Varenicline-based approach to help Veterans who smoke see if they can reduce smoking and try to quit
Official title: Varenicline for Smoking Reduction in Veterans Unwilling to Quit
Run by VA Office of Research and Development · NCT06966362 · Data updated 2026-11-12
This study tests whether varenicline, plus motivational support, helps Veterans who aren’t ready to quit reduce smoking and make quit attempts.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 4 sites (San Diego, California and 3 other locations) |
| Status | Recruiting |
| Started | August 17, 2026 |
| Main results expected | June 28, 2030 |
| Study ends | June 28, 2030 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT06966362 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Veterans who smoke at least five cigarettes daily, are not ready to quit within 30 days but are willing to cut down, and can use NRT or varenicline with English proficiency.
✕Probably not a fit
Participants unlikely to benefit include those not interested in pharmacotherapy, unable to consent, currently using smoking-cessation meds, or who smoke non-cigarette tobacco products as their primary tobacco use.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 4 trial examines a varenicline-based motivation-phase treatment to engage Veterans who smoke but are not ready to set a quit date. It compares a varenicline-driven intervention to standard cessation options, aiming to increase quit attempts and long-term abstinence. The study incorporates smoking-reduction counseling, nicotine replacement therapy, and varenicline across different phases to maximize engagement and quitting success. Participants are adults who smoke at least five cigarettes daily, are Veterans, and are medically eligible for the medications. The trial is conducted at multiple VA sites in California, Minnesota, and North Carolina under VA leadership.
Why it matters
Potential benefit: If successful, the approach could increase quit attempts and long-term abstinence, reducing health risks associated with smoking in Veterans.
How similar studies have gone: Previous work suggests varenicline can increase motivation to quit in those not ready to quit, but this specific motivation-phase approach is being tested for effectiveness in the Veteran population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Report smoking an average of 5 or more cigarettes daily for the previous 6 months * Not ready to set a quit date in the next 30 days but willing to cut down on their smoking * Able to read, write, and speak English * Be medically eligible to use study medications (nicotine replacement therapy (NRT) or varenicline) * If female, use an approved method of birth control while using study medication * Be a Veteran Exclusion Criteria: * Unable to give informed, voluntary consent to participate * Current use of any pharmacotherapy for smoking cessation * Use of non-cigarette tobacco products as primary form of tobacco use * Incarceration
Where it's running
-
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States Recruiting -
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States Recruiting -
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States Recruiting -
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States Active not recruiting
Study contacts
- Principal investigator: Jessica Megan Cook, PhD — William S. Middleton Memorial Veterans Hospital, Madison, WI
- Study coordinator: Jessica M Cook, PhD
- Email: Jessica.Cook2@va.gov
- Phone: (608) 256-1901
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.