Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

Inclusion criteria

• 18 years and up.
• Smoked at least 10 cigarettes/day for at least 1 year.
• English speaking and reading.
• Females who are of childbearing potential must practice effective contraception and meet the following criteria:

• Are instructed to avoid pregnancy through 30 days after the last dose of study medication.
• Have a negative urine pregnancy test at baseline.
• 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.
• Willingness to not use illicit drugs during study period including marijuana.

Exclusion criteria

• Any unstable medical condition.
• Unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia.
• Personal history of seizures.
• Closed head trauma with any loss of consciousness or amnesia in the last 5 years.
• A history of closed head trauma with > 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion.
• A history of psychosis, bipolar disorder, bulimia or anorexia nervosa.
• Current depression as assessed by Center for Epidemiologic Studies Depression Scale (CES-D).
• Medications that might affect the outcome measures of nicotine reward, cognition, anxiety, and stress will also be a basis for exclusion. These medications include psychotropic drugs (i.e., anti-psychotic, anti-depressant, anti-anxiety, or stimulant), anti- hypertensive agents (e.g., beta-blockers), and other drugs that can influence the outcome domains.
• Active substance abuse other than nicotine.
• Used an investigational drug within the last 30 days.
• Are currently using a behavioral or pharmacologic tobacco treatment.
• Use of bupropion or varenicline in the previous 30 days.
• Current (past 14 days) use of antipsychotic or antidepressant medications.
• An allergy to bupropion or varenicline.
• Untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100.
• Impaired kidney function (creatinine clearance < 30).
• Having plans to leave the immediate geographical area within 2 months.
• Unwillingness or inability to give written informed consent.

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