NCT02271919

Varenicline and Combined NRT for Smoking Cessation

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 631 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Primary Objectives: To estimate (a) the effects at 12 weeks of either continuing on their current medication, switching to the other medication, or increasing the dose of their current medication among smokers initially treated with either varenicline 2 mg (VAR) or nicotine patch + ad lib lozenge (combined nicotine replacement therapy; CNRT) but who relapsed to smoking by week 6 of treatment, and (b) the effects of 12 weeks of continued treatment on either VAR or CNRT among individuals who are abstinent from smoking at 6 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 who are abstinent at week 6 will continue treatment for an additional 6 weeks. Patients who fail to achieve abstinence at week 6 are re-randomized to 6 additional weeks of therapy consisting of either continuing on the same treatment, switching to CNRT, or receiving high-dose varenicline. 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 who are abstinent at week 6 will continue treatment for an additional 6 weeks. Patients who fail to achieve abstinence at week 6 are re-randomized to 6 additional weeks of therapy consisting of either continuing on the same treatment, switching to varenicline, or receiving high-dose CNRT. 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.

Conditions

• Cigarette Smoker
• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	Nicotine Lozenge	Given PO
DRUG	Nicotine Patch	Given via patch
OTHER	Placebo	Given PO or via patch
OTHER	Tobacco Cessation Counseling	Receive behavioral smoking cessation counseling
DRUG	Varenicline	Given PO

Timeline

• Start date: 2015-05-14
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2014-10-22
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study