VeteransPhase 4NCT06966362
Varenicline for Smoking Reduction in Veterans Not Ready To Quit
A Phase 4 study testing Motivation-Phase Varenicline, Motivation-Phase Nicotine Mini-Lozenge and Cessation-Phase Combination Nicotine Replacement Therapy (NRT) in people with Veterans and Tobacco Use Disorder, run by VA Office of Research and Development at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Veterans, Tobacco Use Disorder, Cigarette Smoking
- What is being tested?
- Motivation-Phase Varenicline, Motivation-Phase Nicotine Mini-Lozenge and Cessation-Phase Combination Nicotine Replacement Therapy (NRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Aug 2026to 28 Jun 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Recruiting
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Jean Beckham, PhD, jean.beckham@va.gov
- Active, not recruiting
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
- Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Patrick Hammett, PhD, patrick.hammett@va.gov
- Recruiting
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Neal Doran, PhD, neal.doran@va.gov
About this study
Official title: Varenicline for Smoking Reduction in Veterans Unwilling to Quit
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.
Read the detailed description
Evidence-based smoking cessation treatments can double smoking abstinence rates, yet these treatments are underused by the millions of Veterans who smoke. One reason for this is that the great majority of people who smoke are not ready to make a quit attempt when cessation treatment is offered (70-90%). An important public health goal is to increase engagement of people not ready to quit smoking in highly effective treatment that prepares them to make quit attempts and ultimately achieve abstinence (i.e., Motivation-phase treatment; MPT). MPT typically combines smoking reduction counseling with nicotine replacement therapy (NRT). Although offering NRT Motivation-phase treatment (NRT MPT) in healthcare settings increases the reach of tobacco treatment, such interventions only weakly affect long-term abstinence. It is vital that the investigators develop more effective MPTs that increase quit attempts and quitting success in people not ready to quit. Varenicline, the most effective single agent smoking cessation pharmacotherapy, holds great promise as an intervention for people who are not ready to make a quit attempt. The investigators propose that MPT will be markedly more effective if it involves the use of varenicline (vs. NRT) because it will more effectively reduce smoking reward, affective withdrawal, and tonic craving. Initial evidence suggests that varenicline increases quitting motivation in those not ready to quit, but the extant studies have not 1) directly evaluated varenicline effectiveness in this population and 2) compared varenicline MPT with NRT MPT, the current standard treatment for those not ready to make a quit attempt. The goal of this study is to evaluate whether varenicline MPT is especially effective and cost-effective relative to NRT MPT, in Veterans who are willing to reduce but not quit smoking. This study will compare the use of varenicline MPT vs. NRT MPT on: biochemically verified point-prevalence abstinence at 1 year (primary outcome), quit attempts, and cessation treatment use.
This study is a 2-group randomized controlled trial that will enroll 400 adults from three geographically diverse VA hospitals who smoke 5 cigarettes/day and do not want to quit smoking in the next 30 days but are willing to cut down. Participants will be randomized to one of two 12-week MPT groups: (1) varenicline, or (2) NRT (2 milligrams (mg) mini-lozenges). All participants will receive 5 phone counseling sessions focused on smoking reduction during the 12-week MPT. Any participants who decide to try quitting will receive smoking cessation treatment involving continued use of their assigned study medication and cessation counseling.
- Conditions
- Veterans, Tobacco Use Disorder, Cigarette Smoking, Tobacco Dependence
- Being tested
- Motivation-Phase Varenicline, Motivation-Phase Nicotine Mini-Lozenge, Cessation-Phase Combination Nicotine Replacement Therapy (NRT), Cessation-Phase Varenicline, Motivation-Phase Counseling
- Keywords
- Varenicline, Tobacco use disorder, Veterans, Quit attempts, Cigarette smoking, Motivation phase treatment, Nicotine replacement therapy, Smoking reduction, Smoking abstinence
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking, Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivation-Phase VareniclineDrug
Also called Chantix
Varenicline reduction dosing will start when participants initiate Motivation-phase treatment: 0.5 milligrams (mg) 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.
Motivation-Phase Nicotine Mini-LozengeDrug
Also called Nicorette
NRT mini-lozenge reduction dosing will start when participants initiate Motivation-phase treatment: 2-milligrams (mg) mini-lozenges in place of cigarettes (5-15/day).
Cessation-Phase Combination Nicotine Replacement Therapy (NRT)Drug
Also called Nicorette, Nicoderm
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-milligrams (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).
Cessation-Phase VareniclineDrug
Also called Chantix
Varenicline cessation dosing will start one week prior to their target quit date (TQD): 0.5 milligrams (mg) 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.
Motivation-Phase CounselingBehavioural
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.
Cessation-Phase CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivation-Phase Varenicline | Experimental | Varenicline use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking. Receives: Drug: Motivation-Phase Varenicline; Drug: Cessation-Phase Varenicline; Behavioral: Motivation-Phase Counseling; Behavioral: Cessation-Phase Counseling |
| Motivation-Phase Nicotine Mini-Lozenge | Active comparator | NRT mini-lozenge use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking. Receives: Drug: Motivation-Phase Nicotine Mini-Lozenge; Drug: Cessation-Phase Combination Nicotine Replacement Therapy (NRT); Behavioral: Motivation-Phase Counseling; Behavioral: Cessation-Phase Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence
Participants who report 7-day point-prevalence abstinence from cigarettes at the 6 month follow-up will mailed a saliva collection kit that will test cotinine and anabasine to validate self-reported abstinence from combusted tobacco.
Measured: 6 months post-study entry
Secondary outcomes (3)
Making a quit attempt lasting 24 hours
Making a quit attempt lasting at least 24 hours by 6 and 12 months; coded as binary (0 or 1).
Measured: 6 and 12 months post-study entry
Cessation treatment entry
Entering cessation treatment; coded as binary (0 or 1)
Measured: 6 months post-study entry
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.
Measured: 12 months post-study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start17 Aug 2026
- Primary completion28 Jun 2030 (estimated)
- Study completion28 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VeteransStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two 12-week Motivation-phase treatment groups: (1) varenicline, or (2) NRT (2 mg mini-lozenges).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jessica Megan Cook, PhD, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WINeal M Doran, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966362
- Sponsor's protocol ID
- NURA-007-24F
- Status last verified
- Aug 2026
- First submitted
- 2 May 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified dataset will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline for Smoking Reduction in Veterans Unwilling to Quit
- ClinicalTrials.gov ID
- NCT06966362
- Acronym / sponsor ID
- NURA-007-24F
- Conditions
- Veterans, Tobacco Use Disorder, Cigarette Smoking, Tobacco Dependence
- Keywords
- Varenicline, Tobacco use disorder, Veterans, Quit attempts, Cigarette smoking, Motivation phase treatment, Nicotine replacement therapy, Smoking reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 28 Jun 2030 (estimated)
- Study completion
- 28 Jun 2030 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Evidence-based smoking cessation treatments can double smoking abstinence rates, yet these treatments are underused by the millions of Veterans who smoke. One reason for this is that the great majority of people who smoke are not ready to make a quit attempt when cessation treatment is offered (70-90%). An important public health goal is to increase engagement of people not ready to quit smoking in highly effective treatment that prepares them to make quit attempts and ultimately achieve abstinence (i.e., Motivation-phase treatment; MPT). MPT typically combines smoking reduction counseling with nicotine replacement therapy (NRT). Although offering NRT Motivation-phase treatment (NRT MPT) in healthcare settings increases the reach of tobacco treatment, such interventions only weakly affect long-term abstinence. It is vital that the investigators develop more effective MPTs that increase quit attempts and quitting success in people not ready to quit. Varenicline, the most effective single agent smoking cessation pharmacotherapy, holds great promise as an intervention for people who are not ready to make a quit attempt. The investigators propose that MPT will be markedly more effective if it involves the use of varenicline (vs. NRT) because it will more effectively reduce smoking reward, affective withdrawal, and tonic craving. Initial evidence suggests that varenicline increases quitting motivation in those not ready to quit, but the extant studies have not 1) directly evaluated varenicline effectiveness in this population and 2) compared varenicline MPT with NRT MPT, the current standard treatment for those not ready to make a quit attempt. The goal of this study is to evaluate whether varenicline MPT is especially effective and cost-effective relative to NRT MPT, in Veterans who are willing to reduce but not quit smoking. This study will compare the use of varenicline MPT vs. NRT MPT on: biochemically verified point-prevalence abstinence at 1 year (primary outcome), quit attempts, and cessation treatment use.
