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An Alternative Dosing Schedule of Varenicline for Smoking Cessation
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Condition or disease
Drug: vareniclineDrug: placebo
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.
Change in Smoking Behavior [ Time Frame: Change in cigarettes per day from Week 2 to Week 5 ]
Change in cigarettes per day from Week 2 to Week 5
Secondary Outcome Measures
Rates of Smoking Cessation. [ Time Frame: 12 weeks after quit date. ]
To parallel most clinical trials of varenicline, we focused on CO-verified (<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
currently smoking at least 15 cigarettes daily
in good health
able to read and speak English fluently
have a home telephone and plan to reside in Western New York for 6 months
willing to make quit attempt
signed informed consent
who planned quit attempt.
serious medical condition
depression or mental health condition requiring treatment in the past year
history of panic disorder, psychosis, bipolar disorder