Combining a Smartphone App With Medications to Manage Heavy Drinking
2 other identifiers
interventional
330
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
October 31, 2025
October 1, 2025
4 years
February 9, 2024
October 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Percent Heavy Drinking Days
Change from baseline to 6-month follow-up in percent heavy drinking days (HDD), defined as \>4 drinks per day for women and \>5 drinks per day for men, was selected as the primary outcome as it combines both frequency and intensity of drinking and is a clinically meaningful measure of change. HDD will be generated from the Timeline Follow Back (TLFB), a retrospective, calendar-based measure that provides information on quantity/frequency of alcohol use in the past 30 days. Percent HDD will be calculated by dividing the number of HDD during a one-month period by 30 days.
6 months post-baseline
Semi-structured qualitative interview data from patients, providers, clinical leaders
\[Qualitative\] Patient, provider, and clinical leader perspectives regarding barriers and facilitators to adoption, implementation, and sustainability of the Stand Down mobile application in combination with medications for AUD in primary care.
3 months post-baseline
Secondary Outcomes (14)
Change in Short Inventory of Problems - Revised version (SIP-R)
6 months post-baseline
Change in World Health Organization (WHO) Risk Levels
6 months post-baseline
Change in Client Satisfaction Questionnaire (CSQ) Scores
6 months post-baseline
Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores
6 months post-baseline
Change in PTSD Checklist for DSM-5 (PCL-5) Scores
6 months post-baseline
- +9 more secondary outcomes
Study Arms (2)
Standard Care
ACTIVE COMPARATORParticipants 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
EXPERIMENTALIn addition to standard MAUD care, participants assigned to the MAUD+SD-App condition will receive access to the Stand Down app at randomization.
Interventions
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.
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
You may qualify if:
- To be eligible, Veterans must be:
- \) 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
- \) enrolled in VA primary care
- \) planning to initiate MAUD, as determined by a medication order
- \) between ages 18-80
- \) willing to be randomized
- \) Android or iPhone smartphone owners
You may not qualify if:
- \) past 30-day participation in VA or non-VA SUD treatment
- \) 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)
- \) plans to be or are pregnant
- \) 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012, United States
Veterans Health Care System of the Ozarks, Fayetteville, AR
Fayetteville, Arkansas, 72703-1944, United States
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422-0001, United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135, United States
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004, United States
Carl Vinson VA Medical Center, Dublin, GA
Dublin, Georgia, 31021, United States
Battle Creek VA Medical Center, Battle Creek, MI
Battle Creek, Michigan, 49037, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309, United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637, United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167, United States
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229-4404, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001, United States
Richmond VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric J. Hawkins, PhD
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2024
First Posted
March 12, 2024
Study Start
November 1, 2024
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
October 31, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share