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Combining a Smartphone App With Medications to Manage Heavy Drinking

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 2 changed
See other at-risk trials from VA Office of Research and Development

Record History

  1. Primary endpoint(s) modified Eligibility criteria expanded, about 26 words · Secondary endpoints revised (14) · Study description revised · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints revised (14)
    • Study description revised
    • Site details revised at 1 of 15 sites
  2. Study sites: 11 to 15 Study description shortened, about 2 wordsv6 Show 1 more changeShow less
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Study sites revised (11)v5 Show 1 more changeShow less
    • Study sites revised (11)

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Oct 1, 2024 to Nov 1, 2024 Primary and study completion dates: Oct 1, 2028 to Nov 1, 2028v4 Show 1 more changeShow less
    • Primary and study completion dates: Oct 1, 2028 to Nov 1, 2028
  5. Start date: Sep 1, 2024 to Oct 1, 2024 Primary and study completion dates: Sep 1, 2028 to Oct 1, 2028v3 Show 1 more changeShow less
    • Primary and study completion dates: Sep 1, 2028 to Oct 1, 2028
  6. Start date: Jun 1, 2024 to Sep 1, 2024 Primary and study completion dates: Jun 1, 2028 to Sep 1, 2028 · Site contacts updated at 1 of 11 sitesv2 Show 2 more changesShow less
    • Primary and study completion dates: Jun 1, 2028 to Sep 1, 2028
    • Site contacts updated at 1 of 11 sites
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06303778
Lead Sponsor VA Office of Research and Development
Conditions Alcohol Use Disorder (AUD)
Enrollment 330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov