[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613374":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":52,"studyPopulation":39,"armGroups":53,"interventions":66,"overallOfficials":75,"centralContacts":79,"locations":39,"responsibleParty":85,"collaborators":39,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":39,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":39,"enrollmentInfo":97,"targetDuration":39,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":107,"whyStopped":39,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":39},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Cue-Induced Craving","Craving scores will be assessed using a cue-reactivity paradigm in which participants are exposed to cannabis\\]-related cues. Scores range from 0 to 30, with higher scores indicating greater craving intensity.","5 weeks",[14,17,20,23,25,28,30,33,36],{"measure":15,"description":16,"timeFrame":12},"Serious adverse event","Incidence of serious adverse events",{"measure":18,"description":19,"timeFrame":12},"Cravings","Cannabis craving scale using the 12-item questionnaire, each item scored on a 1-7 sale. Higher scores (either average or summed) indicates stronger cravings.",{"measure":21,"description":22,"timeFrame":12},"Abstinence","Percent days abstinent from cannabis",{"measure":24,"description":24,"timeFrame":12},"Weight",{"measure":26,"description":27,"timeFrame":12},"Blood sugar","Blood glucose",{"measure":29,"description":29,"timeFrame":12},"Hemoglobin A1c",{"measure":31,"description":32,"timeFrame":12},"Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8)","Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8). The PHQ-8 assesses depression severity over the past two weeks. Total scores range from 0 to 24, with higher scores indicating greater depression severity (worse outcome). Score interpretation: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), 20-24 (severe depression).",{"measure":34,"description":35,"timeFrame":12},"Anxiety severity as measured by the Generalized Anxiety Disorder-7 scale (GAD-7)","The GAD-7 assesses anxiety symptom severity over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity (worse outcome). Score interpretation: 0-4 (minimal anxiety), 5-9 (mild), 10-14 (moderate), 15-21 (severe anxiety).",{"measure":37,"description":38,"timeFrame":12},"Suicidality as measured by the C-SSRS (Columbia-Suicide Severity Rating Scale)","The C-SSRS assesses the presence and severity of suicidal ideation and behavior. Suicidal ideation severity scores range from 0 to 5 (0=no ideation, 1=wish to be dead, 2=non-specific active suicidal thoughts, 3=active suicidal ideation with methods, 4=suicidal intent, 5=suicidal intent with plan), with higher scores indicating greater severity (worse outcome). The scale also captures suicidal behavior as binary yes\u002Fno responses.",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":45,"maskingDescription":46,"whoMasked":47},"QUADRUPLE","Double-blind placebo-controlled",[48,49,50,51],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder. Eligible participants will be scheduled in random order to receive either tirzepatide or placebo injection in double-blind fashion and cross-over design. Outcomes will be assessed at the following study visit. Washout period of at least 4 weeks will be required between tirzepatide or placebo injections. Primary outcome of interest is cue-induced craving to cannabis-related visual cues.",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"tirzepatide","EXPERIMENTAL","2.5mg subcutaneous injection once",[59],"Drug: Tirzepatide",{"label":61,"type":62,"description":63,"interventionNames":64},"placebo","PLACEBO_COMPARATOR","matching placebo subcutaneous injection once",[65],"Drug: Placebo",[67,71],{"type":68,"name":69,"description":57,"armGroupLabels":70,"otherNames":39},"DRUG","Tirzepatide",[55],{"type":68,"name":72,"description":73,"armGroupLabels":74,"otherNames":39},"Placebo","Saline placebo subcutaneous injection once",[61],[76],{"name":77,"affiliation":5,"role":78},"Joji Suzuki","PRINCIPAL_INVESTIGATOR",[80],{"name":81,"role":82,"phone":83,"phoneExt":39,"email":84},"Mary R Shen, MD","CONTACT","6177325752","mshen4@bwh.harvard.edu",{"type":78,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Joji Suzuki, MD","Principal Investigator, Division of Addiction Treatment and Prevention, AMC Psychiatry Mass General Brigham","100613374","phase-2-tirzepatide-for-the-treatment-of-cannabis-use-disorder-100613374",false,"NCT07265752","Tirzepatide for the Treatment of Cannabis Use Disorder","Tirzepatide for the Treatment of Cannabis Use Disorder: A Pilot Double-blind, Placebo-controlled, Crossover Trial","Inclusion Criteria:\n\n* English speaking adults aged 18 and above\n* Diagnosed with DSM-5 cannabis use disorder, severe\n\nExclusion Criteria:\n\n* Active psychosis, active suicidality or homicidality or any psychiatric condition that impair ability to provide informed consent\n* Any current or lifetime diagnosis of eating disorders including anorexia, bulimia, binge eating or\n* Comorbid substance use disorder\n* BMI\\\u003C21 kg\u002Fm2\n* Current or lifetime diagnosis of Type 1 or Type 2 diabetes\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2\n* Use of any glucagon-like peptide -1 agonist medications in the prior 3 months\n* Anticipating receipt of any glucagon-like peptide-1 agonist medications during the trial\n* Current hypoglycemia as indicated by a blood sugar level of \\\u003C71 mg\u002FdL measured at baseline visit, as well as visits 2 and 4.\n* Untreated cholelithiasis or gallbladder disease\n* History of acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or congestive heart failure in the last 90 days\n* Systolic blood pressure persistently above 160 mmHg or diastolic blood pressure persistently above 100 mmHg during screening\n* History of inflammatory bowel disease, bariatric surgery, pancreatitis, diabetic gastroparesis, or non-arteritic anterior ischemic optic neuropathy\n* Liver function test greater than 3 times upper normal limit\n* Renal impairment as indicated by estimated glomerular filtration rate (eGFR) of \\\u003C30\n* History of hypersensitivity or allergy to tirzepatide\n* Pregnant or breastfeeding\n* Individuals taking glucagon-like peptide-1 agonists or other weight loss drugs.\n* Anticipated to participate in a concurrent drug trial\n* Any other reason or clinical condition that the investigators judge may interfere with study participation and\u002For be unsafe for a participant","ALL","18 Years",{"count":98,"type":99},6,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder.",[105],"Cannabis Use Disorder",[55],"NOT_YET_RECRUITING","2026-10-07",{"date":110,"type":111},"2026-10-09","ACTUAL",{"date":113,"type":99},"2027-03-01",{"date":115,"type":99},"2028-06-30",{"name":5,"class":6}]