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Search / Trial NCT06303778

Combining a Smartphone App With Medications to Manage Heavy Drinking

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Mar 4, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Alcohol Use Disorder Substance Use Disorder Medications For Aud Smartphone App Primary Care Mobile Health

ClinConnect Summary

This clinical trial is studying the effectiveness of using a smartphone app along with medications to help Veterans manage heavy drinking, specifically those diagnosed with Alcohol Use Disorder (AUD). Many Veterans struggle to access effective treatments for AUD due to long wait times, stigma, and distance from facilities. This study aims to see if combining medication with a smartphone app can lead to better drinking outcomes compared to just taking medication alone.

To be eligible for the trial, participants need to be Veterans aged 18 to 80 who have been diagnosed with AUD and have reported heavy drinking in the past month. They must also be enrolled in VA primary care and willing to be randomly assigned to one of the study groups. Participants will receive either the app and medications or just the medications, and the goal is to understand how effective this combination can be in helping them reduce their alcohol use. This research could help improve access to treatment for Veterans across the country.

Gender

ALL

Eligibility 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

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Phoenix, Arizona, United States

Nashville, Tennessee, United States

Battle Creek, Michigan, United States

Montgomery, Alabama, United States

Dublin, Georgia, United States

Kansas City, Missouri, United States

Minneapolis, Minnesota, United States

Dallas, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Washington, District Of Columbia, United States

Seattle, Washington, United States

Sacramento, California, United States

Omaha, Nebraska, United States

Little Rock, Arkansas, United States

Patients applied

0 patients applied

Trial Officials

Eric J. Hawkins, PhD

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported