[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636705":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":28,"locations":37,"responsibleParty":56,"collaborators":11,"id":58,"slug":11,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":11,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":11,"overallStatus":40,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Sunstone Medical","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Individual","EXPERIMENTAL",null,[13],"Drug: MDMA",{"label":15,"type":10,"description":11,"interventionNames":16},"Group",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","MDMA","MDMA is a ring-substituted phenylisopropylamine derivative invented by the Merck pharmaceutical company in 1912.",[15,9],[24],{"name":25,"affiliation":26,"role":27},"Manish Agarwal","Sunstone Medical, PC","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Clinical Evaluation Team","CONTACT","(301) 750-3401","clinical.specialists@sunstonetherapies.com",{"name":35,"role":31,"phone":11,"phoneExt":11,"email":36},"Kalisha Watkins","kalisha.watkins@sunstonetherapies.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Sunstone Therapies","RECRUITING","Rockville","Maryland","20850","United States",{"type":46,"coordinates":47},"Point",[48,49],-77.15276,39.084,{"lat":49,"lon":48},[52,53],{"name":25,"role":27,"phone":11,"phoneExt":11,"email":11},{"name":54,"role":55,"phone":11,"phoneExt":11,"email":11},"Michelle Leff","SUB_INVESTIGATOR",{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100636705",false,"NCT07569159","MDMA Therapy in Veterans With PTSD","A Phase 2, Open-Label Study Investigating the Safety and Efficacy of MDMA-Assisted Therapy for Veterans With Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* Veterans who are at least 18 years old\n* Are able to swallow pills\n* Are able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.\n* Proficient in speaking and reading English.\n\nExclusion Criteria:\n\n* Condition impairing oral intake or digestive absorption.\n* Unable to give adequate informed consent.\n* Significant suicide risk as defined by suicidal ideation with intend and plan as endorsed on items 5 on C-SSRS within the past 3 months\n* Cardiovascular disease, including, but not limited to, coronary artery disease (CAD) and chronic heart failure (CHF)\n* A history of, or a current primary schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.\n* Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.\n* Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.","ALL","18 Years",{"count":67,"type":68},52,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.",[74],"Post Traumatic Stress Disorder","2026-06-30",{"date":77,"type":78},"2026-07-01","ACTUAL",{"date":75,"type":68},{"date":81,"type":68},"2027-08",{"name":5,"class":6},1]