Effects of Chantix on Relapse Prevention for Smoking Cessation

The proposed human experiment will test the validity of a novel paradigm that may provide a method for distinguishing compounds that are likely to have efficacy from those that are not, before they are tested in more costly large-scale clinical trials. Specifically, in a within-subject (cross-over) behavioral pharmacology investigation of 60 smokers, we will test the effects of varenicline versus placebo on smoking behavior in the natural environment following a 3-day period of monitored abstinence and a programmed cigarette lapse. A positive signal for varenicline effects in this study would provide support for the sensitivity of the paradigm. In addition, following completion of all assessments, participants will be followed in a 13-week open-label varenicline smoking cessation trial to determine whether response to varenicline in the laboratory study predicts clinical response in the open-label trial.

Inclusion criteria

• Eligible participants will be 68 (34 male and 34 female) smokers aged 18-65, who smoke ≥ 10 cigarettes per day, provide a baseline CO reading ≥ 10 ppm and who plan to live in the area for the next 6-months.

Exclusion criteria

• Smoking Behavior

• Use of chewing tobacco or snuff
• Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
• Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
• Provide a baseline CO reading < 10 ppm

Alcohol/Drug Exclusion Criteria

• History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants)
• Current alcohol consumption that exceeds >25 standard drinks/week

Medication Exclusion Criteria

• Current use or recent discontinuation (within last 14-days) of the following medications:

• Any form of smoking cessation medication (zyban, wellbutrin, wellbutrin SR, Chantix, NRT)
• Any form of anti-psychotic medications that includes:

• antipsychotics,
• atypical antipsychotics,
• mood-stabilizers,
• anti-depressants (tricyclics, SSRI's, MAOI's),
• anti-panic agents,
• anti-obsessive agents,
• anti-anxiety agents, and
• stimulants (e.g., Provigil, Ritalin).
• Medication for chronic pain
• Anti-coagulants
• Any heart medications
• Daily medication for asthma

Medical Exclusion Criteria

• Women who are pregnant, planning a pregnancy, or lactating.
• History or current diagnosis of psychosis, major depression or bipolar disorder, schizophrenia, or any Axis 1 disorder as identified by the SCID.
• Serious or unstable disease within the past 6 months (e.g., cancer [except melanoma], heart disease, HIV).
• History of epilepsy or a seizure disorder.
• History or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia (>100 beats/minute); history or current diagnosis of COPD, cardiovascular disease (stroke, angina, coronary heart disease), heart attack in the last 6 months, uncontrolled hypertension (SBP>150 or DBP>90)
• History of Kidney and/or liver failure (including transplant).
• Wears a device to aid in hearing (hearing aid, cochlear implant, etc.).
• Hearing threshold < 40 dB SPL at 1000 Hz.
• Color blindness.

General Exclusion

• Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
• Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
• Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.