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Varenicline for Smoking Reduction in Veterans Not Ready To Quit

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from VA Office of Research and Development

Record History

  1. Recruitment opened Site details revised at 4 of 4 sites · Eligibility criteria shortened, about 3 words · Study description expanded, about 1 wordv9 Show 3 more changesShow less
    • Site details revised at 4 of 4 sites
    • Eligibility criteria shortened, about 3 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv8
  3. Primary endpoint(s) modified Start date: Jul 20, 2026 to Aug 17, 2026 · Secondary endpoints revised (3)v7 Show 2 more changesShow less
    • Start date: Jul 20, 2026 to Aug 17, 2026
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Jul 1, 2026 to Jul 20, 2026v6
  5. Site contacts updated at 1 of 4 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Apr 1, 2026 to Jul 1, 2026 Primary and study completion dates: Mar 31, 2031 to Jun 28, 2030v4 Show 1 more changeShow less
    • Primary and study completion dates: Mar 31, 2031 to Jun 28, 2030
  2. Study description expanded, about 2 wordsv3 See this version in full on ClinicalTrials.gov ↗
  3. Primary and study completion dates: Sep 30, 2030 to Mar 31, 2031 Start date: Dec 1, 2025 to Apr 1, 2026 · Study description shortened, about 2 wordsv2 Show 2 more changesShow less
    • Start date: Dec 1, 2025 to Apr 1, 2026
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In order to reduce the prevalence of cigarette smoking among Veterans, it is vital that healthcare providers offer effective tobacco treatment to all Veterans who smoke, including those not ready to make a quit attempt. Smoking treatments currently available to Veterans who are not ready to quit are only weakly effective. This project will generate new knowledge about the effectiveness of a promising varenicline-based intervention designed to increase quit attempts and long-term abstinence in Veterans who are initially not ready to quit. This project has great potential to engage Veterans not ready to quit smoking in treatment that increases quit attempts and quitting success, thereby reducing morbidity and mortality caused by smoking in Veterans.
Trial Details
NCT Number NCT06966362
Lead Sponsor VA Office of Research and Development
Conditions Veterans, Tobacco Use Disorder, Cigarette Smoking, Tobacco Dependence
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov