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RECRUITING
NCT06303778
NA

Combining a Smartphone App With Medications to Manage Heavy Drinking

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2024-11-01

Completion Date

2028-11-01

Last Updated

2025-10-31

Healthy Volunteers

No

Interventions

OTHER

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.

OTHER

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.

Locations (15)

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