Human Laboratory Study Of Varenicline in Smokers

Inclusion Criteria

• •1.1. Who. Subjects will be women and men between the ages of 18 and 40 who have smoked at least 10 cigarettes per day for at least 1 year. They will respond to requests in the public media for individuals who are interested in quitting smoking.
• •1.2. Total sample/Number per group. The total randomized sample size will equal 20 subjects, equally distributed across the two medication groups.
• •1. 18 years to 60 years.
• •2. Smoke Marlboro Lights (This criterion was selected to reduce inter-subject variation in response variables as has been done in many human laboratory studies of smoking behavior. Over 40% of all smokers smoke some type of the Marlboro brand of cigarette (Substance Abuse and Mental Health Services Administration, 2005). Based on telephone screen data for 767 subjects collected at TURC, Marlboro Light cigarettes are the most common type of Marlboro smoked in our sampling population (158/252 Marlboro users \[63%\]). Therefore, we have decided to only enroll those smoking Marlboro Light cigarettes, non-menthol).
• •3. Smoked at least 10 cigarettes/day for at least 1 year.
• •4. English speaking and reading.
• •5. Females who are of childbearing potential must practice effective contraception and meet the following criteria:
• •1. Are instructed to avoid pregnancy through 30 days after the last dose of study medication.
• •2. Have a negative urine pregnancy test at baseline.
• •3. Agree to use of the birth control methods listed: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo-Provera) for at least one month prior to entering the study and will continue its use through at least 30 days after the last dose of the study medication. A barrier method of contraception (e.g., condom or diaphragm with spermicide) while participating in the study and 30 days after the last dose of study medication.
• •6. Willingness to not use illicit drugs during study period including marijuana.