This study is a 2-group randomized controlled trial that will enroll 400 adults from three geographically diverse VA hospitals who smoke 5 cigarettes/day and do not want to quit smoking in the next 30 days but are willing to cut down. Participants will be randomized to one of two 12-week MPT groups: (1) varenicline, or (2) NRT (2 milligrams (mg) mini-lozenges). All participants will receive 5 phone counseling sessions focused on smoking reduction during the 12-week MPT. Any participants who decide to try quitting will receive smoking cessation treatment involving continued use of their assigned study medication and cessation counseling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two 12-week Motivation-phase treatment groups: (1) varenicline, or (2) NRT (2 mg mini-lozenges).
| Arm | Type | Receives |
|---|---|---|
| Motivation-Phase Varenicline | Experimental | Drug: Motivation-Phase Varenicline, Drug: Cessation-Phase Varenicline, Behavioral: Motivation-Phase Counseling, Behavioral: Cessation-Phase CounselingVarenicline 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 comparator | Drug: Motivation-Phase Nicotine Mini-Lozenge, Drug: Cessation-Phase Combination Nicotine Replacement Therapy (NRT), Behavioral: Motivation-Phase Counseling, Behavioral: Cessation-Phase CounselingNRT mini-lozenge use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivation-Phase VareniclineAlso: ChantixVarenicline reduction dosing will start when participants initiate Motivation-phase treatment: 0.5 milligrams (mg) 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. | Drug | Motivation-Phase Varenicline |
| Motivation-Phase Nicotine Mini-LozengeAlso: NicoretteNRT mini-lozenge reduction dosing will start when participants initiate Motivation-phase treatment: 2-milligrams (mg) mini-lozenges in place of cigarettes (5-15/day). | Drug | Motivation-Phase Nicotine Mini-Lozenge |
| Cessation-Phase Combination Nicotine Replacement Therapy (NRT)Also: Nicorette, NicodermCombination NRT (nicotine patch + nicotine mini-lozenge) cessation dosing will begin on the target quit day: if smoking >10 cigarettes/day = 8 weeks of 21-milligrams (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). | Drug | Motivation-Phase Nicotine Mini-Lozenge |
| Cessation-Phase VareniclineAlso: ChantixVarenicline cessation dosing will start one week prior to their target quit date (TQD): 0.5 milligrams (mg) 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. | Drug | Motivation-Phase Varenicline |
| Motivation-Phase CounselingAll 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. | Behavioural | Motivation-Phase Nicotine Mini-Lozenge, Motivation-Phase Varenicline |
| Cessation-Phase CounselingAll 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. | Behavioural | Motivation-Phase Nicotine Mini-Lozenge, Motivation-Phase Varenicline |
Primary outcome
7-day point prevalence abstinence
Time frame: 6 months post-study entry
Participants who report 7-day point-prevalence abstinence from cigarettes at the 6 month follow-up will mailed a saliva collection kit that will test cotinine and anabasine to validate self-reported abstinence from combusted tobacco.
3 secondary outcomes
Making a quit attempt lasting 24 hours
Time frame: 6 and 12 months post-study entry
Cessation treatment entry
Time frame: 6 months post-study entry
Biochemically confirmed 7-day point-prevalence abstinence
Time frame: 12 months post-study entry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. Deidentified dataset will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Megan Cook, PhD principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
Neal M Doran, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Motivation-Phase Varenicline, Motivation-Phase Nicotine Mini-Lozenge and Cessation-Phase Combination Nicotine Replacement Therapy (NRT) in people with Veterans and Tobacco Use Disorder, run by VA Office of Research and Development at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica M Cook, PhD ((608) 256-1901, Jessica.Cook2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence abstinence (time frame: 6 months post-study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.