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.

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.

• Drug: varenicline
  variable dosing schedule
  Other Name: Chantix
• Drug: placebo
  placebo

• Experimental: varenicline
  drug plus counseling.
  Intervention: Drug: varenicline
• Active Comparator: placebo
  placebo plus counseling
  Intervention: Drug: placebo

Inclusion Criteria:

• 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.

Exclusion Criteria:

• serious medical condition
• depression or mental health condition requiring treatment in the past year
• history of panic disorder, psychosis, bipolar disorder
• alcohol or drug abuse in the past year
• use of tobacco products other than cigarettes
• current use of other cessation pharmacotherapies
• pregnancy/planned pregnancy.