Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: Inclusion Criteria:

* Age 18 or older
* English speaking
* Smoked at least 100 cigarettes/lifetime
* Smokes 5 or more cigarettes per day
* Interested in quitting smoking (preparation or contemplation state of change)
* Enrolled in Einstein/Montefiore methadone program for 3 or more months
* Stable methadone dose for 2 weeks
* Agree to use contraception throughout the trial (among women with reproductive potential)
* Willing to participate in all study components
* Able to provide informed consent

Exclusion Criteria:

* Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
* Psychiatric instability
* Women who are pregnant, breastfeeding, or contemplating pregnancy
* Creatinine clearance less than 30 mL/min
B: Inclusion Criteria:

* Healthy male and female adolescents (12 - 16 years inclusive) with a total body weight greater than 30 kg who currently smoke an average of at least 3 cigarettes per day.

Exclusion Criteria:

* Male and female subjects with a positive urine drug screen and female subjects with a positive pregnancy test.
C: Inclusion Criteria:

* Age 18 years or older
* English speaking
* Smoked at least 100 cigarettes/lifetime
* Smoke 5 or more cigarettes per day
* Interested in quitting smoking (preparation or contemplation stage of change)
* Enrolled in Einstein/Montefiore methadone program for 12 weeks or more
* Receiving methadone in clinic three, four, five or six times per week
* No more than 2 methadone clinic misses in prior 14 days
* Agree to use contraception for the duration of the trial (among women with reproductive potential)
* Willing to participate in all study components
* Able to provide informed consent

Exclusion Criteria:

* Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
* Psychiatric instability
* Women who are pregnant, breastfeeding, or contemplating pregnancy
* Creatinine clearance \<30 mL/min
D: Inclusion Criteria:

* 14 to 17 years of age
* Smoked at least 6 cigarettes per day
* Exhaled CO greater than or equal to 10 ppm
* Made at least two previous quit attempts
* Weighed at least 90 pounds
* Able to read English at least the 6th grade level
* Motivated to quit smoking as evidenced by willingness to commit to study protocol requirements for the duration of the study
* provided active parental consent and youth assent

Exclusion Criteria:

* Current use of tobacco products other than cigarettes, unless willing to abstain from these products for the study duration
* Current use of other treatments for smoking cessation
* History or current diagnosis of panic disorder, psychosis, bipolar disorder, or eating disorder
* History of abuse or dependence on alcohol or other recreational or prescription drugs in the three months preceding the study
* Current evidence of clinical depression or Attention Deficit/Hyperactivity Disorder
* Use of any psychoactive drug and/or any type of antidepressant with in four weeks of the treatment phase of the study
* Predisposition to seizure or tic disorders or a personal history of a seizure disorder, family history of seizure disorders, or treatment with medication or therapies that increase the risk of seizures
* Significant history of or current clinical evidence of cardiovascular disease
* (Females)Pregnancy (urine pregnancy test), lactation or, if sexually active, unwillingness to use a medically acceptable form of contraception for the duration of the study
* Only one member of a household was allowed to participate in the study concurrently.

Answer: B