NCT06989957

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD). To apply or learn more, please view our website: https://hopkinspsychedelic.org/pamvet

Detailed description

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.

Conditions

• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Psilocybin	Experimental Psilocybin (exact dosages not disclosed)
DRUG	Psilocybin	Comparator Psilocybin (exact dosages not disclosed)
DRUG	MDMA	Experimental MDMA (exact dosages not disclosed)
DRUG	MDMA	Comparator MDMA (exact dosages not disclosed)

Timeline

• Start date: 2025-09-17
• Primary completion: 2028-08-01
• Completion: 2029-08-01
• First posted: 2025-05-25
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study