[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600829":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":29,"locations":35,"responsibleParty":59,"collaborators":20,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":20,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":20,"enrollmentInfo":72,"targetDuration":20,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Open-Label","EXPERIMENTAL","One session of MDMA-Assisted Therapy",[13],"Drug: MDMA Hydrochloride",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","MDMA Hydrochloride","Initial dose of 120 mg MDMA HCl in a therapeutic setting, followed 1.5 to 2 hours later by a supplemental dose of 40 mg MDMA HCl. Supplemental doses may be withheld if tolerability issues emerge or it is declined by the participant.",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Tamar Glatman Zaretsky","Mount Sinai Icahn School of Medicine","STUDY_DIRECTOR",{"name":27,"affiliation":24,"role":28},"Rachel Yehuda","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":20,"email":34},"Lily Fischer","CONTACT","862-253-1938","therapistwellbeing@mssm.edu",[36],{"facility":37,"status":38,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The Parsons Research Center for Psychedelic Healing","RECRUITING","New York","10025","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-74.00597,40.71427,{"lat":47,"lon":46},[50,54,57],{"name":51,"role":32,"phone":52,"phoneExt":20,"email":53},"Tamar Glatman Zaretsky, PsyD","(914) 340-3669","tamar.glatmanzaretsky@mssm.edu",{"name":55,"role":32,"phone":56,"phoneExt":20,"email":34},"Lily Fischer, MSc","‪(862) 253-1938‬",{"name":58,"role":28,"phone":20,"phoneExt":20,"email":20},"Rachel Yehuda, PhD",{"type":60,"investigatorFullName":27,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Professor","100600829","phase-1-mdma-assisted-therapy-for-mental-healthcare-providers-100600829",false,"NCT07102576","MDMA-Assisted Therapy for Mental Healthcare Providers","A Phase 1, Open-Label Study to Assess Psychological and Biological Effects of MDMA Assisted Therapy When Administered to Mental Health Providers in Training to be MDMA-Assisted Therapists","Inclusion Criteria:\n\n* Are at least 18 years at the time of signing the informed consent.\n* Fluent in English\n* Able to swallow pills\n* Agree to have study visits audiovisually recorded\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* Must be licensed, license-eligible, or trainees in a relevant healthcare\u002Fmental health profession\n* Must be learning or have been certified to conduct MDMA-assisted therapy through the Lykos MDMA-Assisted Therapy Training program or authorized affiliate program\n* Body weight of at least 45 kilograms (kg; or 100 pounds (lbs)).\n\nExclusion Criteria\n\n* Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment\n* Have a current alcohol or cannabis use disorder of any severity within the 12 months prior to enrollment\n* Have a substance use disorder of any severity within 12 months prior to enrollment\n* Any suicidal ideation within the last 6 months\n* Repetitive or recent use of Ecstasy\u002FMDMA\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\n* Meet diagnostic criteria for a Major Depressive Episode currently or within the prior 3 months or meet diagnostic criteria for a current anxiety disorder assessed\n* Have a current eating disorder with compensatory behaviors\n* Have a history of, or a current primary psychotic disorder or bipolar disorder\n* Previous participation in a clinical trial that included administration of MDMA\n* Individuals in a personal relationship with the site investigator\n* Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception",true,"ALL","18 Years",{"count":73,"type":74},30,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","This is a phase 1, open-label study to assess changes in mental well-being following MDMA administration within a therapeutic setting, in mental health providers who are in training to become MDMA assisted therapists. Secondary outcome measures will examine the effects on provider burnout, provider self-efficacy, mood, self-compassion, quality of life, and other psychological factors. Participants will work with a co-therapy pair as they engage in a preparatory session, one experimental session with MDMA, and an integration session the following day.",[80],"Mental Wellbeing",[82,83,84,85,86],"Psychedelic Therapy","MDMA","MDMA-Assisted Therapy","Mental Health","Therapist","2026-03-26",{"date":89,"type":90},"2026-03-27","ACTUAL",{"date":92,"type":90},"2026-02-11",{"date":94,"type":74},"2029-12-21",{"name":27,"class":6},1]