Varenicline and Combined NRT for Smoking Cessation

Tobacco Use Disorder Clinical Trial

Official title: Varenicline and Combined NRT for Initial Smoking Cessation and Rescue Treatment in Smokers: A Randomized Pilot Trial

Status Active, not recruiting

Clinical Trial Summary

This randomized pilot phase IV trial studies the side effects and how well varenicline works compared to nicotine replacement therapy in helping patients that smoke to quit. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming. Nicotine replacement therapy consists of nicotine patches and lozenges. It is not yet known if varenicline is more effective than nicotine replacement therapy in helping patients quit smoking.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To estimate the main effects of varenicline 2 mg (VAR) and nicotine patch + lozenge (NPL) on smokers who remain on these medications throughout the trial.

II. To estimate the probability that abstinence at twelve weeks as a function of treatment assignment at six weeks (augmentation) is moderated by initial treatment assignment (i.e. at baseline).

III. To estimate the probability that abstinence at twelve weeks as a function of treatment assignment at six weeks (switching) is moderated by initial treatment assignment (i.e. at baseline).

IV. To estimate the probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge (NPL) for six weeks.

V. To estimate the probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with VAR for six weeks.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive varenicline orally (PO) once daily (QD) or twice daily (BID), placebo patches QD, and placebo lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients that are abstinent at week 6 may continue treatment for an additional 6 weeks. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.

GROUP II: Patients receive placebo tablets PO QD or BID, nicotine patches QD, and nicotine lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients that are abstinent at week 6 may continue treatment for an additional 6 weeks. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.

Patients who fail to achieve abstinence at week 6 are re-randomized to receive 6 additional weeks of therapy consisting of either a continuation of the same treatment; switching to the untried intervention (either NPL or varenicline); or receive NPL treatment with an additional patch (high-dose NPL) or high-dose varenicline.

After completion of study treatment, patients are followed up at 3 and 6 months. ;

Related Conditions & MeSH terms

• Cigarette Smoker
• Tobacco Use Disorder

• NCT number: NCT02271919
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 14, 2015
• Completion date: June 30, 2025