Concurrent Bupropion / Varenicline for Smoking Cessation

PHASE3CompletedINTERVENTIONAL
Enrollment

702

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

March 31, 2013

Study Completion Date

July 31, 2013

Conditions
Nicotine Dependence
Interventions
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

Trial Locations (4)

27103

Duke Center for Nicotine and Smoking Cessation Research, Winston-Salem

27609

Duke Center for Nicotine and Smoking Cessation Research, Raleigh

27705

Duke Center for Nicotine and Smoking Cessation Research, Durham

28210

Duke Center for Nicotine and Smoking Cessation Research, Charlotte

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

Philip Morris USA, Inc.

INDUSTRY

lead

Duke University

OTHER

NCT01303861 - Concurrent Bupropion / Varenicline for Smoking Cessation | Biotech Hunter | Biotech Hunter