RECRUITING

Combining a Smartphone App With Medications to Manage Heavy Drinking

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Combining a Smartphone App With Medications to Manage Heavy Drinking

Quick Facts

Study Start:2024-11-01
Study Completion:2028-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06303778

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1) diagnosed with an AUD and report 4 HDD
  2. * (defined as 5 standard drinks per day for men and 4 standard drinks per day for women) in prior 30-days
  3. * 2) enrolled in VA primary care
  4. * 3) planning to initiate MAUD, as determined by a medication order
  5. * 4) between ages 18-80
  6. * 5) willing to be randomized
  7. * 6) Android or iPhone smartphone owners
  1. * 1) past 30-day participation in VA or non-VA SUD treatment
  2. * 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. * 3) plans to be or are pregnant
  4. * 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

Contacts and Locations

Study Contact

Eric J Hawkins, PhD
CONTACT
(206) 764-2743
eric.hawkins@va.gov
Anissa N Danner, MSW BA
CONTACT
(206) 277-4878
anissa.danner@va.gov

Principal Investigator

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

Study Locations (Sites)

Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
United States
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, Arkansas, 77205
United States
Washington DC VA Medical Center, Washington, DC
Washington, District of Columbia, 20422-0001
United States
Carl Vinson VA Medical Center, Dublin, GA
Dublin, Georgia, 31021
United States
Battle Creek VA Medical Center, Battle Creek, MI
Battle Creek, Michigan, 49037
United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
United States
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, 64128-2226
United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01
Study Completion Date2028-11-01

Study Record Updates

Study Start Date2024-11-01
Study Completion Date2028-11-01

Terms related to this study

Keywords Provided by Researchers

  • alcohol use disorder
  • substance use disorder
  • medications for AUD
  • smartphone app
  • primary care
  • mobile health

Additional Relevant MeSH Terms

  • Alcohol Use Disorder (AUD)