Varenicline for Smoking Reduction in Veterans Unwilling to Quit
VA Office of Research and Development
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.
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 wit…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 (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 Exclusion Criteria: * Unable to give informed, voluntary consent to participate * Current use of any pharmacotherapy for smoking cessation * Use of non-cigarette toba…
Interventions
- DrugMotivation-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.
- DrugMotivation-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).
- DrugCessation-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).
- DrugCessation-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.
Locations (4)
- VA San Diego Healthcare System, San Diego, CASan Diego, California
- Minneapolis VA Health Care System, Minneapolis, MNMinneapolis, Minnesota
- Durham VA Medical Center, Durham, NCDurham, North Carolina
- William S. Middleton Memorial Veterans Hospital, Madison, WIMadison, Wisconsin