Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-26 @ 8:48 AM
Study NCT ID:
NCT07040592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-30
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants who complete enrollment and duration of sessions', 'timeFrame': '12 weeks', 'description': 'Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study'}, {'measure': 'Number of sessions completed', 'timeFrame': '12 weeks', 'description': 'Number of sessions completed to assess acceptability of study'}, {'measure': 'Adherence to Medication', 'timeFrame': '12 weeks', 'description': 'Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study'}, {'measure': 'Safety of study assessed by adverse event reporting', 'timeFrame': '12 weeks', 'description': 'Safety will be assessed by the percentage of study participants who report adverse events.'}], 'secondaryOutcomes': [{'measure': 'Efficacy of study - change in self-reported alcohol use', 'timeFrame': '12 weeks', 'description': 'Change in self-reported alcohol use (# of days of alcohol use and # of drinks per day) on the Timeline Followback.'}, {'measure': 'Efficacy of study - change in PEth (phosphatidylethanol) results', 'timeFrame': '12 weeks', 'description': 'PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder (AUD)', 'HIV']}, 'descriptionModule': {'briefSummary': 'This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.', 'detailedDescription': 'This is a series of three open-label pilot studies that consist of a 12-week intervention including off-label use of medication with MM and a clinical pharmacist-delivered behavioral intervention to treat AUD. Participants will receive counseling that incorporates brief feedback and advice with motivational enhancement techniques to assist the participant in changing their behaviors with respect to alcohol consumption and/or polypharmacy defined as taking five or more medications, particularly if those medications interact with alcohol.\n\nIn addition, participants will be offered semaglutide in the third pilot study. The rationale for utilizing an open-label pilot study design is to determine the feasibility, acceptability, safety, and preliminary efficacy of this intervention for the management of AUD. Participants will be interviewed with regards to their perspectives on feasibility and acceptability. They will be instructed to have medication bottles at study visits to assess medication adherence and will be assessed with readiness to change metrics and questions regarding quantity and frequency of alcohol use. Patients will also be asked to complete an AUDIT-C screen and the Alcohol Symptom Checklist at the start of the study period to screen for mild, moderate, or severe AUD. Several assessments including interviews and laboratory testing will be done at study visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with HIV\n* Receive care at the Atlanta VA Healthcare System\n* Age 18 or over\n* Meet criteria for mild, moderate, or severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen\n* Have evidence of significant alcohol use: PEth \\> 20ng/ml\n* Prescribed \\>=5 medications\n* Have cell phone or reliable contact number\n* Can provide written informed consent\n\nExclusion Criteria:\n\n* Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment\n* Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive\n* Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits participation (including current or past intent to harm oneself or others within the prior 12 months and not receiving treatment)\n* Untreated moderate to severe opioid use disorder\n* Residence out of state\n* Inability to read or understand English\n* History of serious hypersensitivity or adverse reaction to study medication\n* Taking potentially interactive medication(s) for diabetes\n* BMI\\<23\n* Diagnosis of type 1 Diabetes\n* Personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2, Severe gastrointestinal dysmotility, including gastroparesis, History of pancreatitis (does not pertain to patients for whom the cause of pancreatitis is known and no longer presents a risk), severe gallbladder disease\n* Known Proliferative Diabetic Retinopathy, severe Non-Proliferative Diabetic Retinopathy, clinically significant Macular Edema, or Cystoid Macular Edema\n* Already prescribed the pilot medication at the time of study recruitment.'}, 'identificationModule': {'nctId': 'NCT07040592', 'acronym': 'HARP', 'briefTitle': 'Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Feasibility, Acceptability, and Preliminary Efficacy of Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: An Open-Label Pilot Study', 'orgStudyIdInfo': {'id': '2000033919_c'}, 'secondaryIdInfos': [{'id': '1P01AA029545-01', 'link': 'https://reporter.nih.gov/quickSearch/1P01AA029545-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide', 'description': 'Participants will receive a prescription for semaglutide.', 'interventionNames': ['Drug: semaglutide']}], 'interventions': [{'name': 'semaglutide', 'type': 'DRUG', 'description': 'All participants will receive a prescription for semaglutide and will meet with a clinical pharmacist and addiction psychiatrist for further support', 'armGroupLabels': ['Semaglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'contacts': [{'name': 'Julie Costello', 'role': 'CONTACT', 'email': 'julie.costello2@va.gov', 'phone': '404-321-6111 Ext. 203875'}, {'name': 'Vincent Marconi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atlanta VA Medical Center', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}], 'centralContacts': [{'name': 'E. Jennifer Edelman, MD, MHS', 'role': 'CONTACT', 'email': 'ejennifer.edelman@yale.edu', 'phone': '203-737-7115'}, {'name': 'June-Marie Weiss, MA, MEd', 'role': 'CONTACT', 'email': 'junemarie.weiss@yale.edu', 'phone': '203-737-3347'}], 'overallOfficials': [{'name': 'E. Jennifer Edelman, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}