Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PT
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
| Condition(s) | Posttraumatic Stress Disorder |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: * \>=21 years old * Military Veteran * Have given written informed consent * Able to swallow pills * Have a confirmed DSM-5 diagnosis of Post-traumatic Stress Disorder with symptom duration \>= 6 months * Have a baseline CAPS-5 score of \>=28 * Be judged by study team clinicians to be at low acute risk for suicidality * Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study. * Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests * Agree to consume appr |
| Ages | 21 Years |
| Sex | All |
| Lead sponsor | Johns Hopkins University |
| Locations | Baltimore, Maryland, United States |
| Start date | 2025-09-17 |
| NCT ID | NCT06989957 |
| Official listing | https://clinicaltrials.gov/study/NCT06989957 |