Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation|
- Quit rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]The quit rate at 4 months will be compared between the 2 groups, using a logistic regression analysis with a 2-side 95% confidence interval.
- Incremental cost per quit [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]Will be calculated by comparing the quit rates between the 2 conditions.
|Study Start Date:||October 2012|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I (varenicline)
Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks.
Active Comparator: Arm II (nicotine patch)
Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.
Drug: nicotine patch
I. To determine if mail delivery of 12 weeks of varenicline results in improved smoking cessation outcomes relative to nicotine replacement therapy (NRT) in 300 smokers.
II. To determine if delivery of varenicline is cost-effective as compared to nicotine patch.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo general smoking cessation counseling and receive varenicline orally (PO) twice daily (QD) on days 1-28. Courses repeat every 28 days for up to 12 weeks.
ARM II: Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.
After completion of study treatment, patients are followed up at 4 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771627
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Martin Mahoney||Roswell Park Cancer Institute|