Varenicline for Nicotine Dependence Among Those With HIV/AIDS
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline; Placebo; Smoking Cessation Counseling
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking cessation; Nicotine dependence; Varenicline; Chantix; HIV; AIDS

Summary:

      Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral
      therapy (HAART) has greatly improved survival rates and changed the leading causes of death,
      from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use
      among individuals with HIV/AIDS are very high and varenicline may be particularly efficacious
      for treating nicotine dependence among individuals with HIV/AIDS. Through this trial, 310
      smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation
      counseling or placebo plus 9 weeks of smoking cessation counseling. The investigators
      hypothesize that 1) varenicline and counseling will significantly increase end-of-treatment
      (week 12) and 24-week biochemically-confirmed abstinence, versus placebo and counseling; 2)
      quality of life will be rated higher in the varenicline and counseling group versus the
      placebo and counseling group, and there will be no significant differences between treatment
      arms in terms of the frequency of severe varenicline-related side effects; and 3) improved
      affect and reduced cognitive impairment will mediate the effect of varenicline therapy on
      quit rates.
    

Eligibility criteria:

        Inclusion Criteria

          1. 18 years of age or older who self-report smoking at least 5 cigarettes (menthol and
             non-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 medical
             history 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) 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.

          6. If current or past diagnosis of bipolar disorder (I, II, or NOS), eligible if:

               1. No psychotic features

               2. MADRS: total score < 8 (past 4 weeks), suicidal item score < 1 (past 4 weeks)

               3. Y-MRS: total score < 8 (past 4 weeks), irritability, speech content, disruptive,
                  or aggressive behavior items score < 3 (past 4 weeks)

               4. No psychiatric hospitalization or Emergency Room visits for psychiatric issues in
                  the past 6 months

               5. No aggressive or violent acts or behavior in the past 6 months

          7. Able to communicate fluently in English.

          8. Capable of giving written informed consent, which includes compliance with the
             requirements 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) or
             smoking cessation treatments in the next 7 months.

               1. Note: Once participants are found eligible for the study, they are told they
                  should refrain from using any nicotine replacement therapy (NRT) for the duration
                  of the study. If a subject reports an isolated (non-daily) instance of NRT use
                  during the study, they may be permitted to continue.

        Alcohol/Drug Exclusion Criteria

          1. Current untreated and unstable diagnosis of substance abuse or dependence (eligible if
             past use and if receiving treatment and stable for >30 days).

          2. Positive urine drug screen (for cocaine and/or methamphetamines) at the Intake
             Session.

          3. 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:

          1. 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.

          2. Anti-psychotic medications.

        Medical Exclusion Criteria

          1. Women who are pregnant, planning a pregnancy within the next 7 months, or lactating.

          2. Current diagnosis of unstable and untreated major depression, as determined by
             self-report & MINI (eligible if stable for >30 days).

          3. Current or past diagnosis of psychotic disorder, as determined by self-report or MINI.

          4. Any suicide risk score on MINI, current suicidal ideation on Columbia scale, or
             self-reported lifetime suicide attempt.

          5. History of heart disease, stroke or MI, unstable angina, or tachycardia (if stable,
             requires Study Physician approval).

          6. 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.

          7. History of kidney or liver failure.

          8. Abnormal ECG (unless approved by study physician).

          9. Estimated creatinine clearance <50 mL/min, within 6 months prior to enrollment.

         10. AST and/or ALT results greater than 2 times the upper limit of normal, within 6 months
             prior to enrollment.

         11. Any impairment (physical, neurological, visual) preventing cognitive task performance.

         12. Previous allergic reaction to varenicline.

        General Exclusion Criteria

          1. Any medical condition or concomitant medication that could compromise subject safety
             or treatment, as determined by the Principal Investigator and/or Study Physician.

          2. Inability to provide informed consent or complete any of the study tasks as determined
             by the Principal Investigator and/or Study Physician.