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:

* Self-identified African American
* Smokes ≥ 1 cigarette per day (cpd)
* Smoke on ≥ 25 days of the past 30 days
* Functioning telephone
* Interested in quitting smoking
* Interested in taking 3 months of varenicline
* Willing to complete all study visits

Exclusion Criteria:

* Renal impairment
* Evidence or history of clinically significant allergic reactions to varenicline
* A cardiovascular event in the past month
* History of alcohol or drug dependence in the past year
* Major depressive disorder in the last year requiring treatment
* History of panic disorder, psychosis, bipolar disorder, or eating disorders
* Use of tobacco products other than cigarettes in past 30 days
* Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
* Pregnant, contemplating getting pregnant, or breastfeeding
* Plans to move from Kansas City during the treatment and follow-up phase
* Another household member enrolled in the study
* Evidence of current severe major depressive disorder or suicidal ideation
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: Exclusion Criteria:

* Pregnant or nursing women, or women of child-bearing potential who are not using an adequate method of contraception
* Psychiatric illnesses requiring psychotropic medications (i.e., psychosis, major depression, mania), or the presence of suicidality or homocidality
* Current use of nicotine replacement therapies (i.e., nicotine patch, gum, or lozenges, nasal spray, or inhaler), bupropion (Zyban, Wellbutrin), or marijuana or current participation in another smoking cessation treatment
* Presence of unstable medical conditions (i.e., cardiac, hepatic, renal disease, diabetes mellitus) that would make a trial of bupropion SR hazardous
* Have taken monoamine oxidase inhibitors or metoprolol succinate within the past six weeks
* History of anorexia nervosa or bulimia
* Previous hypersensitivity to bupropion
* History of alcohol or other drug dependence in the past one year
* History of seizure disorder of any etiology (i.e., brain tumor, traumatic brain injury, substance-induced seizures, etc.)
* Any finding that in the view of the principal investigator would compromise the subject's ability to fulfill the protocol visit schedule and visit requirements or put the subject at risk
* Sharing home or work environment with current or past participant
* No couples or participants who see each other every day
D: Inclusion Criteria:

* Currently a patient in the Omaha VA Medical Center, Substance Abuse Treatment Center (SATC) or at Catholic Charities Campus for Hope.
* Have a diagnosis of alcohol abuse or alcohol dependence.
* Smoke 20 or more cigarettes/day (may also smoke pipes/cigars).
* Be interested in quitting smoking.
* Provide name, addresses, and phone numbers of at least two individuals who can provide information on their alcohol, nicotine, and other drug use during the follow-up period.
* If female, patient must a) be of non-childbearing potential, b) have a negative pregnancy test, c) sign a document stating they do not plan on becoming pregnant during the study.
* Agree to sign informed consent.
* Able to read and understand study-related forms and procedures.

Exclusion Criteria:

* Advanced cardiac, pulmonary, renal, or liver disease.
* History of seizures.
* History of brain tumor or significant head trauma.
* History of bulimia or anorexia nervosa.
* Current major depressive disorder or past history of panic disorders, schizophrenia, or bipolar affective disorder.
* Using psychoactive drugs.
* Receiving treatment with medications that lower seizure thresholds.
* Use of an investigational drug in any study in the past four weeks.
* Currently using any asthma medication.
* Used time-released bupropion in the past 12 months.
* Currently using any other treatments to stop smoking.

Answer: B