A Comparative Effectiveness RCT of Optimized Cessation Treatments
Condition: Smoking Cessation
Intervention: Nicotine patch; in-person counseling and quitline counseling; Preparation Nicotine Mini-Lozenges; Combination NRT (nicotine patch + nicotine mini-lozenges); Intensive In-Person Cessation Counseling; Extended Maintenance Counseling Calls; Automated Adherence Calls
Intervention description: 8 weeks of nicotine patch; a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website; Nicotine lozenge prior to attempting to quit smoking; 26 weeks of combination NRT as part of a quit smoking attempt; three 20-min In-person Cessation Counseling sessions; 8 Maintenance-phase smoking cessation counseling sessions; 11 brief, automated calls reminding them to use their medications properly
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 623.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: smoking; cessation; tobacco

Summary:

      This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit smoking
      will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2)
      Abstinence-Optimized Cessation Treatment (AOCT). The components for the optimized treatment
      have strong theoretical and empirical support from the investigators previous screening
      studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age >=18 years

          -  smoking >4 cigarettes/day for the previous 6 months

          -  able to read, write, and speak English

          -  have reliable phone access and agree to respond to Interactive Voice Response (IVR)
             phone prompts

          -  and if currently using NRT, agreeing to use only study medication for the duration of
             the study

          -  we will not exclude participants based on their prior use of cessation medication or
             if they use multiple tobacco products in order to enhance real-world generalization
             (these will be statistically controlled in analyses)

          -  not currently attempting to quit smoking

          -  not intending to quit smoking (defined as no plans to quit in the next month)

          -  and planning to remain in the intervention catchment area for at least 12 months.

        Exclusion Criteria:

          -  currently taking bupropion or varenicline

          -  medical contraindications to using NRT including hospitalized (for at least one night)
             for a stroke, heart attack, congestive heart failure or diabetes in the last 30 days

          -  diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder
             in the last 10 years

          -  and, if the participant is a woman of childbearing potential, being pregnant or
             intending to becoming pregnant or unwillingness to use an approved method of birth
             control during treatment.