Using a smartphone app with medications to help Veterans manage heavy drinking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

To be eligible, Veterans must be:

* 1\) diagnosed with an alcohol use disorder (AUD) and report 4 heavy drinking days (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 medications for alcohol use disorder (MAUD), as determined by a medication order
* 4\) willing to be randomized
* 5\) Android or iPhone smartphone owners

Exclusion Criteria:

* 1\) past 30-day participation in VA or non-VA substance use disorder (SUD) treatment
* 2\) prior episode of medications for alcohol use disorder 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 substance use disorder specialty care following randomization will be allowed to continue in the study.

Where it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.