Combining a Smartphone App With Medications to Manage Heavy Drinking
Recruiting now · Not applicable
Conditions studied: Alcohol Use Disorder (AUD)
In brief
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.
Key facts
- Study ID
- NCT06303778
- Run by
- VA Office of Research and Development
- People needed
- 330
- Starts
- 2024-11-01
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2025-10-31
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- To be eligible, Veterans must be:
- 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
You may not qualify if…
- 1) past 30-day participation in VA or non-VA SUD treatment
- 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
Where it is running
- Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States (enrolling)
- Veterans Health Care System of the Ozarks, Fayetteville, AR — Fayetteville, Arkansas, United States (enrolling)
- Washington DC VA Medical Center, Washington, DC — Washington D.C., District of Columbia, United States (enrolling)
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States (enrolling)
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (enrolling)
- Carl Vinson VA Medical Center, Dublin, GA — Dublin, Georgia, United States (enrolling)
- Battle Creek VA Medical Center, Battle Creek, MI — Battle Creek, Michigan, United States (enrolling)
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (enrolling)
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska, United States (enrolling)
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee, United States (enrolling)
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States (enrolling)
- South Texas Health Care System, San Antonio, TX — San Antonio, Texas, United States (enrolling)
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (enrolling)
- Richmond VA Medical Center, Richmond, VA — Richmond, Virginia, United States (enrolling)
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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