Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT05410561
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2022-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2022-05-24', 'studyFirstSubmitQcDate': '2022-06-06', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol Use Disorder Treatment Initiation', 'timeFrame': '3 months', 'description': 'Percent of patients who initiate Alcohol Use Disorder psychotherapy treatment'}, {'measure': 'Alcohol Use Disorder Treatment Engagement', 'timeFrame': '3 months', 'description': 'Percent of patients who attend at least 2 additional Alcohol Use Disorder psychotherapy sessions'}, {'measure': 'Alcohol consumption days', 'timeFrame': '3-months', 'description': 'Percent days of alcohol use on the Timeline Follow Back interview'}, {'measure': 'Alcohol consumption days', 'timeFrame': '6-months', 'description': 'Percent days of alcohol use on the Timeline Follow Back interview'}, {'measure': 'Alcohol consumption days', 'timeFrame': '12-months', 'description': 'Percent days of alcohol use on the Timeline Follow Back interview'}, {'measure': 'Heavy drinking days', 'timeFrame': '3-months', 'description': 'Percent days heavy drinking on the Timeline Follow Back interview'}, {'measure': 'Heavy drinking days', 'timeFrame': '6-months', 'description': 'Percent days heavy drinking on the Timeline Follow Back interview'}, {'measure': 'Heavy drinking days', 'timeFrame': '12-months', 'description': 'Percent days heavy drinking on the Timeline Follow Back interview'}], 'secondaryOutcomes': [{'measure': 'Total Alcohol Use Disorder Psychotherapy Treatment Attendance', 'timeFrame': '6-months', 'description': 'Total number of psychotherapy sessions'}, {'measure': 'Total Alcohol Use Disorder Psychotherapy Treatment Attendance', 'timeFrame': '12-months', 'description': 'Total number of psychotherapy sessions'}, {'measure': 'Drinking Risk Levels (Based on World Health Organization Cut-Offs)', 'timeFrame': 'Baseline to 3-months', 'description': 'Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)'}, {'measure': 'Drinking Risk Levels (Based on World Health Organization Cut-Offs)', 'timeFrame': 'Baseline to 6-months', 'description': 'Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)'}, {'measure': 'Drinking Risk Levels (Based on World Health Organization Cut-Offs)', 'timeFrame': 'Baseline to 12-months', 'description': 'Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)'}, {'measure': 'World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)', 'timeFrame': 'Baseline to 3-months', 'description': 'Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.'}, {'measure': 'World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)', 'timeFrame': 'Baseline to 6-months', 'description': 'Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.'}, {'measure': 'World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)', 'timeFrame': 'Baseline to 12-months', 'description': 'Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.'}, {'measure': 'Alcohol consequences', 'timeFrame': 'Baseline to 3-months', 'description': 'Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R'}, {'measure': 'Alcohol consequences', 'timeFrame': 'Baseline to 6-months', 'description': 'Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R'}, {'measure': 'Alcohol consequences', 'timeFrame': 'Baseline to 12-months', 'description': 'Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telehealth', 'Cognitive behavioral therapy', 'Psychoeducation', 'Motivational interviewing', 'Alcohol consumption'], 'conditions': ['Substance Use Disorders', 'Substance Use', 'Substance Dependence']}, 'referencesModule': {'references': [{'pmid': '38679140', 'type': 'DERIVED', 'citation': 'Bonar EE, Goldstick JE, Rostker MJ, Dailey SE, Augustiniak AN, Brin C, Manderachia DA, Bourque C, Girard R, Sulkowski L, Lin LA. Testing a new model of telehealth-delivered treatment for primary care patients with alcohol use disorder: A randomized controlled trial protocol. Contemp Clin Trials. 2024 Jul;142:107549. doi: 10.1016/j.cct.2024.107549. Epub 2024 Apr 26.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this trial is to test new programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The program sessions focus on getting to know what's important to the participants, reviewing or setting goals, and using different skills and behaviors to better manage health. The trial will help the study team learn about ways to deliver health information in a way that is useful and interesting.\n\nThis research will take place remotely (e.g., Zoom, Facetime, Phone) and participants will be randomized to the Telehealth (TeleTx) group intervention or the Enhanced Usual Care (EUC) control group. Both groups will be asked to have follow-up visits up to 12 months from the baseline visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current Diagnostic and Statistical Manual (DSM) -5 alcohol use disorder (AUD) based on alcohol symptom checklist\n* An average of 3 or more drinking days per week for the past 30 days\n* Have regular access to a device with video capabilities or a phone to use for study related calls\n\nExclusion Criteria:\n\n* Inability to speak or understand English\n* Conditions that preclude informed consent or understanding of assessment or intervention content\n* Past 90-day AUD psychotherapy treatment,\n* At elevated risk for complicated alcohol withdrawal\n* Past-year drug injection.'}, 'identificationModule': {'nctId': 'NCT05410561', 'briefTitle': 'Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients', 'orgStudyIdInfo': {'id': 'HUM00204315'}, 'secondaryIdInfos': [{'id': '1R01AA029400-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01AA029400-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TeleTx intervention', 'description': 'The evidence-based manualized psychosocial program is via telehealth and uses adaptations of cognitive behavioral therapy and motivational interviewing.', 'interventionNames': ['Behavioral: TeleTx intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Usual Care (EUC)', 'description': 'EUC will include brief psychoeducation about AUD and resources for treatment.', 'interventionNames': ['Behavioral: Enhanced Usual Care (EUC)']}], 'interventions': [{'name': 'Enhanced Usual Care (EUC)', 'type': 'BEHAVIORAL', 'description': 'EUC will comprise one session of brief psychoeducation and referral information to alcohol use disorder (AUD) treatment.', 'armGroupLabels': ['Enhanced Usual Care (EUC)']}, {'name': 'TeleTx intervention', 'type': 'BEHAVIORAL', 'description': 'TeleTx will consist of an initial session and then 8 \\~counseling sessions.', 'armGroupLabels': ['TeleTx intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Health Care | Veterans Affairs', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Allison Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Erin Bonar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychiatry', 'investigatorFullName': 'Allison Lin', 'investigatorAffiliation': 'University of Michigan'}}}}