Recruiting

Smartphone App with MedicationsCombining a Smartphone App With Medications to Manage Heavy Drinking

Sponsor:

VA Office of Research and Development

Code:

NCT06303778

Conditions

Alcohol Use Disorder (AUD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Stand Down mobile app

Standard Care

Study Details

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.

Conditions

Alcohol Use Disorder (AUD)

Study ID

NCT06303778

Start date

Nov 1, 2024

Status verified date

Oct, 2025

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

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

Primary outcome measure

Change in Percent Heavy Drinking Days [ Time Frame: 6 months post-baseline ]
Semi-structured qualitative interview data from patients, providers, clinical leaders [ Time Frame: 3 months post-baseline ]

Central Contacts and Locations

Central contacts

Eric J Hawkins, PhD

(206) 764-2743 eric.hawkins@va.gov

Anissa N Danner, MSW BA

(206) 277-4878 anissa.danner@va.gov

Locations

Phoenix VA Health Care System, Phoenix, AZ

Recruiting

Phoenix, Arizona, United States, 85012

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

Veterans Health Care System of the Ozarks, Fayetteville, AR

Recruiting

Fayetteville, Arkansas, United States, 72703-1944

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

Washington DC VA Medical Center, Washington, DC

Recruiting

Washington D.C., District of Columbia, United States, 20422-0001

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

North Florida/South Georgia Veterans Health System, Gainesville, FL

Recruiting

Gainesville, Florida, United States, 32608-1135

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

Carl Vinson VA Medical Center, Dublin, GA

Recruiting

Dublin, Georgia, United States, 31021

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

Battle Creek VA Medical Center, Battle Creek, MI

Recruiting

Battle Creek, Michigan, United States, 49037

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Anissa N Danner, MSW BA

(206) 277-4878 anissa.danner@va.gov

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Recruiting

Omaha, Nebraska, United States, 68105-1850

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Recruiting

Nashville, Tennessee, United States, 37212-2637

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Recruiting

Dallas, Texas, United States, 75216-7167

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

South Texas Health Care System, San Antonio, TX

Recruiting

San Antonio, Texas, United States, 78229-4404

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

VA Salt Lake City Health Care System, Salt Lake City, UT

Recruiting

Salt Lake City, Utah, United States, 84148-0001

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

Richmond VA Medical Center, Richmond, VA

Recruiting

Richmond, Virginia, United States, 23249-0001

Contacts

Anissa Danner, MSW

Anissa.Danner@va.gov

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Recruiting

Seattle, Washington, United States, 98108-1532

Contacts

Thomas S Bundt, FACHE

(253) 583-3500 thomas.bundt@va.gov

Susan Perez, BA

(202) 461-6910 susan.perez@va.gov

Principal Investigator:

Eric J. Hawkins, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

alcohol use disorder
substance use disorder
medications for AUD
smartphone app
primary care
mobile health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-10-31.