Varenicline for Smoking Reduction in Veterans Not Ready To Quit

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

Interventions

DRUG

Motivation-Phase Varenicline

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.

DRUG

Motivation-Phase Nicotine Mini-Lozenge

NRT mini-lozenge reduction dosing will start when participants initiate Motivation-phase treatment: 2-mg mini-lozenges in place of cigarettes (5-15/day).

DRUG

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-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

Cessation-Phase Varenicline

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Jessica Megan Cook, PhD · William S. Middleton Memorial Veterans Hospital, Madison, WI

• Neal M Doran, PhD · VA San Diego Healthcare System, San Diego, CA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2030-06-28

Completion

2030-06-28

FDA Drug

Yes

Countries

• United States

Study Locations