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NCT06303778 · ClinicalTrials.gov registry record · NA
Combining a Smartphone App With Medications to Manage Heavy Drinking
A NA study of Alcohol Use Disorder (AUD), sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 330
- Enrollment target
- 15
- Study locations
NCT06303778: Recruiting NA study of Alcohol Use Disorder (AUD), sponsored by VA Office of Research and Development.
NCT06303778 is a NA study of Alcohol Use Disorder (AUD) that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 330 participants, below the 1,813-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (82% lower). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06303778, a NA study of Alcohol Use Disorder (AUD), is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 330 participants
- Enrollment target
- 15
- Study locations
Study 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.
Primary Outcome
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 ca
Conditions Studied
Interventions
- OTHER Standard Care
- OTHER Stand Down mobile app
Study Locations (15)
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
- Carl Vinson VA Medical Center, Dublin, GA - Dublin
Texas
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX - Dallas
- South Texas Health Care System, San Antonio, TX - San Antonio
Arizona
- Phoenix VA Health Care System, Phoenix, AZ - Phoenix
Arkansas
- Veterans Health Care System of the Ozarks, Fayetteville, AR - Fayetteville
District of Columbia
- Washington DC VA Medical Center, Washington, DC - Washington D.C.
Florida
- North Florida/South Georgia Veterans Health System, Gainesville, FL - Gainesville
Michigan
- Battle Creek VA Medical Center, Battle Creek, MI - Battle Creek
Minnesota
- Minneapolis VA Health Care System, Minneapolis, MN - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2024-11-01 |
| Est. Completion | 2028-11-01 |
| Phase | NA |
What NCT06303778 shows while recruiting
NCT06303778 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 1,813-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Alcohol Use Disorder (AUD) appearing as the primary indexed condition, and to 2 interventions - of which Standard Care is the first listed.
NCT06303778 lists 15 locations in 13 states (Georgia, Texas, Arizona).
Frequently Asked Questions
What is clinical trial NCT06303778 about?
NCT06303778 is a clinical study titled "Combining a Smartphone App With Medications to Manage Heavy Drinking". 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 Vet...
What is the current status of trial NCT06303778?
This trial is currently recruiting. It is a NA study. The enrollment target is 330 participants. The study started on 2024-11-01. Estimated completion is 2028-11-01.
What conditions does trial NCT06303778 study?
This clinical trial studies the following conditions: Alcohol Use Disorder (AUD).
What interventions are being tested in trial NCT06303778?
The interventions under investigation include: Standard Care (OTHER), Stand Down mobile app (OTHER).
Who is sponsoring clinical trial NCT06303778?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06303778 being conducted?
This trial has 15 study locations across Arizona, Arkansas, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder (AUD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06303778's enrollment target sits among peer trials
330 3rd of 30 higher than 28 of 30 other Alcohol Use Disorder (AUD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder (AUD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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