Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06303778

Combining a Smartphone App With Medications to Manage Heavy Drinking in Veterans with Alcohol Use Disorder

Led by VA Office of Research and Development · Updated on 2025-10-31

330

Participants Needed

15

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether combining medications for alcohol use disorder (MAUD) with a smartphone app called Stand Down (SD-App) can improve drinking outcomes for Veterans diagnosed with alcohol use disorder (AUD) compared to medications alone. This study addresses barriers Veterans face in accessing psychosocial treatments, such as stigma and distance from clinics, by offering an app-based intervention alongside medication in primary care settings. The trial aims to inform how to spread this app across VA facilities nationally. Participants will be randomly assigned to receive either standard MAUD care or MAUD plus access to the Stand Down app. MAUD includes medications like naltrexone, disulfiram, acamprosate, and topiramate, prescribed by VA clinical providers as usual care. The Stand Down app helps users manage alcohol use through personalized strategies, self-monitoring, and support tools, delivered via their smartphones. The study will enroll 330 Veterans across 15 VA sites and follow them for up to 12 months. Throughout the study, participants will complete assessments at baseline, 3, 6, and 12 months, including self-reports and medical record reviews to measure heavy drinking days, alcohol-related problems, risk levels, mental health symptoms, and treatment adherence. Researchers will also conduct interviews with Veterans and VA staff to explore factors affecting the app's adoption and use. The total study participation may last up to one year with ongoing monitoring of drinking behaviors and health outcomes.

CONDITIONS

Brief Title

Combining a Smartphone App With Medications to Manage Heavy Drinking

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with alcohol use disorder and reported at least 4 heavy drinking days in the past 30 days (5+ drinks for men, 4+ for women)
  • Enrolled in VA primary care
  • Planning to start medications for alcohol use disorder as indicated by a medication order
  • Between 18 and 80 years old
  • Willing to be randomly assigned to a study group
  • Own an Android or iPhone smartphone
Not Eligible

You will not qualify if you...

  • Participation in substance use disorder treatment in the past 30 days
  • Received medications for alcohol use disorder within the past 30 days, except new starts within 7 days before screening
  • Pregnant or planning to become pregnant
  • Severe psychiatric symptoms or psychosocial instability that would prevent study participation, as determined by the provider
  • Over 80 years old due to decreased use of mobile health apps with age

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) to confirm eligibility and consent

Treatment

Duration - Up to 6 months

Participants begin medication for alcohol use disorder (MAUD) as prescribed by their clinical pharmacist specialists. Those randomized to the experimental group also receive access to the Stand Down smartphone app to support managing their drinking.

Baseline visit at treatment start and follow-up visits aligned with routine VA primary care and medication management

Follow-up

Duration - 6 to 12 months post-baseline

Participants are followed for continued evaluation of drinking behavior, mental health, and satisfaction with care up to 12 months post-baseline.

Assessments at 3, 6, and 12 months via self-report and medical record review

Trial Site Locations

Total: 15 locations

1

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, United States, 85012

Actively Recruiting

2

Veterans Health Care System of the Ozarks, Fayetteville, AR

Fayetteville, Arkansas, United States, 72703-1944

Actively Recruiting

3

Washington DC VA Medical Center, Washington, DC

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

Actively Recruiting

4

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

Gainesville, Florida, United States, 32608-1135

Actively Recruiting

5

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States, 30033-4004

Actively Recruiting

6

Carl Vinson VA Medical Center, Dublin, GA

Dublin, Georgia, United States, 31021

Actively Recruiting

7

Battle Creek VA Medical Center, Battle Creek, MI

Battle Creek, Michigan, United States, 49037

Actively Recruiting

8

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States, 55417-2309

Actively Recruiting

9

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

Omaha, Nebraska, United States, 68105-1850

Actively Recruiting

10

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, United States, 37212-2637

Actively Recruiting

11

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

Dallas, Texas, United States, 75216-7167

Actively Recruiting

12

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States, 78229-4404

Actively Recruiting

13

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

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

Actively Recruiting

14

Richmond VA Medical Center, Richmond, VA

Richmond, Virginia, United States, 23249-0001

Actively Recruiting

15

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

Seattle, Washington, United States, 98108-1532

Actively Recruiting

Loading map...

Research Team

E

Eric J Hawkins, PhD

A

Anissa N Danner, MSW BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

Similar Trials

A Randomised Controlled Trial of N-acetylcysteine for the Ma...

Alcohol Use Disorder (AUD)

Actively Recruiting

3 locations

Alcohol and the Social Brain: An Alcohol-Administration Hype...

Alcohol Drinking

Actively Recruiting

2 locations

A Focus on Alpha-1 Blockade as a Novel Pharmacological Treat...

Alcohol Use Disorder (AUD)

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here