Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05455996 | MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers and First Responders | PHASE2 | NOT YET_RECRUITING | 30 | — | — | Oct 1, 2026 | Jun 1, 2028 | May 5, 2026 | 3 | United States |
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD and is widely used by researchers and clinicians to monitor change during and after a treatment intervention. Participants indicate how much distress they have experienced due to symptoms such as "Repeated, disturbing memories, thoughts, or images of a stressful experience from the past," "Trouble remembering important parts of a stressful experience from the past," and "Feeling irritable or having angry outbursts" using a Likert scale ranging from 0 (Not at all) to 4 (Extremely). Items are summed to provide a total severity score (range = 0-80). It takes 5-10 minutes to complete.
| Arm | Type | Description |
|---|---|---|
| MDMA-assisted therapy | EXPERIMENTAL | Participants will receive 3-dosing model of MDMA-assisted therapy (includes 9 non-drug therapy sessions) |
| Name | Type | Description |
|---|---|---|
| MDMA | DRUG | MDMA-assisted therapy |
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 session...