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Smartphone App and Medications for Heavy Drinking in Veterans

This study is for Veterans aged 18-80 who have Alcohol Use Disorder (AUD), meaning they drink heavily. It aims to see if combining a smartphone app called "Stand Down" with standard AUD medications (like naltrexone, disulfiram, acamprosate, or topiramate) helps Veterans manage their drinking better. You would either use the Stand Down app along with your medications or receive standard medication care without the app. The researchers will measure how much your heavy drinking days change over 6 months. This study is currently unclear about its recruitment status and plans to enroll 330 participants.

Study design
This is an interventional study that will involve about 330 participants. Participants will be randomly assigned to either use the Stand Down app with their medication or receive standard medication care.
What's involved
The study will track changes in heavy drinking days over 6 months. Some participants will also have semi-structured interviews at 3 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after starting the study to measure changes in heavy drinking days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06303778

Combining a Smartphone App With Medications to Manage Heavy Drinking

Recruiting
NAAges 18–80InterventionalHealth services
VA Office of Research and Development
~330 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:Stand Down mobile appStandard Care

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Percent Heavy Drinking Days
Measured over 6 months post-baseline
+1 more outcome measured

Conditions

Alcohol Use Disorder (AUD)

Explore related trials

Alcohol use disorder

Where it's being run

15 sites across 13 states
Georgia2
Texas2
Arizona1
Arkansas1
District of Columbia1
Florida1
Michigan1
Minnesota1

Study leadership

  • Eric J. Hawkins, PhD · PRINCIPAL_INVESTIGATOR · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Who to contact

Eric J Hawkins, PhD
[email protected]
(206) 764-2743
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Percent Heavy Drinking Days6 months post-baseline

    Change from baseline to 6-month follow-up in percent heavy drinking days (HDD), defined as \>4 drinks per day for women and \>5 drinks per day for men, was selected as the primary outcome as it combines both frequency and intensity of drinking and is a clinically meaningful measure of change. HDD will be generated from the Timeline Follow Back (TLFB), a retrospective, calendar-based measure that provides information on quantity/frequency of alcohol use in the past 30 days. Percent HDD will be calculated by dividing the number of HDD during a one-month period by 30 days.

  • Semi-structured qualitative interview data from patients, providers, clinical leaders3 months post-baseline

    \[Qualitative\] Patient, provider, and clinical leader perspectives regarding barriers and facilitators to adoption, implementation, and sustainability of the Stand Down mobile application in combination with medications for AUD in primary care.