Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers
Brief Summary: The objectives of this trial are:

Primary objectives:

1. To determine among HIV+ individuals whether varenicline or NRT is more effective at helping individuals remain abstinent from smoking tobacco.
2. To determine among HIV+ individuals whether varenicline or NRT has the lowest side-effect profile.
3. To determine if the HIV tailored Quit Smoking Counselling Intervention, plus smoking cessation drug therapy, improves smoking cessation rates compared to smoking cessation drug therapy alone with usual care.

Secondary objective:

1. To determine whether the use of varenicline/NRT is safe in HIV+ patients who exhibit depressive symptoms.

Hypothesis:

That varenicline will result in higher quit smoking rates and that NRT will result in a lower side effect profile. Further, the HIV tailored quit smoking intervention will result in higher rates of smoking cessation over and above the pharmacological treatment alone. And finally, varenicline will be safe to use for HIV + individuals who exhibit depressive symptoms.


Options:
A: Inclusion Criteria:

1. HIV positive
2. Adult (aged 18 or older)
3. Current smoker (more than 5 cigarettes per day)
4. Willing to set a date to quit smoking within the next 2-4 weeks
5. Currently on ART with an undetectable HIV viral load
6. Able to read/speak English or French
7. Able to provide written, informed consent as approved by the Ottawa Health Science Network Research Ethics Board and REBs at participating HIV clinic sites

Exclusion Criteria:

1. Contraindications to nicotine replacement therapy such as allergy to adhesive, serious cardiac arrhythmias (e.g., tachycardia), or vasospastic disease (e.g., Buerger's disease, Prinzmetal's variant angina)
2. Contraindications to varenicline such as hypersensitivity to varenicline or to any ingredient in the formulation or component of the container.
3. Reported previous severe intolerances to nausea or gastrointestinal symptoms.
4. Pregnant, lactating or planning to become pregnant during the study period or refuses a serum beta-HCG test.
5. Current severe renal impairment or currently taking Cimetidine
6. Previous or current seizure disorder and/or is taking anti-epileptic drugs
7. Psychosis and/or is taking anti-psychotic drugs
8. Diagnosed with severe major depressive episode requiring hospitalization within the past 12 months, previous psychiatric inpatient admission for any cause within the past 12 months, suicide attempt within the past 12 months active or current suicidal ideations as assessed by the BDI-II.
9. Current use of bupropion, varenicline or any nicotine replacement therapy.
10. Use of substances (e.g., crack cocaine) that would interfere with a participant's ability to adhere to the study schedule; determined by site coordinator's discretion.
B: Inclusion Criteria:

* Must be at least 18 years of age
* Be in good general health
* Must meet Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for nicotine dependence
* Be currently smoking \> 15 cigarettes/day, and have smoked cigarettes for the past 5 years
* Subjects must be motivated to quite smoking
* If female and of child bearing potential, agrees to use birth control and subject
* Subject must be able to understand and provide written informed consent.

Exclusion

Criteria:

* Please contact site for more information
C: Inclusion Criteria:

* Smokers aged 18 years or above and wanting to stop smoking
* Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
* Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
* The last attempt to stop smoking must be at least 3 months before entering the study

Exclusion Criteria:

* Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
* Individuals who have previously participated in clinical trials of varenicline
* Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days
D: Inclusion Criteria:

* Smokes a minimum of 10 cigarettes daily for at least 1 year prior to study entry
* Abstinence from alcohol and other non-nicotine drugs for between 1 and 12 months at time of study entry
* Meets criteria for alcohol dependence or abuse in the 12 months prior to study entry

Exclusion Criteria:

* History of seizures, head trauma and/or severe hepatic cirrhosis
* Current use of medications known to affect smoking behavior and/or cessation
* Use of tricyclic antidepressant medication and monoamine oxidase inhibitors
* Major depressive disorder within the month prior to study entry
* Eating disorder within the year prior to study entry
* History of bipolar or psychotic disorder
* Pregnant or breastfeeding
* Unstable serious medical disorder
* History of migraines
* Currently using smokeless tobacco, pipes, or cigars

Answer: A