Please select the eligibility criteria that correspond to the clinical trial below.
Title: An International 7-Week, Double-Blind, Placebo-Controlled, 2-Parallel Group Study to Assess the Efficacy of Dianicline 40 mg BID as an Aid to Smoking Cessation in Cigarette Smokers
Brief Summary: The primary objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are: to assess the craving for cigarettes, nicotine withdrawal symptoms and the safety of dianicline.


Options:
A: Inclusion Criteria:

* Age 18-75 years old
* Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests positive for nicotine metabolites at intake
* Contemplating a smoking cessation attempt in the near future
* Willing to engage in a practice quit attempt during which they will be asked to smoke on one occasion
* Able to give informed consent

Exclusion Criteria:

* Currently meets Diagnostic and Statistical Manual (DSM-IV) criteria for depression, bi-polar disorder, or schizophrenia
* History of attempted suicide or expresses any current suicidal ideation
* Pregnant, breast feeding, or planning to become pregnant within the next 3 months
* Reports desire for immediate treatment of tobacco/nicotine dependence
* Severe impairment of renal function indicated by Glomerular Filtration Rate (GFR) less than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma creatinine adjusted by weight, gender, and age)
B: 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
C: Inclusion Criteria:

* Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months

Exclusion Criteria:

* Insufficient level of motivation
* Another participant in the household
* Patients with current psychotic disorder or major depressive disorder

The investigator will evaluate whether there are other reasons why a patient may not participate.
D: Inclusion Criteria:

* Highly dependent smokers in the stage of preparation according to Prochaska and Di Clemente's stages of change model

Exclusion Criteria:

* History of myocardial infarction in the preceding 3 months
* Pregnancy or breast-feeding
* Use of any form of smokeless tobacco or other nicotine replacement therapy

Answer: C