NCT05455996

MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers

An Open Label Study to Treat Post-Traumatic Stress in COVID-19 Healthcare Workers Using MDMA-Assisted Therapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nautilus Sanctuary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of MDMA-Assisted Therapy on Health Care Workers suffering from symptoms of Post-Traumatic Stress due to their work on the frontline of the COVID Pandemic.

Detailed description

After being informed about the study and potential risks, screening participants who sign the Informed Consent form will go through multiple screening visits (onsite and remote) designed to assess psychiatric and medical appropriateness for the study treatment. Tapering of certain medications are required. The screening period takes between 3 to 7 weeks and includes two preparatory sessions (90 minutes each) with the participant's assigned therapy team. Once a screening participant is deemed eligible for the study, baseline measures of symptomatology are obtained and a third preparatory session is conducted. The participant then enters into the Active Treatment Period which begins with the first of three all-day dosing sessions followed by three 90-minute integration (non-drug) sessions scheduled approximately a week and a half apart. Approximately 3 to 5 weeks after the first dosing session, a second all-day dosing session takes place, followed again by three 90-minute integration (non-drug) sessions scheduled about a week and a half apart. Approximately 3 to 5 weeks after the second dosing session, a third all-day dosing session takes place, followed again by three 90-minute integration (non-drug) sessions scheduled about a week and a half apart. The total time to complete the Active Treatment Phase is between 6 and 16 weeks. Two to four weeks after the Active Treatment Phase, participants will meet with therapy team for a Treatment Termination Visit during which participants will complete primary outcome measures. Twelve months later, participants will be contacted and asked to repeat study measures to assess durability of effects. From Screening to Treatment Termination, participation in the study takes between 11 and 33 weeks. Some non-drug sessions can be done remotely at the discretion of the therapy team.

Conditions

• Post-Traumatic Stress Disorder
• Adjustment Disorders

Interventions

Type	Name	Description
DRUG	MDMA	MDMA-assisted therapy

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2022-07-13
• Last updated: 2025-11-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study