NCT01303861

Concurrent Bupropion / Varenicline for Smoking Cessation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 702 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	Varenicline	For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
DRUG	Bupropion	For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
DRUG	Nicotine patches	Nicotine Replacement Therapy Groups: 1. For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or 2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. Varenicline and varenicline in combination with bupropion groups: 1. For smokers with high baseline CO: 42 mg/24 h for 1 week 2. For smokers with low baseline CO: 21 mg/24 h for 1 week
DRUG	Nicotine Inhaler	Nicotine inhaler to use as needed after quit date

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-03-01
• Completion: 2013-07-01
• First posted: 2011-02-25
• Last updated: 2014-08-06
• Results posted: 2014-08-01

Locations

4 sites across 1 country: United States