702
Participants
Start Date
March 31, 2011
Primary Completion Date
March 31, 2013
Study Completion Date
July 31, 2013
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.
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.
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"
Nicotine Inhaler
Nicotine inhaler to use as needed after quit date
Duke Center for Nicotine and Smoking Cessation Research, Winston-Salem
Duke Center for Nicotine and Smoking Cessation Research, Raleigh
Duke Center for Nicotine and Smoking Cessation Research, Durham
Duke Center for Nicotine and Smoking Cessation Research, Charlotte
Lead Sponsor
National Institute on Drug Abuse (NIDA)
NIH
Philip Morris USA, Inc.
INDUSTRY
Duke University
OTHER