Measuring Smoking Behaviors While Using Varenicline
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline
Intervention description: Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking; nicotine; varenicline

Summary:

      This study will demonstrate the behavioral responses to varenicline, helping to better
      understand its mechanisms. Hypotheses for the study are to observe decreases in smoking
      topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases
      on day 21 relative to day 7 during varenicline treatment. We also propose to examine if
      extended duration of treatment has clinical significance in decreasing smoking behaviors,
      thus increasing the efficacy of varenicline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  self report minimum 10 daily cigarettes

          -  self report smoking every day past 5 years

          -  between the ages 21-65

          -  self report intention to try to quit smoking in the next 6 months

        Exclusion Criteria:

          -  self reported use of any nicotine-containing products other than non-menthol
             cigarettes

          -  self reported history or current treatment of substance abuse (other than nicotine
             dependence)

          -  self reported alcohol use greater than 25 standard drinks per week;

          -  currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy
             screen)

          -  self reported history or current diagnosis of any Axis 1 disorders except past
             depression

          -  self reported serious or unstable disease within past year

          -  self reported history of epilepsy or seizure disorder;

          -  self reported history or current diagnosis of COPD (chronic obstructive pulmonary
             disease), cardiovascular disease, heart attack, or uncontrolled hypertension

          -  self reported kidney function impairment

          -  any current or recent (30 day) use of: smoking cessation medications, anti-psychotics,
             anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing
             medications

          -  less than 5 years of daily smoking

          -  any medical condition or concomitant medication that could compromise participant
             safety or treatment

          -  provide a baseline carbon monoxide (CO) reading < 10 ppm

          -  self reported use of non filtered cigarettes

          -  inability to provide informed consent or complete any of the study tasks as determined
             by the Principal Investigator and/or Study Physician