Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 12:13 AM
Study NCT ID:
NCT05747703
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth Treatment for 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'participants will be randomly assigned in a 1:1 to the Ria Treatment Platform or a waitlist control condition'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percent of subjects without heavy drinking', 'timeFrame': 'last four weeks', 'description': 'percent of subjects without heavy drinking per timeline follow-back'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder', 'Alcohol Dependence', 'Alcoholism']}, 'descriptionModule': {'briefSummary': 'Participants with alcohol use disorder will be randomly assigned to either the Ria Treatment Platform or a waitlist control. The Ria Treatment Platform is a telehealth approach that incorporates medical assessment, medications for alcohol use disorder, individual and group coaching, educational video modules, and a Bluetooth-enabled breathalyzer. Patients are followed for three months during which data are collected, including measures of alcohol consumption and its consequences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* alcohol use disorder\n\nExclusion Criteria:\n\n* inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05747703', 'briefTitle': 'Telehealth Treatment for Alcohol Use Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ria Health'}, 'officialTitle': 'A Telehealth Intervention to Increase Screening and Treatment for Alcohol Use Disorder', 'orgStudyIdInfo': {'id': '1A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ria Treatment Platfrom', 'description': 'The Ria Treatment Platform is a telehealth approach that includes medical assessment, prescription of clinically appropriate medications for alcohol use disorder, individual and group coaching, educational video modules, and monitoring of breath alcohol concentrations through a Bluetooth-enabled breathalyzer.', 'interventionNames': ['Combination Product: Ria Treatment Platform']}, {'type': 'NO_INTERVENTION', 'label': 'waitlist control', 'description': 'Patients in this arm will not be provided treatment during the study period.'}], 'interventions': [{'name': 'Ria Treatment Platform', 'type': 'COMBINATION_PRODUCT', 'description': 'combined medication, coaching, education, and monitoring', 'armGroupLabels': ['Ria Treatment Platfrom']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Chieng, BA', 'role': 'CONTACT'}, {'name': 'Judith Prochaska, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'LaTrice Montgomery, Ph.D.', 'role': 'CONTACT', 'email': 'latrice.montgomery@riahealth.com', 'phone': '513-349-1052'}, {'name': 'John Mendelson, MD', 'role': 'CONTACT', 'email': 'john.mendelson@riahealth.com'}], 'overallOfficials': [{'name': 'John Mendelson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ria Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ria Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}