Varenicline for Smoking Reduction in Veterans Not Ready To Quit
1 other identifier
interventional
400
1 country
4
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2026
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2025
CompletedFirst Posted
Study publicly available on registry
May 11, 2025
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2030
Study Completion
Last participant's last visit for all outcomes
June 28, 2030
April 24, 2026
April 1, 2026
4 years
May 2, 2025
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biochemically confirmed 7-day point-prevalence abstinence
Participants who report 7-day point-prevalence abstinence from cigarettes at the 12 month follow-up will mailed a saliva collection kit that will test cotinine and anabasine to validate self-reported abstinence from combusted tobacco.
12 months post-study entry
Secondary Outcomes (3)
7-day point prevalence abstinence
6 months post-study entry
Making a quit attempt lasting 24 hours
6 and 12 months post-study entry
Cessation treatment entry
6 months post-study entry
Study Arms (2)
Motivation-Phase Varenicline
EXPERIMENTALVarenicline use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.
Motivation-Phase Nicotine Mini-Lozenge
ACTIVE COMPARATORNRT mini-lozenge use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.
Interventions
Varenicline reduction dosing will start when participants initiate Motivation-phase treatment: 0.5mg once daily for 3 days, increasing to 0.5mg twice daily for days 4 to 7, and then to the maintenance dose of 1mg twice daily for the duration of the 12-week reduction regimen.
NRT mini-lozenge reduction dosing will start when participants initiate Motivation-phase treatment: 2-mg mini-lozenges in place of cigarettes (5-15/day).
Combination NRT (nicotine patch + nicotine mini-lozenge) cessation dosing will begin on the target quit day: if smoking \>10 cigarettes/day = 8 weeks of 21-mg, 2 weeks of 14-mg, and 2 weeks of 7-mg nicotine patches; if smoking 10 cigarettes/day = 10 weeks of 14-mg and 2 weeks of 7-mg nicotine patches. All participants will receive 2 or 4 mg mini-lozenge for the 12-week cessation period (9/day, 1 piece every 1-2/hours).
Varenicline cessation dosing will start one week prior to their TQD: 0.5mg once daily for 3 days, increasing to 0.5mg twice daily for days 4 to 7, and then to the maintenance dose of 1mg twice daily for the remainder of the 12-week cessation regimen.
All participants receive motivation-phase counseling. Motivation-phase counseling involves 5, 10-15-minute counseling calls. The counselor will work with participants on smoking control skills selected by the participant, such as avoidance of smoking cues, reducing smoking heaviness/contexts, developing urge coping skills, or finding support from friends and family. Counseling will emphasize setting realistic and achievable smoking control goals. Counseling will also emphasize competence and self-efficacy, which will be linked to success in smoking control.
All participants who enter cessation treatment will be offered 4, 10-15-minute counseling calls. The first counseling session involves pre-quit preparation, and can occur any time before the target quit day. The other 3 counseling calls will be scheduled for 1 day, 1 week, and 4 weeks after the target quit date. Cessation counseling will be based on treatment guidelines and will review instructions for when to start cessation medication, the timing of the quit day (relative to medication start), and medication adherence. Counseling will involve problem solving and skill development.
Eligibility Criteria
You may qualify if:
- 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 (NRT or varenicline)
- If female, use an approved method of birth control while using study medication
- Be at least 21 years old
- Be a Veteran
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309, United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875, United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Megan Cook, PhD
William S. Middleton Memorial Veterans Hospital, Madison, WI
- PRINCIPAL INVESTIGATOR
Neal M Doran, PhD
VA San Diego Healthcare System, San Diego, CA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Only the outcome assessors will be blinded to treatment assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2025
First Posted
May 11, 2025
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
June 28, 2030
Study Completion (Estimated)
June 28, 2030
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Deidentified dataset will be shared upon request.