Tobacco dependence counseling in a randomized multisite clinical trial.

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a "train-the-trainer" model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3±2.8 sessions (mean±SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and "meeting expectations" on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation.

Bupropion for the treatment of nicotine dependence in spit tobacco users: a pilot study.

Few pharmacological therapies have been shown to increase abstinence rates among spit tobacco (ST) users. Bupropion has been shown to be effective in increasing abstinence rates among smokers but has not been studied in ST users. Sixty-eight adult (aged > or = 18 years old) regular users of ST who were motivated to stop using ST were enrolled in a randomized, double-blind, placebo-controlled pilot study of bupropion sustained release (SR) or placebo for 12 weeks. The primary endpoint was 1-week, biochemically confirmed point-prevalence tobacco abstinence rate at the end of treatment (week 12). Nicotine withdrawal symptoms and weight change were assessed. At the end of 12 weeks of therapy, the point-prevalence tobacco abstinence rate was 44% in the bupropion group and 26% in the placebo group (p = 0.064). At 24 weeks following initiation of medication, the point-prevalence abstinence rate was 29% for both groups. After 7 weeks of medication, subjects on bupropion reported significantly less (p< or = 0.034) nicotine withdrawal than placebo. The mean weight change from baseline to end of treatment was +0.7 +/- 1.9 kg for bupropion and +4.4 +/- 2.4 kg for placebo (p = 0.03). The 6-month weight change for continuously abstinent subjects was 3.4 +/- 3.6 kg in the bupropion group and 6.2 +/- 5.0 kg in the placebo group (p = 0.49). Bupropion may increase abstinence rates in ST users and appears to attenuate weight gain during ST abstinence. Larger randomized, controlled trials of bupropion for ST users are needed.