Varenicline Light Smoking Pilot
Condition: Smoking Cessation; Smoking Behaviors; Smoking
Intervention: Varenicline; Placebo oral tablet
Intervention description: Chantix; Placebo
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2-arm randomized, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this study is to assess varenicline vs. placebo for its effect on decreasing cue
      reactivity in light and intermittent smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years or above

          2. Daily smoker using 10 or less cigarettes per day but a minimum of at least 1
             cigarettes per week or 4 cigs/month.

          3. Must be able to make it through a 24-hour period without nicotine withdrawal symptoms
             (specifically does not have new onset of irritability, headaches, insomnia, or intense
             cravings).

          4. Willing to quit smoking in the next 30 days

          5. Is able to provide written informed consent (in English) to participate in the study
             and is able to read/understand the procedures and study requirements.

          6. Is willing to voluntarily sign and date an informed consent form that is approved by
             an institutional review board before the conduct of any study procedure.

          7. If female and of childbearing potential, is willing to use medically acceptable
             contraceptive measures for the duration of the study. Acceptable methods of
             contraception include (1) surgical sterilization (such as tubal ligation or
             hysterectomy, (2) approved hormonal contraceptives (such as birth control pills,
             patches, implants or injections), (3) barrier methods (such as condom or diaphragm)
             used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures
             such as rhythm method or Plan B™, sold for emergency use after unprotected sex, are
             not acceptable methods for routine use.

          8. Have access to a cell phone that can send and receive SMS text messages.

        Exclusion Criteria:

          1. Use of a smoking cessation medication (e.g. nicotine replacement, varenicline,
             bupropion) in last 30 days.

          2. Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless
             tobacco) in the last 30 days

          3. Answer > 0 on suicidality question of Patient Health Questionnaire (PHQ-9) Depression
             Scale

          4. Active alcohol use disorder or hazardous drinking. This will be screened with the
             AUDIT-C, and positive scores (4 or greater for men and 3 or greater for women)54,55
             will result in study clinician assessment and discretion.

          5. Use of illicit drugs in the last month (marijuana, cocaine, opiates, benzodiazepines,
             and/or methamphetamine)

          6. Severe symptomatic depression and or anxiety (study medical provider discretion)

          7. Diagnosis of bipolar disorder, schizophrenia, PTSD and or adult ADHD (study medical
             provider discretion)

          8. Chronic medical illness including diabetes with the use of insulin, Hemoglobin A1c > 7
             (study medical provider discretion), heart disease diagnosed by angiogram, or COPD
             diagnosed by pulmonary function testing and requiring an oxygen supply

          9. Specific medications (Appendix 1)

         10. Abnormal finding on physical exam (study medical provider discretion)

         11. Positive Urine Pregnancy Test (women of child bearing potential only; QuickVue Urine
             Pregnancy)56

         12. Positive Urine Toxicology-5 Screen (methamphetamine, cocaine, opiates,
             benzodiazepines, THC)

         13. Unstable hypertension (Blood pressure > 160/100)

         14. Renal failure with active or pending hemodialysis