins Center for Psychedelic and Consciousness Research in Baltimore, Maryland.

Topic PTSD
Compound Psilocybin MDMA
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 June 2025
End date 01 June 2029
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 40
Sex All
Age 21- 99
Therapy No

Trial Details

The proposed randomized, double-blind, active control study will compare a single experimental dose of co-administered MDMA + psilocybin (exact dosages not disclosed) with a single comparator dose of co-administered MDMA + psilocybin (exact dosages not disclosed). For the co-administered dosing session, MDMA will be given initially, followed by psilocybin 30 minutes later. Approximately 1.5 months after the first dosing session, a second single-blind (participant masked) dosing session will occur. The study will recruit adult Veterans with PTSD for ≥ 6 months.

Trial Number NCT06989957

Sponsors & Collaborators

Johns Hopkins University
Johns Hopkins University (Medicine) is host to the Center for Psychedelic and Consciousness Research, which is one of the leading research institutes into psychedelics. The center is led by Roland Griffiths and Matthew Johnson.

Data attribution

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