{"protocolSection":{"identificationModule":{"nctId":"NCT05520775","orgStudyIdInfo":{"id":"21-1689"},"secondaryIdInfos":[{"id":"R21AA026931-02","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R21AA026931-02"}],"organization":{"fullName":"University of North Carolina, Chapel Hill","class":"OTHER"},"briefTitle":"Semaglutide for Alcohol Use Disorder","officialTitle":"Human Laboratory Screening of Semaglutide for Alcohol Use Disorder"},"statusModule":{"statusVerifiedDate":"2024-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-09-02","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-04-12","type":"ACTUAL"},"completionDateStruct":{"date":"2024-04-19","type":"ACTUAL"},"studyFirstSubmitDate":"2022-08-26","studyFirstSubmitQcDate":"2022-08-26","studyFirstPostDateStruct":{"date":"2022-08-30","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-02-11","resultsFirstSubmitQcDate":"2025-03-21","resultsFirstPostDateStruct":{"date":"2025-03-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-03-25","lastUpdatePostDateStruct":{"date":"2025-04-02","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of North Carolina, Chapel Hill","class":"OTHER"},"collaborators":[{"name":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is an early-Phase II human laboratory trial using a randomized, placebo-controlled, dose-ranging design to investigate the effects of semaglutide, a GLP-1 receptor agonist, on alcohol-related outcomes in adults with alcohol use disorder (AUD).","detailedDescription":"This is an early-Phase II human laboratory trial using a randomized, placebo-controlled, dose-ranging design to investigate the effects of semaglutide, a GLP-1 receptor agonist, on laboratory alcohol responses and consumption, naturalistic alcohol consumption, and weight loss in participants with alcohol use disorder (AUD). Participants will attend weekly visits while semaglutide dosage is increased to 1.0mg over a period of approximately 9-10 weeks. Participants will attend weekly visits for medication or placebo administration. At scheduled intervals, participants will complete 4 laboratory sessions involving alcohol self-administration and alcohol challenge to characterize medication effects on alcohol-related outcomes."},"conditionsModule":{"conditions":["Alcohol Use Disorder","Cigarette Smoking"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"Randomized parallel group design.","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":48,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide","type":"EXPERIMENTAL","description":"Participants will receive semaglutide via subcutaneous injections at escalating doses (.25mg to 1.0mg) over 9 weeks.","interventionNames":["Drug: Semaglutide"]},{"label":"Sham/Placebo","type":"SHAM_COMPARATOR","description":"Participants will receive sham subcutaneous injections over 9 weeks.","interventionNames":["Drug: Sham/placebo"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Semaglutide (subcutaneous)","armGroupLabels":["Semaglutide"]},{"type":"DRUG","name":"Sham/placebo","description":"Sham subcutaneous injection","armGroupLabels":["Sham/Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Alcohol Consumed","description":"Estimated grams of ethanol consumed.","timeFrame":"Baseline (Week 0) to post-medication (Week 8)"},{"measure":"Change in Breath Alcohol Concentration","description":"Peak breath alcohol concentration following an alcohol self-administration procedure.","timeFrame":"Baseline (Week 0) to post-medication (Week 8)"}],"secondaryOutcomes":[{"measure":"Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)","description":"Seven questions from the Biphasic Alcohol Effects Scale used to collect self-reported feelings of stimulation during an alcohol challenge procedure. Possible responses are 0-10, 0 being \"not at all\" and 10 being \"extremely\". Scale score ranges from 0 to 70. Higher scores indicate greater stimulation effects.","timeFrame":"Baseline (Week 0) to post-treatment (Week 8)"},{"measure":"Change in Subjective Sedation (Biphasic Alcohol Effects Scale)","description":"Seven questions from the Biphasic Alcohol Effects Scale used to collect self-reported sedative effects during an alcohol challenge procedure. Possible responses are 0 \"not at all\" through 10 \"extremely\". Scale scores range from 0 to 70. Higher scores indicate greater sedative effects.","timeFrame":"baseline (Week 0) to post-medication (Week 8)"},{"measure":"Change in Alcohol Demand (Alcohol Purchase Task)","description":"The Alcohol Purchase Task is a 20-question self-report measure which asks participants about the number of drinks they would purchase and consume based at different monetary costs. Intensity scores reflect the number of drinks that would be purchased when cost is zero.","timeFrame":"Baseline (Week 0) to post-treatment (Week 8)"},{"measure":"Change in Cigarette Demand (Cigarette Purchase Task)","description":"Self-report cigarette demand as measured by the Cigarette Purchase Task. Intensity scores reflect the number of cigarettes that would be purchased when cost is zero.","timeFrame":"Baseline (Week 0) to Post-medication (Week 8)"},{"measure":"Change in Daily Alcohol Use","description":"Self-reported drinks per day averaged across study week.","timeFrame":"baseline (Week 0) to study endpoint (Week 10)"},{"measure":"Change in Daily Cigarette Use","description":"Self-reported cigarettes per day","timeFrame":"baseline (Week 0) to study endpoint (Week 10)"}],"otherOutcomes":[{"measure":"Change in Weight","description":"Change in Body weight","timeFrame":"baseline (Week 0) to study endpoint (Week 10)"},{"measure":"Change in HbA1c","description":"Hemoglobin A1C (HbA1c)","timeFrame":"baseline (Week 0) to study