Varenicline for Nicotine Dependence Among Those With HIV/AIDS

Inclusion Criteria

• 18 years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average.
• Diagnosed with HIV infection and exhibiting viral load of 200 cells/mm3 within 6 months prior to enrollment.
• Able to use varenicline safely, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
• Residing in the geographic area for at least 7 months.
• Women of childbearing potential (based on medical history and physical exam) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain from sexual intercourse during the time they are taking study medication and for at least one month after the medication period ends.
• If current or past diagnosis of bipolar disorder (I, II, or NOS), eligible if:
• No psychotic features
• MADRS: total score 30 days).
• Positive urine drug screen (for cocaine and/or methamphetamines) at the Intake Session.
• Breath Alcohol Concentration (BrAC) assessment greater than or equal to 0.01 at the Intake Session.

Medication Exclusion Criteria

Current use or recent discontinuation (within last 14 days) of the following medications:

• Other smoking cessation medications (e.g. Zyban, Wellbutrin, Wellbutrin SR, Chantix)

a. Note: Once participants are found eligible for the study, they are instructed to only use the smoking cessation medication provided to them by the study staff. If a subject reports an isolated (non-daily) instance of using a non-study smoking cessation medication, the study physician and PI will evaluate the situation and determine if it is safe for the subject to continue participation.

• Anti-psychotic medications.

Medical Exclusion Criteria

• Women who are pregnant, planning a pregnancy within the next 7 months, or lactating.
• Current diagnosis of unstable and untreated major depression, as determined by self-report & MINI (eligible if stable for >30 days).
• Current or past diagnosis of psychotic disorder, as determined by self-report or MINI.
• Any suicide risk score on MINI, current suicidal ideation on Columbia scale, or self-reported lifetime suicide attempt.
• History of heart disease, stroke or MI, unstable angina, or tachycardia (if stable, requires Study Physician approval).
• Uncontrolled hypertension (SBP >160 or DBP >100).

a. Note: If a participant presents with blood pressure greater than 160/100 at sessions occurring on Week 0 (Pre-Quit) or at any other point during the treatment period, they will not be provided with/able to continue on medication unless the study physician grants approval.

• History of kidney or liver failure.
• Abnormal ECG (unless approved by study physician).
• Estimated creatinine clearance <50 mL/min, within 6 months prior to enrollment.
• AST and/or ALT results greater than 2 times the upper limit of normal, within 6 months prior to enrollment.
• Any impairment (physical, neurological, visual) preventing cognitive task performance.
• Previous allergic reaction to varenicline.

General Exclusion Criteria

• Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigator and/or Study Physician.
• Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.