Identifying Optimal Smoking Cessation Intervention Components (Cessation)
Condition: Smoking; Smoking Cessation; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Counseling before quit attempt; Minimal In-person counseling during quit attempt; Intensive in-person counseling during the quit attempt; Minimal phone counseling during the quit attempt; Intensive phone counseling during the quit attempt; Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Pre-Quit Nicotine Gum; Pre-Quit Nicotine Patch; Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
Intervention description: Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.; Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.); Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.; Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.; Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.; If randomized to this condition:
After the target quit day:
Patch:
IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.; If randomized to this condition:
After the target quit day:
Patch:
IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.; If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.; If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):
Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.; If randomized to both the Prequit Patch and Prequit Gum Conditions:
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 637.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Smoking; Smoking Cessation; Nicotine

Summary:

      The goal of this research is to identify the best smoking cessation intervention components
      to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This
      research examines the ability of different interventions, provided both prior to and after
      the quit attempt, to maximize the ability to initially quit and then stay quit. The
      investigators will be examining six different treatment interventions: pre-quit nicotine
      patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit
      phone counseling and duration of post-quit nicotine replacement therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older;

          -  Report smoking at least 5 cigarettes per day for the previous 6 months;

          -  Able to read and write English;

          -  Agree to attend visits, to respond to coaching calls, and to respond to Interactive
             Voice Response (IVR) phone prompts;

          -  Plans to remain in the intervention catchment area for at least 12 months;

          -  Currently interested in quitting smoking (defined as would like to try to quit in the
             next 30 days).

          -  All women of childbearing potential will be required to agree to use an acceptable
             method of birth control to prevent pregnancy during the study.

        Exclusion Criteria:

          -  Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is
             not exclusionary if the participant agrees to use only study medication for the
             duration of the study);

          -  Study candidate is pregnant, trying to get pregnant, or nursing.

          -  A history of psychosis or bipolar disorder

          -  A history of skin or allergic reactions while using a nicotine patch.

          -  Had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.