Please select the eligibility criteria that correspond to the clinical trial below.
Title: 1/2-Multi-site Study: Varenicline Treatment of Alcohol Dependent Smokers
Brief Summary: The purpose of this study is to determine whether varenicline is effective in the treatment of alcohol dependence in smokers.


Options:
A: Inclusion Criteria:

* are 18 - 70 years of age and seeking treatment of alcohol drinking;
* meet DSM-IV TR Criteria for Alcohol Dependence
* report smoking 100 cigarettes or more in their lifetime and currently smoke at least twice weekly on average in the past 90 days and have a urinary cotinine level of \> 30ng/mL by semi-quantitative urinalysis or equivalent plasma cotinine level (\> 6 ng/mL);
* report heavy drinking on at least 2 days on average per week (i.e., ≥ 4 drinks on an occasion for women and ≥ 5 drinks for men) for the past 90 days and no more than 7 consecutive days of abstinence at intake.

Exclusion Criteria:

* exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation including:

  * any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin)
  * clinically significant, unstable cardiovascular disease/uncontrolled hypertension
  * hepatic or renal impairment
  * severe obstructive pulmonary disease
  * diabetes mellitus requiring insulin or certain oral medications (i.e., sulfonylureas) and an A1C hemoglobin test score of \> 7 for participants not prescribed these medications
  * baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg
* have a history of cancer (except treated basal cell or squamous cell carcinoma of the skin)
* have a history of serious hypersensitivity reactions or skin reactions to varenicline;
* exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders by history or psychological examination
* report current suicidal ideation (past 6 months) or lifetime hx of suicidal behavior assessed with the Columbia Suicide Severity Rating Scale 60; or risk for aggression using a cut-off of 15 or more on the Overt Aggression Scale - Modified Aggression Scale or 6 or more on the OAS-M Irritability Subscale 61.
* have used any psychotropic drug in the past month, except individuals who are on a stable dose of a Selective Serotonin Reuptake Inhibitor for at least two months or who report occasional use of prescription sleep aids that they are willing to discontinue;
* have a current DSM-IV diagnosis of drug dependence other than nicotine or alcohol
* are at risk for an alcohol withdrawal syndrome as evidenced by:

  * a history of seizures, delirium, or hallucinations during alcohol withdrawal
  * a Clinical Institute Withdrawal Assessment scale 62 score of \> 8,
  * report drinking to avoid withdrawal symptoms
  * have required medical treatment of alcohol withdrawal within the past 6 months
* have used another investigational drug within 30 days or have used medications to treat alcohol (e.g., naltrexone, topiramate, acamprosate, disulfiram) or nicotine use (e.g., clonidine, varenicline, bupropion, nicotine replacement) in the past 3 months or intend to use these medications;prior use of nicotine replacement in situations where smoking is not permitted (e.g., planes) without the intention to quit smoking is not exclusionary;
* intend to donate blood or blood products during the treatment phase of the study
* have a Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 39.99 or weight less than 45 kg;
* are a female of childbearing potential who is pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide).
B: Inclusion Criteria:

* Participant is a current smoker (≥ 10 cigarettes per day in the preceding\\ six months);
* Participant is willing to make a quit attempt in the 2-4 weeks after initial screening for eligibility;
* Participant is 18 years of age and older;
* Participant is willing to provide informed consent.

Exclusion Criteria:

* Participant is currently using or has used any intervention medications in the previous 6 months (i.e, Champix (varenicline); and/or Nicotine replacement therapy (patch, gum, inhaler, lozenge));
* Participant has contraindication(s) to any of the following smoking cessation medications:

  * Nicotine replacement therapy (allergic reaction to adhesive; serious cardiac arrhythmias (e.g., tachycardia); participant is during the immediate post-myocardial infarction period (i.e. incident has occurred within the last 10 days); severe or worsening angina pectoris; participant has had a recent cerebral vascular accident);
  * Varenicline (end-stage renal disease; use of cimetidine (by participants with severe renal impairment); previous allergic reaction to varenicline);
* Pregnant or breastfeeding women or those intending to become pregnant in the next year;
* Current or previous (in the last 3 months) substance abuse;
* Unable to provide informed consent due to unstable psychiatric symptoms (e.g., active, untreated psychosis or suicidality);
* Participant is unable to read and understand English or French;
* In order to prevent contamination across groups, only one person per household may participate.
C: Inclusion Criteria:

* Smoker of at least 10 cigarettes per day on average over the past 12 months
* Inpatient with an anticipation admission of at least one day
* Willingness to quit smoking
* Aged between 20 and 75 years
* A plan of discharge to go home
* Acute hospital admission with cardiovascular, cerebrovascular, peripheral vascular diseases or airways (asthma and/or Chronic Obstructive Pulmonary disease

Exclusion Criteria:

* Subject preference to use an alternative pharmacotherapy for smoking cessation
* Respiratory patient being considered for home oxygen
* Pregnancy
* Breast feeding
* Acute or pre-existing severe psychiatric illnesses
* Past history of psychosis or suicidal ideation
* Renal impairment with creatinine clearance \<30ml/min
D: Inclusion Criteria:

* Smokers seeking treatment
* Aged 18 and over
* Consenting to take part in the trial

Exclusion Criteria:

* Pregnant or breastfeeding
* End-stage renal disease
* Used varenicline in the past 6 months
* Unable to fill in questionnaires in English
* Current psychiatric illness
* Current serious illness including uncontrolled hypertension and recent cardiac event
* Sensitivity to varenicline currently enrolled in other research projects.

Answer: A