An Alternative Dosing Schedule of Varenicline for Smoking Cessation
The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Extended Varenicline for Smoking Cessation: A Pilot Study|
- Changes in smoking behavior, as well as smoking satisfaction, craving, and withdrawal. [ Time Frame: daily ] [ Designated as safety issue: Yes ]
- Rates of smoking cessation. [ Time Frame: 12 weeks after quit date. ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||November 2013|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
drug plus counseling.
variable dosing schedule
Other Name: Chantix
Active Comparator: placebo
placebo plus counseling
This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Martin C Mahoney, MD, PhD||Roswell Park Cancer Institute|