endpoint (Week 10)"},{"measure":"Change in Alcohol Elimination","description":"Rate of alcohol elimination following an alcohol challenge procedure","timeFrame":"baseline (Week 0) to post-medication (Week 8)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age 21-65\n* Meeting DSM-5 criteria for current (past year) alcohol use disorder (with 2-7 symptoms endorsed) and National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for current at-risk drinking (i.e., \\>7/14 drinks in one week for women/men, with at least two episodes of 4+/5+ drinks in the past 30 days)\n* Willingness/availability to take study medication and complete study procedures, including attending weekly visits for medication administration, side effect assessments, and glucose monitoring\n* Willingness to complete laboratory sessions involving alcohol administration\n* Ability to communicate and read in English\n\nExclusion Criteria:\n\n* Reporting past 30-day use of illicit drugs other than cannabis at baseline, or having a positive toxicology screen for illicit drugs other than cannabis at baseline\n* Meeting past-year criteria for a substance use disorder (with the exception of alcohol, tobacco or mild cannabis use disorder)\n* Current engagement in alcohol treatments, or currently engaged in intentional efforts to quit alcohol use\n* Past 30-day use of: Sincalide, Sulfonylureas, insulin and insulin products or other medications that may interact with semaglutide;, or weight control medications\n* Prior use of semaglutide or other GLP-1 agonists\n* Known or suspected hypersensitivity to study medication or related products\n* Lifetime diagnosis of severe mental illness (including schizophrenia and bipolar disorder)\n* History of suicide attempt, or recent (past 30 day) suicidal ideation, or psychiatric hospitalization in the last 6 months\n* Current significant medical or neurological illness (based on self-report or medical record) including severe hepatic impairment or cirrhosis, impaired renal function (eGFR \\<50ml/min), acute or chronic pancreatitis, gastroparesis, gallbladder disease or cholelithiasis, other severe gastrointestinal disease, heart failure, coronary artery disease, stroke, seizure disorder, or other medical condition that poses a risk for the medication or alcohol administration components of the study (as determined by the MD)\n* A personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B\n* Calcitonin greater than or equal to 50 ng/L\n* Uncontrolled thyroid disease at screening\n* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)\n* History of Type 1 or Type 2 diabetes, or HbA1c \\>6.5% measured at screening\n* History of diabetic retinopathy, proliferative retinopathy, or maculopathy\n* History of diabetic ketoacidosis\n* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)\n* Currently nursing, pregnant, anticipating pregnancy in the next 6 months, or not using a highly effective contraceptive method as judged by the MD, and defined as:\n\n  1. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)\n  2. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n  3. intrauterine device\n  4. intrauterine hormone-releasing system\n  5. bilateral tubal occlusion\n  6. vasectomized partner\n  7. sexual abstinence\n* Elevation of serum lipase, amylase, direct (conjugated) bilirubin, or alkaline phosphatase (ALP), ALT, or AST) more than 3X the upper limit of normal on baseline bloodwork\n* Baseline body mass index (BMI) \\<23kg/m\\^2\n* Uncontrolled hypertension or systolic BP \\>180 mmHg and/or diastolic BP \\>105 mmHg, averaged from three measurements\n* Plans for travel outside of the local area in the upcoming 12 weeks that would interfere with lab visits during the study period (or other logistic factors that would make it difficult to commit to entire duration of study)","healthyVolunteers":true,"sex":"ALL","minimumAge":"21 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Christian Hendershot, Ph.D.","affiliation":"UNC-Chapel Hill","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"UNC-Chapel Hill","city":"Chapel Hill","state":"North Carolina","zip":"27599","country":"United States","geoPoint":{"lat":35.9132,"lon":-79.05584}}]},"referencesModule":{"references":[{"pmid":"39937469","type":"DERIVED","citation":"Hendershot CS, Bremmer MP, Paladino MB, Kostantinis G, Gilmore TA, Sullivan NR, Tow AC, Dermody SS, Prince MA, Jordan R, McKee SA, Fletcher PJ, Claus ED, Klein KR. Once-Weekly Semaglutide in Adults With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Apr 1;82(4):395-405. doi: 10.1001/jamapsychiatry.2024.4789."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"IPD will be shared with other investigators upon reasonable request.","infoTypes":["STUDY_PROTOCOL","SAP","ICF","CSR","ANALYTIC_CODE"],"timeFrame":"Data will become available following publication of study manuscripts and will be available indefinitely.","accessCriteria":"Reasonable request from qualified investigator."}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Semaglutide","description":"Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.\n\nSemaglutide: Semaglutide (subcutaneous)"},{"id":"FG001","title":"Sham/Placebo","description":"Participants will receive sham subcutaneous injections over 9 weeks.\n\nSham/placebo: Sham subcutaneous injection"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"24"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"19"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"5"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Semaglutide","description":"Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.\n\nSemaglutide: Semaglutide (subcutaneous)"},{"id":"BG001","title":"Sham/Placebo","description":"Participants will receive sham subcutaneous injections over 9 weeks.