MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers and First Responders (NCT05455996) | Clinical Trial Compass
Not Yet RecruitingPhase 2
MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers and First Responders
United States30 participantsStarted 2026-10
Plain-language summary
The purpose of this study is to assess the safety and efficacy of MDMA-Assisted Therapy on Frontline Health Care Workers and First Responders suffering from symptoms of Post-Traumatic Stress.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Were exposed to stressors related to their work in a health care setting or emergency response system
* Are fluent in speaking and reading English.
* Are able to swallow pills.
* Agree to have study visits recorded, including Experimental Sessions, and non-drug therapy sessions.
* Have a contact (relative, spouse, close friend or other Support Person) who is willing and able to be reached by the Sponsor-Investigators in the event of a participant becoming suicidal or unreachable.
* Agree to inform the Sponsor-Investigators within 48 hours of any medical conditions and procedures.
* If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
* Comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, be driven home after Experimental Sessions, and commit to medication dosing, therapy, and study procedures.
Exclusion Criteria:
* Have previously participated in a clinical treatment trial using MDMA.
* Have a past diagnosis of PTSD unrelated to their work in the healthcare or emergency response systems.
* Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
* Have a history of or a current primary psychotic disorder or bipolar I disord…
What they're measuring
1
Change from Baseline on symptoms of Post-Traumatic Stress based on the PTSD Checklist for DSM-5 (PCL-5) at Treatment Termination
Timeframe: Up to 17 weeks post-enrollment (Baseline)