[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Stephen Robert Marder\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100499975","phase-2-mdma-assisted-therapy-for-veterans-with-moderate-to-severe-post-traumatic-stress-disorder-100499975",false,"NCT05790239","MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder","A Randomized, Double-Blind, Single-Site Phase II 2-Arm Study to Compare the Safety and Preliminary Efficacy of Manualized MDMA-Assisted Therapy to Low Dose D-Amphetamine Assisted Therapy in Veterans For The Treatment of Moderate to Severe PTSD","Inclusion Criteria:\n\n* At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months.\n* Fluent in speaking and reading the predominantly used or recognized language of the study site (English).\n* Must be a veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area.\n* Able to swallow pills.\n* Agree to have study visits audiovisually recorded, including Experimental Sessions, IR assessments, and non-drug therapy sessions.\n* Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable.\n* Able to identify appropriate support person(s) to stay with the participant on the evenings of Experimental Sessions if needed.\n* May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease.\n* May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.\n* Body weight of at least 45 kilograms (kg). Participants with a body weight of 45-48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg\u002Fm2. BMI must be within 18 to 32 kg\u002Fm2 (inclusive).\n* A person able to be pregnant (PABP) must use a highly effective contraceptive method.\n\nExclusion Criteria:\n\n* Are not able to give adequate informed consent.\n* Have evidence or history of significant medical or psychiatric disorders.\n* Are abusing illegal drugs.\n* Unable or unwilling to safely taper off prohibited psychiatric medication.\n* Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.",[26],"Post Traumatic Stress Disorder",[28,26,29,30,31,32,33],"MDMA","PTSD","Functional Impairment","Veteran","Substance Use Disorder","Chronic Pain","RECRUITING","2026-08-17",{"date":37,"type":38},"2026-08-19","ACTUAL",{"date":40,"type":38},"2025-03-01",{"date":42,"type":20},"2028-03-01",{"name":44,"class":45},"Stephen Robert Marder","FED",2,""]