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Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized Controlled Trial for Alcohol Use Disorder (CRAVE)

Study acronym: CRAVE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Apr 28, 2028 → Mar 31, 2029
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from VA Office of Research and Development

Record History

  1. Eligibility criteria expanded, about 48 words Secondary endpoints revised (4) · Study description expanded, about 15 words · Site details revised at 1 of 19 sites Show 3 more changesShow less
    • Secondary endpoints revised (4)
    • Study description expanded, about 15 words
    • Site details revised at 1 of 19 sites
  2. Eligibility criteria expanded, about 27 words Study description revised · Site details revised at 8 of 19 sitesv8 Show 2 more changesShow less
    • Study description revised
    • Site details revised at 8 of 19 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 5 of 19 sitesv7
  4. Eligibility criteria expanded, about 17 words Secondary endpoints: 12 to 4 · Study description expanded, about 369 words · Study sites revised (19) · 1 morev6 Show 4 more changesShow less
    • Secondary endpoints: 12 to 4
    • Study description expanded, about 369 words
    • Study sites revised (19)
    • Study title shortened, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion pushed from Apr 28, 2028 to Mar 31, 2029 Recruitment opened · Completion pushed from May 26, 2029 to Mar 30, 2030 · Secondary endpoints: details revised at 1 of 12 entries · 3 morev5 Show 6 more changesShow less
    • Recruitment opened
    • Completion pushed from May 26, 2029 to Mar 30, 2030
    • Secondary endpoints: details revised at 1 of 12 entries
    • Study description revised
    • Study sites revised (19)
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Primary endpoint(s) modified Trial sites expanded: 1 → 19 locations · Start date: Jul 1, 2026 to Jul 28, 2026 · Eligibility criteria expanded, about 12 words · 1 morev4 Show 4 more changesShow less
    • Trial sites expanded: 1 → 19 locations
    • Start date: Jul 1, 2026 to Jul 28, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints revised (12)

    See this version in full on ClinicalTrials.gov ↗

  7. Start date: May 1, 2026 to Jul 1, 2026 Enrollment increased: 438 → 622 participantsv3 Show 1 more changeShow less
    • Enrollment increased: 438 → 622 participants
  8. Start date: Jan 1, 2026 to May 1, 2026 Primary completion date: Dec 31, 2028 to Apr 28, 2028 · Completion date: Jan 26, 2029 to May 26, 2029 · Site contact updatedv2 Show 3 more changesShow less
    • Primary completion date: Dec 31, 2028 to Apr 28, 2028
    • Completion date: Jan 26, 2029 to May 26, 2029
    • Site contact updated
  9. 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.
This clinical trial aims to test the effectiveness and safety of semaglutide, a GLP-1 receptor agonist, in treating moderate to severe alcohol use disorder (AUD) in Veterans. Participants who qualify will be randomly assigned to receive either semaglutide injections or placebo injections over a 24-week period, followed by a 4-week post-treatment safety assessment period. Participants receiving semaglutide will start with a low dose, gradually increasing to a maximum of 2.4 milligrams (mg) per week, depending on their tolerance. The primary measure of success will be a reduction in risky drinking, assessed through a reliable calendar-based interview method called the Timeline Follow-Back (TLFB), a well-validated calendar-based interview technique for recording daily alcohol consumption. The purpose of this research is to gather information on the safety and effectiveness of semaglutide for treating AUD, potentially offering a new and more appealing treatment option.
Trial Details
NCT Number NCT07218354
Lead Sponsor VA Office of Research and Development
Conditions Alcohol Use Disorder
Enrollment 622 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov