Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 6:01 PM
Study NCT ID:
NCT01377168
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2011-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
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': 'D009271', 'term': 'Naltrexone'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-14', 'studyFirstSubmitDate': '2011-06-17', 'studyFirstSubmitQcDate': '2011-06-17', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV Viral Load Suppression', 'timeFrame': '6 months', 'description': 'The primary outcome will be the proportion with a VL\\<400 copies/mL at 6 months.'}], 'secondaryOutcomes': [{'measure': 'ART Compliance and Alcohol Use Behavior', 'timeFrame': '6 months', 'description': 'Secondary HIV outcomes will include time to ART initiation, retention on ART over 6 months, and HIV sexual risk behaviors. Alcohol use outcomes include the following: 1) Time to relapse to heavy drinking (for men defined as \\>5 drinks/drinking day); 2) percent of days drinking (PDD) over the six-month examination period; 3) percent of days abstinent (PDA) over the six month examination period; and 4) alcohol craving using the Obsessive Compulsive Drinking Scale where a mean change in total score will be assessed and compared between treatment groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV', 'Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': 'This study will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be randomized to receive either oral naltrexone for the treatment of alcohol use disorder or placebo. Men with acute, recent or established HIV infection will receive antiretroviral treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study is to see whether use of oral naltrexone improves medication compliance, and therefore HIV viral load suppression, among men with alcohol use disorder. The study will also assess the impact of oral naltrexone on alcohol use behaviors in this population.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets DSM-IV criteria for alcohol dependence or problem drinking.\n* Age 18 years and older\n* Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.\n* No participation in pharmacotherapy trial in the previous 30 days\n* Not pregnant\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Verbally or physically threatening to research staff\n* Unable to communicate in Spanish\n* Pending trials for a felony\n* Childs-Pugh Class C Cirrhosis\n* Grade 3 Hepatitis (LFTs \\> 5X normal)\n* Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.'}, 'identificationModule': {'nctId': 'NCT01377168', 'briefTitle': 'Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder', 'orgStudyIdInfo': {'id': 'XR-NTX ETOH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo pill', 'description': 'Daily oral placebo.', 'interventionNames': ['Drug: Placebo pill']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NTX', 'description': 'Daily oral naltrexone.', 'interventionNames': ['Drug: oral naltrexone']}], 'interventions': [{'name': 'oral naltrexone', 'type': 'DRUG', 'otherNames': ['Nalerona'], 'armGroupLabels': ['NTX']}, {'name': 'Placebo pill', 'type': 'DRUG', 'armGroupLabels': ['Placebo pill']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lima', 'country': 'Peru', 'facility': 'Asociación Civil Impacta Salud y Educación', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}], 'overallOfficials': [{'name': 'Ann Duerr, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Center'}, {'name': 'Frederick Altice, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yale University', 'class': 'OTHER'}, {'name': 'Asociación Civil Impacta Salud y Educación, Peru', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Member', 'investigatorFullName': 'Ann C Duerr', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}