Evaluation of Treatments to Improve Smoking Cessation Medication Adherence
Condition: Smoking; Smoking Cessation; Adherence; Nicotine Dependence; Motivation
MeSH terms: Tobacco Use Disorder
Intervention: Short Term Combination Nicotine Replacement Therapy (patch + gum); Long Term Combination Nicotine Replacement Therapy (patch + gum); Intensive Maintenance Counseling; Cognitive Medication Adherence Counseling (CAM); Electronic Medication Monitoring Device (the Helping Hand) + Feedback; Automated Adherence Prompting Phone Calls
Intervention description: IF participant smokes >10 cigs/day AND is randomized to a 8 week condition: they will be asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants will also be asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.
IF participant smokes 5-10 cigs/day AND is randomized to the 8 week medication condition: they will be asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants will also be asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.; IF the participant smokes >10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants will also be asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.
IF the participant smokes 5-10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants will also be asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.; Participants randomized to this condition will receive eight 15-minute phone counseling sessions at Weeks 3, 4, 6, 8, 10, 14, 18 & 22. The counseling will encourage continued practice of coping skills, and avoidance of danger situations. Another emphasis will be the continued provision of social support as a means of enhancing motivation. Participants who have relapsed will receive counseling aimed at motivating and planning renewed quit attempts. Other aims are enhancing motivation, especially competence self-appraisals, providing intratreatment support, and encouraging pleasurable activities.; Participants randomized to this condition will be given a brief (10 minute) session of CAM treatment at both Visits 1 and 2. CAM will include information on NRT such as the following: NRT reduces withdrawal and urges; sustained use reduces the likelihood of relapse; willpower and medication make a good combination; NRT will help a lapsing smoker reachieve abstinence. The tailored counseling component of the CAM intervention is based on brief evaluation of the smoker's beliefs, concerns, and possible misconceptions about smoking cessation medications.; If randomized to this condition, the case manager will give patients a computer-generated feedback sheet showing the patient's medication self-administration since the last visit. The case manager will provide problem-solving counseling regarding barriers to medication use. This problem-solving counseling intervention will be given in brief in-person sessions (three in-person sessions for those in the 8 week medication condition and five in-person sessions for those in the 26 week medication condition). Medication monitoring counseling will also occur via phone (two 10-minute sessions for those in the 8 week medication condition and four 10-minute sessions for those in the 26 week medication condition).; Participants in this condition will receive fully automated prompts with messages designed to encourage participants to take their medication.
Adherence prompting calls will occur two times in the first week of the quit attempt, and then once a week in weeks 2, 3, 4, 5, and 7. Those in the 26-Week medication condition who are assigned to the active adherence prompting calls intervention, will receive one prompting call a week during Weeks 11, 15, 19 & 23.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 544.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Smoking; Smoking Cessation; Adherence; Nicotine; Motivation

Summary:

      Many smokers fail to take their smoking cessation medication as recommended. This research is
      designed to identify treatments that improve the use of cessation medications and to
      determine whether an increase in medication use results in increased cessation success. This
      research will also identify treatments that help people stay quit after a quit attempt and
      will pioneer more efficient research methods.
    

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.