UW Withdraw From Tobacco Study
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)
Intervention description: Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 232.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      It is of considerable scientific and clinical importance to assess tobacco withdrawal
      accurately since withdrawal severity is highly determinant of smoking cessation success. In
      addition, smoking cessation pharmacotherapy produces its effects on smoking abstinence by
      suppressing such symptoms. However, in order to ensure that a measure of tobacco withdrawal
      is sensitive to severe withdrawal, it is essential to examine a period of unmedicated
      abstinence. The current study aims to validate, and possibly enhance, a revised Wisconsin
      Smoking Withdrawal Scale long and brief version for use in research and clinical settings.

      Two hundred adults who smoke cigarettes daily and report a desire to quit smoking will be
      enrolled. This is a treatment-delay, one-group clinical trial that is intended to enhance the
      assessment of tobacco withdrawal amongst participants who try to quit smoking with delayed
      use of cessation medication. Participants will not receive any pharmacotherapy during the
      first 1 week of their quit attempt and will initiate 8 weeks of combination nicotine
      replacement therapy (C-NRT; nicotine patch + nicotine mini-lozenge) starting 1 week past the
      target quit day (TQD). Participants will receive 4 counseling sessions as well (1 pre-quit, 3
      post-quit). Participants will complete 4 weeks of ecological momentary assessment (EMA)
      smartphone surveys including a 2-week baseline (starting TQD-14) and 2-week post-TQD (1-week
      un-medicated, 1-week using C-NRT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoke ≥5 cigarettes per day for past year

          -  ≥21 years old

          -  Able to read and write English

          -  Desire to quit smoking

          -  Not currently engaged in cessation treatment

          -  Eligible to use combination nicotine replacement therapy

          -  Willing and able to attend study visits

          -  Have reliable smartphone access

          -  Not currently pregnant, trying to get pregnant, or breastfeeding

          -  Willing to respond to ecological momentary assessment prompts and other study
             activities

          -  Baseline breath carbon monoxide (CO) ≥5ppm

        Exclusion Criteria:

          -  Used pipe tobacco, cigars, snuff, or chew more than twice in the past week

          -  Used e-cigarette, vaping, or any other electronic nicotine delivery product more than
             twice in the past week

          -  Unwilling to try to abstain from all non-medicinal nicotine use (including
             e-cigarettes) for the duration of the Cessation Phase (other than nicotine replacement
             therapy provided by the study)

          -  Currently taking varenicline or bupropion

          -  Allergy to adhesive tape

          -  Previous reaction to the nicotine patch or mini-lozenge that prevented them from
             continuing to use it

          -  Unwilling to use study approved methods of birth control while taking study medication
             and for 1 month after discontinuing study medication [only for women of child-bearing
             potential]

          -  Hospitalized for a stroke, heart attack, congestive heart failure, ulcers, or diabetes
             within the last year

          -  History of seizure within the last year

          -  Diagnosis of and/or treatment for schizophrenia, other psychotic disorders, or bipolar
             disorder within the last 5 years

          -  End-stage renal disease

          -  Suicide attempt or suicidal ideation within the last 12 months

          -  Severe hypertension > 180/100 mmHg