Varenicline for Smoking Reduction in Veterans Not Ready To Quit

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

December 1, 2025

Primary Completion Date

September 30, 2030

Study Completion Date

September 30, 2030

Conditions
VeteransTobacco Use DisorderCigarette SmokingTobacco 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.

Trial Locations (4)

92161-0002

VA San Diego Healthcare System, San Diego, CA, San Diego

55417-2309

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis

27705-3875

Durham VA Medical Center, Durham, NC, Durham

53705-2254

William S. Middleton Memorial Veterans Hospital, Madison, WI, Madison

All Listed Sponsors
lead

VA Office of Research and Development

FED