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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.

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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

FieldValue
Enrollment Target 330 participants
Start Date 2024-11-01
Est. Completion 2028-11-01
Phase NA
VA Office of Research and Development

1,668 total trials

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.

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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Source: ClinicalTrials.gov NCT06303778, the US trial registry maintained by the National Library of Medicine. NCT06303778 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.