Varenicline for Nicotine Dependence Among Those With HIV/AIDS

Inclusion Criteria

1. 18 years of age or older who self-report smoking at least 5 cigarettes (menthol andnon-menthol) per day, on average.

2. Diagnosed with HIV infection and exhibiting viral load of < 1000 copies/mL and CD4+counts of > 200 cells/mm3 within 6 months prior to enrollment.

3. Able to use varenicline safely, based on a medical evaluation including medicalhistory and physical examination, and psychiatric evaluation.

4. Residing in the geographic area for at least 7 months.

5. Women of childbearing potential (based on medical history and physical exam) mustconsent to use a medically accepted method of birth control (e.g., condoms andspermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tuballigation) or abstain from sexual intercourse during the time they are taking studymedication and for at least one month after the medication period ends.

6. If current or past diagnosis of bipolar disorder (I, II, or NOS), eligible if:

7. No psychotic features

8. MADRS: total score < 8 (past 4 weeks), suicidal item score < 1 (past 4 weeks)

9. Y-MRS: total score < 8 (past 4 weeks), irritability, speech content, disruptive,or aggressive behavior items score < 3 (past 4 weeks)

10. No psychiatric hospitalization or Emergency Room visits for psychiatric issues inthe past 6 months

11. No aggressive or violent acts or behavior in the past 6 months

12. Able to communicate fluently in English.

13. Capable of giving written informed consent, which includes compliance with therequirements and restrictions listed in the combined consent/HIPAA form.

Exclusion Criteria: Smoking Behavior

1. Current enrollment or plans to enroll in another smoking cessation program in the next 7 months.

2. Regular (daily) use of chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.

3. Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) orsmoking cessation treatments in the next 7 months.

4. Note: Once participants are found eligible for the study, they are told theyshould refrain from using any nicotine replacement therapy (NRT) for the durationof the study. If a subject reports an isolated (non-daily) instance of NRT useduring the study, they may be permitted to continue. Alcohol/Drug Exclusion Criteria

5. Current untreated and unstable diagnosis of substance abuse or dependence (eligible ifpast use and if receiving treatment and stable for >30 days).

6. Positive urine drug screen (for cocaine and/or methamphetamines) at the IntakeSession.

7. Breath Alcohol Concentration (BrAC) assessment greater than or equal to 0.01 at theIntake Session. Medication Exclusion Criteria Current use or recent discontinuation (within last 14 days) of the following medications:

8. Other smoking cessation medications (e.g. Zyban, Wellbutrin, Wellbutrin SR, Chantix) a. Note: Once participants are found eligible for the study, they are instructed toonly use the smoking cessation medication provided to them by the study staff. If asubject reports an isolated (non-daily) instance of using a non-study smokingcessation medication, the study physician and PI will evaluate the situation anddetermine if it is safe for the subject to continue participation.

9. Anti-psychotic medications. Medical Exclusion Criteria

10. Women who are pregnant, planning a pregnancy within the next 7 months, or lactating.

11. Current diagnosis of unstable and untreated major depression, as determined byself-report & MINI (eligible if stable for >30 days).

12. Current or past diagnosis of psychotic disorder, as determined by self-report or MINI.

13. Any suicide risk score on MINI, current suicidal ideation on Columbia scale, orself-reported lifetime suicide attempt.

14. History of heart disease, stroke or MI, unstable angina, or tachycardia (if stable,requires Study Physician approval).

15. Uncontrolled hypertension (SBP >160 or DBP >100). a. Note: If a participant presents with blood pressure greater than 160/100 atsessions occurring on Week 0 (Pre-Quit) or at any other point during the treatmentperiod, they will not be provided with/able to continue on medication unless the studyphysician grants approval.

16. History of kidney or liver failure.

17. Abnormal ECG (unless approved by study physician).

18. Estimated creatinine clearance <50 mL/min, within 6 months prior to enrollment.

19. AST and/or ALT results greater than 2 times the upper limit of normal, within 6 monthsprior to enrollment.

20. Any impairment (physical, neurological, visual) preventing cognitive task performance.

21. Previous allergic reaction to varenicline. General Exclusion Criteria

22. Any medical condition or concomitant medication that could compromise subject safetyor treatment, as determined by the Principal Investigator and/or Study Physician.

23. Inability to provide informed consent or complete any of the study tasks as determinedby the Principal Investigator and/or Study Physician.