Varenicline for Smoking Reduction in Veterans Not Ready To Quit
Key facts
- Who runs it
- VA Office of Research and Development
- Where
- Durham, Madison, Minneapolis, and San Diego, United StatesSee the 4 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 400 people, planned
- Started
- 17 Aug 2026
- Expected to end
- 28 Jun 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Motivation-Phase Varenicline
- Motivation-Phase Nicotine Mini-Lozenge
- Cessation-Phase Combination Nicotine Replacement Therapy (NRT)
- Cessation-Phase Varenicline
- Motivation-Phase Counseling
- Cessation-Phase Counseling
- Record updated
- 31 August 2026
Who can take part
- Age
- 21 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in United States
- Durham VA Medical Center, Durham, NCDurham, United StatesContact: Jean Beckham, PhDTaking people
- William S. Middleton Memorial Veterans Hospital, Madison, WIMadison, United StatesContact: Jessica M Cook, PhDNo longer taking part
- Minneapolis VA Health Care System, Minneapolis, MNMinneapolis, United StatesContact: Patrick Hammett, PhDTaking people
- VA San Diego Healthcare System, San Diego, CASan Diego, United StatesContact: Neal Doran, PhDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Motivation-Phase VareniclineTreatment being tested
Varenicline use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.
Treatment: Motivation-Phase Varenicline, Cessation-Phase Varenicline, Motivation-Phase Counseling, and Cessation-Phase Counseling
- Motivation-Phase Nicotine Mini-LozengeExisting treatment, for comparison
NRT mini-lozenge use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.
Treatment: Motivation-Phase Nicotine Mini-Lozenge, Cessation-Phase Combination Nicotine Replacement Therapy (NRT), Motivation-Phase Counseling, and Cessation-Phase Counseling
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Varenicline for Smoking Reduction in Veterans Unwilling to Quit
- Record updated
- 31 August 2026