Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke
Condition: Smoking; HIV
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Varenicline; Positively Smoke Free; Placebo; Standard of Care
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The single greatest health behavior change that could improve cardiovascular morbidity and
      associated mortality is to assist people living with HIV/AIDS who smoke to quit. The
      investigators will use a factorial design to evaluate the most promising behavioral and
      pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among
      people living with HIV/AIDS who smoke. Results of this study will provide crucial, real world
      evidence of the best way for healthcare providers to help smokers living with HIV/AIDS quit
      smoking.
    

Eligibility criteria:

        Study Inclusion Criteria:

          1. Confirmed chart diagnosis of a HIV and receiving HIV treatment at the participating
             HIV clinic.

          2. Age 18 years or older.

          3. Currently self-report smoking 10 cigarettes per day

          4. Motivation to quit within the next 6 months (score 5-8 on the Abrams and Briener
             Readiness to Quit Ladder);

          5. Does not meet criteria for current Diagnostic Statistical Manual (DSM) 5 moderate or
             severe alcohol use disorder or moderate or severe substance use disorder as
             established by the Mini Neuropsychiatric Interview (MINI) drug and alcohol sections
             (in the last 3 months)

          6. Able to read and speak English

          7. Willingness and ability to provide informed consent to participate.

        Study Exclusion Criteria:

        The exclusion criteria are designed to maximize safety by minimizing drug interactions or
        worsening pre-existing comorbid psychiatric or medical conditions:

          1. Current suicidal thoughts or ideation (past week); recent suicidal thoughts or
             ideation (past 6 months) or recent suicide attempt (past 6 months) as assessed by the
             Columbia-Suicide Severity Rating Scale (C-SSRS).

          2. Previous allergic reaction or hypersensitivity to Varenicline (by participant report
             ever in lifetime)

          3. Pregnant, nursing, or becoming pregnant during the study (pregnancy test).

          4. Current use of any medication that would interfere with the protocol in the opinion of
             Medically Accountable Physician including use of bupropion targeting nicotine
             dependence

          5. Moderate to severe renal impairment (< 30 mL/min)--As determined by a physician
             assessment, chart review or thru blood work

          6. Unstable cardiovascular disease (myocardial infarction within past year, uncontrolled
             arrhythmia, uncontrolled angina, uncontrolled congestive heart failure,
             electrocardiogram abnormality with QTC > 500 msec, cerebrovascular event within past
             year). (As determined by a physician assessment, chart review and/or EKG)

          7. Meets criteria for dementia by scoring below 10 on the Hopkins HIV Dementia Scale.
             This criterion is included to ensure the sample consists of participants who are
             cognitively able to engage in the study procedures

          8. Scores <5 ppm of expired carbon monoxide (CO) on the Smokelyzer

          9. The study physician believes that the individual is not medially stable enough to
             participate in the study. This exclusion will be based on a review of the individual's
             past medical history and current medical status.

         10. Recent use of Varenicline (by participant report in the past 3 months)