Gradual vs. Abrupt Cessation Treatment for Smoking
Condition: Smoking Cessation
Intervention: Reduction Phone Counseling; Abrupt Phone Counseling; Minimal Abrupt Phone Counseling; Pre-Quit Nicotine Lozenges; Post-Quit Nicotine Lozenges
Intervention description: Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date. This includes 5 counseling calls: 3 calls focused on reduction prior to the quit date, 1 call two days prior to the quit date to discuss common strategies for preparing to quit, and 1 call two days after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges during reduction and after the quit date.; Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date. This includes 5 counseling calls: 1 to set a quit date, 1 two days prior to the quit date to discuss common strategies for preparing to quit, and 3 after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges after the quit date.; Minimal counseling to mimic intervention at a primary care office. This includes 2 counseling calls: 1 to set a quit date and 1 two days after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges after the quit date.; 2 mg lozenges for participants usually smoke their first cigarette more than 30 minutes after awaking.
4 mg lozenge for participants who usually smoke their first cigarette less than 30 minutes after awaking.
Replace each forgone cigarette during reduction with one lozenge. Use additional lozenges to combat cravings to smoke.; 2 mg lozenges for participants usually smoke their first cigarette more than 30 minutes after awaking.
4 mg lozenge for participants who usually smoke their first cigarette less than 30 minutes after awaking.
Replace each forgone cigarette while abstinent with one lozenge. Use additional lozenges to combat cravings to smoke.
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 750.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking Cessation; Tobacco

Summary:

      This study tests whether stopping smoking by gradually cutting down first is more or less
      successful than stopping abruptly. We hypothesize that stopping by gradually cutting down
      first will produce more abstinence than stopping abruptly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Interested in quitting gradually

          -  At least 18 years old

          -  Daily cigarette smoker

          -  Smoke at least 15 cigarettes per day (CPD)

          -  No change greater than 20% in CPD in the last month

          -  Interested in quitting in next 30 days

          -  Must agree to not use non-cigarette tobacco during study

          -  No use of smoking cessation medication in last month

          -  Have phone with voice mail

          -  Willing to use nicotine lozenge

          -  No other person in household in study

          -  Fluent/literate in English

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Currently using medication for depression or asthma

          -  Heart disease requiring medication

          -  Heart attack in last month

          -  Irregular heartbeat

          -  High blood pressure not controlled by medication

          -  Stomach ulcers

          -  Diabetes