\n\nSham/placebo: Sham subcutaneous injection"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"48"}]}],"measures":[{"title":"Age, Categorical","description":"Demographics Questionnaire","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"48"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","description":"Demographics Questionnaire","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"40.6","spread":"10.5"},{"groupId":"BG001","value":"39.0","spread":"10.9"},{"groupId":"BG002","value":"39.9","spread":"10.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"34"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"14"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"44"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"7"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"39"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"48"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Alcohol Consumed","description":"Estimated grams of ethanol consumed.","populationDescription":"Participants who completed pre- and post-treatment laboratory self-administration.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"grams","timeFrame":"Baseline (Week 0) to post-medication (Week 8)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.\n\nSemaglutide: Semaglutide (subcutaneous)"},{"id":"OG001","title":"Sham/Placebo","description":"Participants will receive sham subcutaneous injections over 9 weeks.\n\nSham/placebo: Sham subcutaneous injection"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-32.72","spread":"27.98"},{"groupId":"OG001","value":"-6.95","spread":"24.49"}]}]}]},{"type":"PRIMARY","title":"Change in Breath Alcohol Concentration","description":"Peak breath alcohol concentration following an alcohol self-administration procedure.","populationDescription":"Participants who completed pre- and post-treatment laboratory self-administration.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"g/dl","timeFrame":"Baseline (Week 0) to post-medication (Week 8)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants will receive semaglutide via subcutaneous injections at escalating doses (.25mg to 1.0mg) over 9 weeks.\n\nSemaglutide: Semaglutide (subcutaneous)"},{"id":"OG001","title":"Sham/Placebo","description":"Participants will receive sham subcutaneous injections over 9 weeks.\n\nSham/placebo: Sham subcutaneous injection"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.034","spread":"0.045"},{"groupId":"OG001","value":"-0.016","spread":"0.047"}]}]}]},{"type":"SECONDARY","title":"Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)","description":"Seven questions from the Biphasic Alcohol Effects Scale used to collect self-reported feelings of stimulation during an alcohol challenge procedure. Possible responses are 0-10, 0 being \"not at all\" and 10 being \"extremely\". Scale score ranges from 0 to 70. Higher scores indicate greater stimulation effects.","populationDescription":"Participants with pre- and post-treatment data from an alcohol challenge laboratory session.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Baseline (Week 0) to post-treatment (Week 8)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.\n\nSemaglutide: Semaglutide (subcutaneous)"},{"id":"OG001","title":"Sham/Placebo","description":"Participants will receive sham subcutaneous injections over 9 weeks.\n\nSham/placebo: Sham subcutaneous injection"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"18"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":".45","spread":"12.82"},{"groupId":"OG001","value":"-1.28","spread":"13.49"}]}]}]},{"type":"SECONDARY","title":"Change in Subjective Sedation (Biphasic Alcohol Effects Scale)","description":"Seven questions from the Biphasic Alcohol Effects Scale used to collect self-reported sedative effects during an alcohol challenge procedure. Possible responses are 0 \"not at all\" through 10 \"extremely\". Scale scores range from 0 to 70. Higher scores indicate greater sedative effects.","populationDescription":"Participants with pre- and post-treatment data from an alcohol challenge laboratory session.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"baseline (Week 0) to post-medication (Week 8)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.\n\nSemaglutide: Semaglutide (subcutaneous)"},{"id":"OG001","title":"Sham/Placebo","description":"Participants will receive sham subcutaneous injections over 9 weeks.\n\nSham/placebo: Sham subcutaneous injection"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"18"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.14","spread":"10.69"},{"groupId":"OG001","value":"-3.22","spread":"7.89"}]}]}]},{"type":"SECONDARY","title":"Change in Alcohol Demand (Alcohol Purchase Task)","description":"The Alcohol Purchase Task is a 20-question self-report measure which asks participants about the number of drinks they would purchase and consume based at different monetary costs. 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Intensity scores reflect the number of cigarettes that would be purchased when cost is zero.","populationDescription":"Participants who reported cigarette use at baseline and provided pre- and post-treatment cigarette demand data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"number of cigarettes","timeFrame":"Baseline (Week 0) to Post-medication (Week 8)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.\n\nSemaglutide: Semaglutide (subcutaneous)"},{"id":"OG001","title":"Sham/Placebo","description":"Participants will receive sham subcutaneous injections over 9 weeks.\n\nSham/placebo: Sham subcutaneous 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