protocolSection identificationModule nctId: NCT06303778, orgStudyIdInfo id: IIR 22-141, secondaryIdInfos id: HX003742-01A1, type: OTHER_GRANT, domain: VA HSR&D, briefTitle: Combining a Smartphone App With Medications to Manage Heavy Drinking, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2028-06-01, completionDateStruct date: 2028-06-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally., conditionsModule conditions: Alcohol Use Disorder (AUD), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Following completion of informed consent and baseline assessments, participants will be randomized in a 1:1 ratio to MAUD+SD-App or MAUD only conditions., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: Stand Down mobile app, interventions name: Standard Care, outcomesModule primaryOutcomes measure: Change in Percent Heavy Drinking Days, primaryOutcomes measure: Semi-structured qualitative interview data from patients, providers, clinical leaders, secondaryOutcomes measure: Change in Short Inventory of Problems - Revised version (SIP-R), secondaryOutcomes measure: Change in World Health Organization (WHO) Risk Levels, secondaryOutcomes measure: Change in Client Satisfaction Questionnaire (CSQ) Scores, secondaryOutcomes measure: Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores, secondaryOutcomes measure: Change in PTSD Checklist for DSM-5 (PCL-5) Scores, secondaryOutcomes measure: Change in Veterans RAND 12 Item Health Survey Scores, secondaryOutcomes measure: Change in Percent Heavy Drinking Days, secondaryOutcomes measure: Change in Short Inventory of Problems - Revised version (SIP-R), secondaryOutcomes measure: Change in World Health Organization (WHO) Risk Levels, secondaryOutcomes measure: Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores, secondaryOutcomes measure: Number of Participants Receiving VA Outpatient Substance Use Disorder Treatment, secondaryOutcomes measure: Number of Participants Receiving VA Emergency Department Services, secondaryOutcomes measure: Change in PTSD Checklist for DSM-5 (PCL-5) Scores, secondaryOutcomes measure: Change in Veterans RAND 12 Item Health Survey Scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central Alabama Veterans Health Care System West Campus, Montgomery, AL, city: Montgomery, state: Alabama, zip: 36109, country: United States, contacts name: Sebastian Skordallos, PharmD, role: CONTACT, email: Sebastian.Skordallos@va.gov, geoPoint lat: 32.36681, lon: -86.29997, locations facility: Phoenix VA Health Care System, Phoenix, AZ, city: Phoenix, state: Arizona, zip: 85012, country: United States, contacts name: Courtney Speaks, PharmD, role: CONTACT, email: Courtney.Speaks@va.gov, geoPoint lat: 33.44838, lon: -112.07404, locations facility: VA Northern California Health Care System, Mather, CA, city: Sacramento, state: California, zip: 95655-4200, country: United States, contacts name: Christine Johnston, PharmD, role: CONTACT, email: Christine.Johnston2@va.gov, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Carl Vinson VA Medical Center, Dublin, GA, city: Dublin, state: Georgia, zip: 31021, country: United States, contacts name: Deborah Hobbs, PharmD, role: CONTACT, email: Deborah.Hobbs@va.gov, geoPoint lat: 32.54044, lon: -82.90375, locations facility: Battle Creek VA Medical Center, Battle Creek, MI, city: Battle Creek, state: Michigan, zip: 49037, country: United States, contacts name: Elizabeth Ratti, PharmD, role: CONTACT, email: Elizabeth.Ratti@va.gov, geoPoint lat: 42.3173, lon: -85.17816, locations facility: Minneapolis VA Health Care System, Minneapolis, MN, city: Minneapolis, state: Minnesota, zip: 55417-2309, country: United States, contacts name: Elizabeth Welch, PharmD, role: CONTACT, phone: 612-618-8725, email: Elizabeth.Welch@va.gov, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Kansas City VA Medical Center, Kansas City, MO, city: Kansas City, state: Missouri, zip: 64128-2226, country: United States, contacts name: Kyleigh Gould, PharmD, role: CONTACT, email: Kyleigh.Gould@va.gov, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, city: Nashville, state: Tennessee, zip: 37212-2637, country: United States, contacts name: Matthew Phillips, PharmD, role: CONTACT, email: Matthew.Phillips1@va.gov, geoPoint lat: 36.16589, lon: -86.78444, locations facility: South Texas Health Care System, San Antonio, TX, city: San Antonio, state: Texas, zip: 78229-4404, country: United States, contacts name: Cynthia Mascarenas, PharmD, role: CONTACT, email: Cynthia.Mascarenas@va.gov, geoPoint lat: 29.42412, lon: -98.49363, locations facility: VA Salt Lake City Health Care System, Salt Lake City, UT, city: Salt Lake City, state: Utah, zip: 84148-0001, country: United States, contacts name: Chad Nelson, PharmD, role: CONTACT, email: Chad.Nelson@va.gov, geoPoint lat: 40.76078, lon: -111.89105, locations facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA, city: Seattle, state: Washington, zip: 98108-1532, country: United States, contacts name: Thomas S Bundt, FACHE, role: CONTACT, phone: 253-583-3500, email: thomas.bundt@va.gov, contacts name: Susan Perez, BA, role: CONTACT, phone: (202) 461-6910, email: susan.perez@va.gov, contacts name: Eric J. Hawkins, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False