[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631354":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":67,"collaborators":28,"id":70,"slug":28,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":28,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":28,"studyType":81,"phases":82,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":94,"whyStopped":28,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Psilocybin Dose - Low","EXPERIMENTAL","Experimental: Participants receive a single oral dose of psilocybin 5mgs",[13],"Drug: Psilocybin",{"label":15,"type":10,"description":16,"interventionNames":17},"Psilocybin Dose - Moderate","Experimental: Participants receive a single oral dose of psilocybin 10mgs",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Psilocybin Dose - High","Experimental: Participants receive a single oral dose of psilocybin 25mgs",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Psilocybin","Participants will be randomly administered a single dose of either 5mg or 10mg or 25mg psilocybin",[19,9,15],null,[30],{"name":31,"affiliation":5,"role":32},"Susan K Conroy, PhD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Susan K Conroy, MD","CONTACT","317-948-5450","sconroy@iu.edu",{"name":40,"role":36,"phone":41,"phoneExt":28,"email":42},"Helen C Fox, PhD","203-671-9643","helfox@iu.edu",[44,61],{"facility":45,"status":28,"city":46,"state":47,"zip":48,"country":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Goodman Hall, Dept of Psychiatry, Indiana University","Indianapolis","Indiana","46202-3082","United States",{"type":51,"coordinates":52},"Point",[53,54],-86.15804,39.76838,{"lat":54,"lon":53},[57,58],{"name":35,"role":36,"phone":28,"phoneExt":28,"email":38},{"name":59,"role":36,"phone":60,"phoneExt":28,"email":42},"Helen Fox, PhD","2036719643",{"facility":62,"status":28,"city":46,"state":47,"zip":63,"country":49,"cosmosGeoPoint":64,"geoPoint":66,"contacts":28},"The Stark Neuroscience Building (Goodman Hall)","46202",{"type":51,"coordinates":65},[53,54],{"lat":54,"lon":53},{"type":32,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Susan K. Conroy","Assitant Professor of Psychiatry","100631354",false,"NCT07499583","Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder","Inclusion Criteria:\n\ni) Veterans or first responders ii) 18 -70 years of age iii) Meets criteria for TRD (current major depressive episode without psychotic features by the Mini-International Neuropsychiatric Interview - MINI, with failure to respond to 2 or more evidence-based anti-depressants in the current episode), iv) Meets moderate to severe use criteria for one primary substance (alcohol, cocaine, opioids\u002Fheroin, or cannabis). Moderate to severe co-use of nicotine also acceptable, as well as mild\u002Frecreational use of other substances, v) Able to read English and complete study evaluations and consent vi) In good health as verified by screening examination and medical history vii) able to safely receive MRI\n\nExclusion Criteria:\n\ni) Exclusionary psychiatric conditions include schizophrenia, schizoaffective disorder, bipolar disorder, current post-traumatic stress disorder, or history of medically serious suicide attempt ii) Actively\u002Fimminently suicidal (QIDS-SR question 12 score \\>2, Hamilton - depression scale (HAM-D) question 3 score \\>3, or Montgomery-Åsberg Depression Rating Scale (MADRS) question 10 \\>4) ii) A family history of schizophrenia or schizoaffective disorder (first- or second-degree relatives), or bipolar disorder type 1 (first degree relatives) iii) Use of selective serotonin reuptake inhibitors (SSRIs) and other medications are acceptable if dose has remained stable for 6 months, and is not contra-indicated with psilocybin, as per the study physician, Dr Conroy iii) Individuals with any prior use of classic psychedelics, including psilocybin iv) Medical conditions that would preclude safe participation in the trial (e.g., seizure disorder, significantly impaired liver function, coronary artery disease, heart failure, history of cerebrovascular accident, severe asthma, hyperthyroidism, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction) v) Sitting blood pressure below 90\u002F50 mmHG or above 165\u002F95 mmHg vi) EKG evidence of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) of \\>450 msec for men and QTc\\>470 msec for women vii) Women who are pregnant or lactating","ALL","18 Years","70 Years",{"count":79,"type":80},50,"ESTIMATED","INTERVENTIONAL",[83,84],"PHASE1","PHASE2","The goal of this clinical trial is to learn if a single dose of psilocybin (5mg Vs 10mg Vs 25mg) alongside psychotherapy is safe and can help treat treatment resistant depression (TRD) with co-occurring substance use disorder (SUD) in veterans and first responders. We seek to answer:\n\n* Whether 5mgs, 10mgs and 25mgs of psilocybin are safe in individuals with co-occurring TRD and SUD\n* Whether psilocybin assisted psychotherapy will reduce substance use severity and depression symptoms\n* What neurobiological processes are associated with the effects of psilocybin assisted psychotherapy.\n\nThe researchers will compare the effects of a single dose of psilocybin (either 5mgs or 10mgs or 25mg) alongside psychotherapy on substance use severity and depression symptoms over six weeks in veterans and first responders with TRD and co-occurring SUD.\n\nIn this 14-week study, participants will:\n\n* Visit the clinic for two intake sessions\n* Complete seven psychotherapy sessions. This will include three sessions before psilocybin administration, an 8 to 10 hour dosing session, and three sessions following psilocybin administration\n* Complete short, repeated daily assessments for six weeks, in total, before and after psilocybin administration\n* Complete two brain scans before and after psilocybin administration",[87,88],"Treatment Resistant Depression","Substance Use Disorders",[90,91,92,93],"treatment resistant depression","substance abuse disorder","psilocybin assisted psychotherapy","stress","NOT_YET_RECRUITING","2026-03-24",{"date":97,"type":98},"2026-03-30","ACTUAL",{"date":100,"type":80},"2026-08-01",{"date":102,"type":80},"2031-02-28",{"name":5,"class":6},2]