Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation
Brief Summary: This study has three main aims. Aim 1: To provide initial data on the efficacy of combined Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit). Aim 2: To explore the possibility that SGR+VN will be particularly efficacious among smokers with higher background levels of Cue Reactivity (CR), as assessed at the start of the study, using a classic experimental smoking CR paradigm. Aim 3: To explore possible mechanisms underlying the effects of SGR+VN, by assessing potential mediators (i.e., self-efficacy, cue-induced cravings) of treatment effects.


Options:
A: Inclusion Criteria:

* Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day

Exclusion Criteria:

* Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.
B: Inclusion Criteria:

* Current cigarette smoker
* Averages at least 10 cigarettes/day for 5 or more years
* DSM-IV diagnosis of Nicotine Dependence
* Breath carbon monoxide \> 6 ppm
* Motivated to quit: score \> 8 on Contemplation Ladder
* Age \> 18 years

Exclusion Criteria:

* Current illicit substance use
* Other tobacco use (e.g., cigar, pipe)
* History of psychosis
* Past or current cardiovascular disease
* Impaired renal functioning
* Pregnancy
* Nursing
* Current treatment for smoking cessation
* Clinically significant depressive symptoms (CES-D \> 16)
* Current suicidal ideation
C: Inclusion Criteria:

* Structured Clinical Interview (SCID) derived DSM-IV diagnoses of Bipolar Disorder (Type I or II), and Nicotine Dependence
* Young Mania Rating Scale Total Score \<12 at study entry
* HAM-D 17-Item Score \>5 and \<24 at study entry
* Fagerstrom Test for Nicotine Dependence (FTND) score of 5 or higher
* Be able to provide informed consent to participate in this study as judged by clinical evaluation, and scoring at least 80% on a post-consent "test"
* Smoking at least 10 cigarettes per day (confirmed by an expired breath CO level \>10 ppm and a plasma cotinine level \>150 ng/ml at baseline)
* Be motivated to quit smoking within 30 days of initial evaluation, as assessed by a score of 7 or higher on the Contemplation Ladder assessment tool
* On a stable dose of a mood stabilizer for at least 1 month (e.g. lithium, valproate, carbamazepine, atypical antipsychotic)
* Judged by the study psychiatrists and/or trained psychiatric clinicians to be in remission from active manic, hypomanic, major depressive and psychotic symptoms based on a clinical interview and SCID-IV ≥1 month prior to study enrollment

Exclusion Criteria:

* Meet criteria for current abuse or dependence for any other alcohol or illicit substance within the past 3 months of study enrollment
* Current evidence by SCID-IV and clinical evaluation of suicidality, homicidality or psychosis
* Meet DSM-IV criteria for current major depression at the time of baseline evaluation
* A history of hypersensitivity or other known adverse reactions (e.g. hyperstimulation, severe agitation) to varenicline.
* Serious medical conditions (i.e. a history of severe cardiac, renal or hepatic disease, diabetes mellitus or thyroid abnormalities)
* EKG abnormalities
* Prescription of Nicotine Replacement Therapies (NRTs) including patches, gum, lozenges or inhalers
* Prescription of monoamine oxidase inhibitors (MAO-I's) including selegiline or moclobemide
* Prescription of varenicline
* Prescription of bupropion SR
* The presence of manic, mixed manic or hypomanic symptoms in the past one month prior to study enrollment.
* A lifetime history of antidepressant-induced mania or hypomania
* A history of suicidal ideation while taking antidepressants
D: Inclusion Criteria:

* Stable on methadone maintenance (an individual is considered 'stable' if they have had a 4 week constant/fixed dose of methadone by self report and verified by B.C. Pharmanet review)
* Subjects must have smoked at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year
* Ages 19 to 75 years (inclusive) and motivated to quit smoking
* Should read and understand English
* For female subjects:

  * instructed and agrees to avoid pregnancy through 30 days after the last dose of study medication
  * has a negative urine pregnancy test at screening
  * agrees to use birth control method(s) for duration of the study
* Should be available by telephone

Exclusion Criteria:

* Subjects who have used varenicline previously or are currently on other Nicotine Replacement Therapy or pharmacotherapy for smoking cessation (e.g., nicotine patch, zyban or wellbutrin)
* Subjects who have a prior or current history of depression, bipolar affective disorder or a prior or current history of psychotic episodes or suicidal ideation (on the basis of self-report augmented by medical chart review where appropriate and/or corroborating history with previous or current health care provider)
* Subjects who have not reached a stable dose of methadone in their methadone maintenance therapy (4 weeks at a constant/fixed dose of methadone by self-report and verified by B.C. Pharmanet review)
* Pregnancy or currently nursing

Answer: B