Combining a Smartphone App With Medications to Manage Heavy Drinking
NCT ID: NCT06303778
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
330 participants
INTERVENTIONAL
2024-11-01
2028-11-01
Brief Summary
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Detailed Description
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Significance: This study has the potential to substantially improve Veterans' receipt of guideline-concordant AUD care and support national VA initiatives to increase access to AUD care in general healthcare clinics.
Innovation \& Impact: To the investigators' knowledge, no prior study has evaluated the effectiveness of an alcohol-related intervention, delivered by smartphone, with MAUD in primary care. Smartphone apps can be scaled up at relatively low cost, potentially saving lives and improving the quality of care of tens of thousands of Veterans.
Specific Aims: The two aims are to: 1) determine whether MAUD plus SD-App offered to primary care patients diagnosed with AUD, compared to MAUD only, results in (a) greater reductions in heavy drinking days, from baseline to 6-months (primary), (b) greater improvements in alcohol consequences, alcohol use risk levels, and mental health outcomes, from baseline to 6-months (secondary), 2) conduct a process evaluation to identify factors that influence the adoption, implementation, and sustainability of SD-App in combination with MAUD in VA primary care from Veterans', clinical pharmacist specialists' and clinical leaders' perspectives. The investigators will also explore whether MAUD plus SD-App increases MAUD 6-month adherence relative to SD-App alone.
Methodology: Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, this Hybrid 1 effectiveness-implementation trial will enroll 330 Veterans across 15 VA sites. Veterans between ages 18-80, meeting AUD criteria, and planning to initiate MAUD will be randomized to MAUD+SD-App or MAUD only. Participants randomized to MAUD+SD-App will receive access to SD-App. MAUD will be prescribed by VA clinical prescribers per standard care. The primary and secondary outcomes will be assessed at baseline, 3-, 6- and 12-months using participant self-report and electronic medical record data. The investigators will complete qualitative interviews to assess Veterans', clinical pharmacists', and clinical leaders' perspectives on barriers and facilitators to adoption, implementation, and sustainability of SD-App in combination with MAUD in primary care.
Next Steps/Implementation: If MAUD+SD-App improves drinking outcomes, the investigators will work closely with the operations partners to review study findings and to develop a tailored implementation strategy to support widespread implementation across VA primary care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standard Care
Participants assigned to the standard care condition will receive standard MAUD care delivered by their CPSs and will not receive access to SD-App. Three medications, naltrexone, disulfiram, and acamprosate, have been approved by the Federal Drug Administration and topiramate has been recommended by the VA/DoD clinical practice guidelines for SUD. MAUD includes these four medications. All medication decisions will be between the CPS and the Veteran and not influenced by study participation.
Standard Care
Participants assigned to the standard care condition will receive standard MAUD care delivered by their CPSs and will not receive access to SD-App. Three medications, naltrexone, disulfiram, and acamprosate, have been approved by the Federal Drug Administration and topiramate has been recommended by the VA/DoD clinical practice guidelines for SUD. MAUD includes these four medications. All medication decisions will be between the CPS and the Veteran and not influenced by study participation.
Combined MAUD+SD-App
In addition to standard MAUD care, participants assigned to the MAUD+SD-App condition will receive access to the Stand Down app at randomization.
Stand Down mobile app
The Stand Down mobile app is a smartphone-based stand-alone intervention designed to help persons manage drinking and alcohol-related problems on their own. The app is based on principles of motivational enhancement and cognitive-behavioral therapies and comprises 7 modules organized around 4 goals: (i) Enhance awareness of drinking patterns (assessment and personalized feedback), (ii) Establish and monitor progress towards drinking goal - i.e., moderation or abstinence, (iii) Manage cravings and other problems using in-the-moment tools, and (iv) Connect users with other types of support.
Interventions
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Stand Down mobile app
The Stand Down mobile app is a smartphone-based stand-alone intervention designed to help persons manage drinking and alcohol-related problems on their own. The app is based on principles of motivational enhancement and cognitive-behavioral therapies and comprises 7 modules organized around 4 goals: (i) Enhance awareness of drinking patterns (assessment and personalized feedback), (ii) Establish and monitor progress towards drinking goal - i.e., moderation or abstinence, (iii) Manage cravings and other problems using in-the-moment tools, and (iv) Connect users with other types of support.
Standard Care
Participants assigned to the standard care condition will receive standard MAUD care delivered by their CPSs and will not receive access to SD-App. Three medications, naltrexone, disulfiram, and acamprosate, have been approved by the Federal Drug Administration and topiramate has been recommended by the VA/DoD clinical practice guidelines for SUD. MAUD includes these four medications. All medication decisions will be between the CPS and the Veteran and not influenced by study participation.
Eligibility Criteria
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Inclusion Criteria
* 1\) diagnosed with an AUD and report 4 HDD
* (defined as 5 standard drinks per day for men and 4 standard drinks per day for women) in prior 30-days
* 2\) enrolled in VA primary care
* 3\) planning to initiate MAUD, as determined by a medication order
* 4\) between ages 18-80
* 5\) willing to be randomized
* 6\) Android or iPhone smartphone owners
Exclusion Criteria
* 2\) prior episode of MAUD receipt in the last 30 days (initiation of a new episode of MAUD in the 7 days prior to screening allowed)
* 3\) plans to be or are pregnant
* 4\) severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol, as determined by the referring provider. Veterans aged \>80 were excluded because ownership and use of mHealth apps decreases with advancing age. Participants who enter SUD specialty care following randomization will be allowed to continue in the study
18 Years
80 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Eric J. Hawkins, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Locations
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Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States
Veterans Health Care System of the Ozarks, Fayetteville, AR
Fayetteville, Arkansas, United States
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States
Carl Vinson VA Medical Center, Dublin, GA
Dublin, Georgia, United States
Battle Creek VA Medical Center, Battle Creek, MI
Battle Creek, Michigan, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States
Richmond VA Medical Center, Richmond, VA
Richmond, Virginia, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HX003742-01A1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IIR 22-141
Identifier Type: -
Identifier Source: org_study_id
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