Recruiting

Varenicline

Sponsor:

VA Office of Research and Development

Code:

NCT06966362

Conditions

Veterans

Tobacco Use Disorder

Cigarette Smoking

Tobacco Dependence

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Motivation-Phase Varenicline

Motivation-Phase Nicotine Mini-Lozenge

Cessation-Phase Combination Nicotine Replacement Therapy (NRT)

Cessation-Phase Varenicline

Motivation-Phase Counseling

Study Details

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.

Conditions

Veterans

Tobacco Use Disorder

Cigarette Smoking

Tobacco Dependence

Study ID

NCT06966362

Start date

Aug 17, 2026

Status verified date

Aug, 2026

Completion date

Jun 28, 2030

Anticipated

Primary completion date

Jun 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Motivation-Phase Varenicline

Varenicline use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.

active comparator: Motivation-Phase Nicotine Mini-Lozenge

NRT mini-lozenge use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.

Interventions

Motivation-Phase Varenicline

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-Lozenge

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)

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 Varenicline

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 Counseling

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 Counseling

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.

Primary outcome measure

  • 7-day point prevalence abstinence [ Time Frame: 6 months post-study entry ]

Central Contacts and Locations

Central contacts

Jessica M Cook, PhD

(608) 256-1901Jessica.Cook2@va.gov

Elana G Brubaker, MSW BS

(608) 256-1901elana.brubaker@va.gov

Locations

VA San Diego Healthcare System, San Diego, CA

Recruiting

San Diego, California, United States, 92161-0002

Contacts

Neal Doran, PhD

neal.doran@va.gov

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Patrick Hammett, PhD

patrick.hammett@va.gov

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Jean Beckham, PhD

jean.beckham@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Varenicline
  • Tobacco use disorder
  • Veterans
  • Quit attempts
  • Cigarette smoking
  • Motivation phase treatment
  • Nicotine replacement therapy
  • Smoking reduction
  • Smoking abstinence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-31.