Using a smartphone app with medications to help Veterans manage heavy drinking
Combining a Smartphone App With Medications to Manage Heavy Drinking
NA · VA Office of Research and Development · NCT06303778
This study is testing if using a smartphone app along with medication can help Veterans with heavy drinking manage their alcohol use better than just medication alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 15 sites (Phoenix, Arizona and 14 other locations) |
| Trial ID | NCT06303778 on ClinicalTrials.gov |
What this trial studies
This study aims to improve treatment for Veterans with alcohol use disorder (AUD) by combining a smartphone app, called Stand Down, with standard medication-assisted treatment (MAUD). The app is designed to help Veterans self-manage their alcohol use through personalized strategies and self-monitoring features. By offering both the app and medications in primary care settings, the study seeks to address barriers such as stigma and access to care that often prevent Veterans from receiving comprehensive treatment. The effectiveness of this combined approach will be evaluated by comparing drinking outcomes between Veterans using both the app and medications versus those receiving medications alone.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans aged 18-80 diagnosed with alcohol use disorder who are enrolled in VA primary care and own a smartphone.
Not a fit: Patients who have recently participated in substance use disorder treatment or have severe psychiatric symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve drinking outcomes for Veterans with alcohol use disorder by providing accessible and effective treatment options.
How similar studies have performed: Previous studies have shown promise in using smartphone apps for alcohol interventions, indicating potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Phoenix, Arizona and 14 other locations
- Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States (RECRUITING)
- Veterans Health Care System of the Ozarks, Fayetteville, AR — Fayetteville, Arkansas, United States (RECRUITING)
- Washington DC VA Medical Center, Washington, DC — Washington D.C., District of Columbia, United States (RECRUITING)
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States (RECRUITING)
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (RECRUITING)
- Carl Vinson VA Medical Center, Dublin, GA — Dublin, Georgia, United States (RECRUITING)
- Battle Creek VA Medical Center, Battle Creek, MI — Battle Creek, Michigan, United States (RECRUITING)
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (RECRUITING)
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska, United States (RECRUITING)
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee, United States (RECRUITING)
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States (RECRUITING)
- South Texas Health Care System, San Antonio, TX — San Antonio, Texas, United States (RECRUITING)
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (RECRUITING)
- Richmond VA Medical Center, Richmond, VA — Richmond, Virginia, United States (RECRUITING)
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Eric J. Hawkins, PhD — VA Puget Sound Health Care System Seattle Division, Seattle, WA
- Study coordinator: Eric J Hawkins, PhD
- Email: eric.hawkins@va.gov
- Phone: (206) 764-2743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcohol Use Disorder, alcohol use disorder, substance use disorder, medications for AUD, smartphone app, primary care, mobile health