Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of the Efficacy and Safety of Varenicline Versus Placebo for Smoking Cessation Among HIV-infected Patients. A Randomized Double Blind Controlled Trial
Brief Summary: Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo.


Options:
A: Inclusion Criteria:

1. Age 18 and older
2. Willingness and ability to give written consent
3. Smoking 20 cigarettes per day for at least 1 year
4. At least one prior attempt to stop smoking
5. Baseline expired carbon-monoxide level of at least 10 ppm
6. Weigh at least 100 lbs.
7. English speaking
8. One person per household

Exclusion Criteria:

1. Pregnant or nursing women or women who do not use a reliable form of birth control
2. Unstable cardiac disease
3. History of dermatoses
4. Current alcohol dependence
5. Current use of opiates
6. A urine drug screen that is positive for opiates
7. Serious current neurologic, psychiatric or medical illness
8. Chronic pain conditions necessitating opioid treatment
9. Evidence of significant hepatocellular injury as evidence by SGOT or SGPT \>3 x normal or elevated bilirubin
10. Current use of smokeless tobacco, pipes, cigars, nicotine gum or nicotine patch
11. Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component
B: Inclusion Criteria:

* Competent and mature
* Have diagnosed COPD \[spirometry verified and evaluated by pulmonary specialist\]
* Current daily smoker \[Minimum 1 cigarette daily\]
* Have smoked minimum 20 pack years (1 pack year = 20 cigarettes daily in 1 year)
* Want to or try to stop smoking
* Do not mind taking varenicline or NRT during the trial
* Are willing to give blood and urine samples according to the protocol

Exclusion Criteria:

* Previously included in the trial
* Hospitalized with COPD-exacerbation within the last 24 months
* Are associated with hospital outpatient clinic for COPD disease treatment
* Have FEV1\<50%.
* Pregnancy/breastfeeding
* Life expectancy less than 1 year
* Severe linguistic problems or inability to give informed consent
* Severe mental illness that is not controlled with medication
* Active alcohol or substance abuse
* Active cancer disease\* \*The person can participate if he or she has had a cancer disease that is now referred to as curative/radically treated. Basal cell carcinoma of the skin does not count as an exclusion criterion.
C: Inclusion Criteria:

* HIV-infected patients
* adults
* regular smokers (at least 10 cigarettes a day during the last year)
* motivated to stop smoking
* followed in one of the participating clinical ward,
* signed written inform consent

Exclusion Criteria:

* current co-dependency to another psychoactive substance
* ongoing depressive episode
* history of suicidal attempt
* ongoing treatment by interferon
* treatment by efavirenz for less than three months or not tolerated
* previous use of varenicline
* ongoing treatment by bupropion-SR or nicotinic substitute
* ongoing pregnancy
* ongoing breastfeeding
* hypersensitivity to varenicline or to one of its excipients
* drivers, air traffic controller
D: Inclusion Criteria:

* Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
* Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) \>10 ppm at screening.
* For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.

Exclusion Criteria:

* Subjects with a past or current diagnosis of one of the following disorders:

  a. Psychotic Disorders:
* Schizophreniform
* Delusional Disorder
* Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)

Answer: C