UW Quitting Using Intensive Treatment Study (QUITS)
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline; Nicotine patch; Placebo Patch; Placebo Pill
Intervention description: 0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.); 14 mg and 7 mg nicotine patches used. See arms for specific durations.; Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.; Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
Intervention MeSH terms: Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Double Blinded Placebo Controlled Factorial
Masking: Double (Participant, Care Provider)
Masking description: Active and placebo medications are identical in appearance. Medication labeling and the dispensing protocol are designed to prevent participants and care providers from knowing if the medication is active or placebo.
Enrollment: 1251.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Varenicline; Nicotine Patch; Quit Smoking; Tobacco; Cigarettes

Summary:

      This research will determine whether two highly promising modifications to varenicline
      treatment (i.e. use of a nicotine patch adjuvant and extended 24-week duration) produce
      superior smoking outcomes when they are either used together or alone. Despite their promise,
      the proposed modifications have never been experimentally evaluated relative to standard
      varenicline pharmacotherapy. Thus, this innovative research will produce novel evidence
      regarding how best to help smokers quit, and thereby address the leading cause of preventable
      mortality and morbidity related to cardiovascular and pulmonary diseases.
    

Eligibility criteria:

        Inclusion criteria:

        Participants must: plan to stay in the area for the next 12 months, ability to read and
        write in English, smoke on average ≥5 cigarettes per day over the last 6 months, be ≥18
        years old, desire to quit smoking but not be engaged currently in cessation treatment,
        report no use of pipe tobacco, cigars, snuff, e-cigarettes or chew in the last 30 days,
        have reliable phone access, willing and able to use both nicotine patch and varenicline,
        access to transportation to come to our clinic and, if female, not be pregnant and be using
        an acceptable birth control method/ method to prevent pregnancy. Smoking will be
        biochemically confirmed via a carbon monoxide (CO) breath test at the orientation session
        visit. Potential participants must have a CO test result of ≥5ppm for eligibility to
        participate.

        Exclusion criteria:

        Current treatment for schizophrenia or a psychotic disorder; suicidal ideation in the past
        12 months; history of suicidal attempts within the last 10 years; on dialysis or being told
        you have severe kidney disease; hospitalization for a stroke, heart attack, congestive
        heart failure or uncontrolled diabetes mellitus within the past year; history of seizure
        within the last year; currently taking Wellbutrin, Zyban, or Buproprion (Contrave is a
        weight-loss drug that has Wellbutrin in it) for reasons other than to quit smoking or
        taking to help quit smoking and not willing to stop for duration of the study; currently
        using any form of nicotine replacement (e.g., nicotine patch, nicotine gum, nicotine
        lozenge) or using Chantix or varenicline and not willing to stop for duration of the study;
        had a reaction to the nicotine patch that prevented them from continuing to use it; or
        currently participating in another smoking cessation study.

        Pregnancy:

        Even though we screen out participants who are pregnant, plan to become pregnant, nursing,
        or are unwilling to take steps to avoid pregnancy, there is a chance that a participant
        eligible at consent could become pregnant later. She would then be considered part of a
        vulnerable group. Given the longitudinal nature of the research, a participant who becomes
        pregnant after enrolling will be given the choice of whether to 1) continue in the study
        (for counseling and other assessments) and agree to immediately stop taking study meds for
        the remaining duration of the study and return any unused medications, OR 2) withdraw. No
        further medications will be given to this study participant while in the study.

        Incarcerated Individuals:

        Incarcerated individuals will not be enrolled in this study. However, given the
        longitudinal nature of the research, participants could be incarcerated for periods during
        their participation. If study staff learn that a participant is incarcerated at a time
        point before or at their Week 8 phone call, the participant will be withdrawn from the
        study. If study staff learn that a participant is incarcerated subsequent to Week 8, the
        participant will not be withdrawn unless that incarceration will take them beyond the study
        period. In that case, staff will not contact the participant while incarcerated and will
        not provide any treatment (counseling or medication) nor conduct any assessments during the
        period of incarceration. Services and assessments will be re-initiated if the participant
        is released at a later study time point.