The development and implementation of effective smoking cessation programs remains an important public health priority. Data from the 1974 - 1987 National Health Interview Surveys show that between 1974 and 1987 the population ages 25 - 47 increased by 47%. One result was that the actual number of male and female smokers in this age range increased by 8 and 15% respectively. Most of the smokers in this age group have not yet experienced smoking- attributable diseases so that a substantial reduction in chronic disease might be achieved if smokers in this age group can be induced to quit. In this study we propose to (1) Evaluate the effectiveness of a pharmacologic intervention (transdermal nicotine TTS) combined with a self-help/minimal intervention (relapse prevention program) in achieving 12-month abstinence and (2) To study craving over the course of treatment and to confirm our previous finding that degree of craving is significantly associated with relapse. The 20th report of the Surgeon General on the addicting nature of cigarette smoking warrants our continued study of pharmacological interventions. Development of self-help strategies for smoking cessation is appropriate since they may be the prefer-red means by which smokers stop and can produce success rates approximating those of more formal programs, at lower cost and with greater access to relevant populations. 400 subjects will be randomized to one of two conditions: (1) transdermal TTS (nicotine) system + Self help behavioral intervention; (2) placebo system + Self help behavioral intervention. Follow-up of all participants will conducted at 12 weeks, 6 and 12 months to compare short- and long-term cessation and maintenance in the two groups. Allocation to group will be doubleblind. Excluded will be pregnant or lactating women, individuals with terminal illnesses, active peptic ulcer disease, recent myocardial infarction or unstable angina, Raynaud's disease or thromboangiitis obliterans, subjects who currently use nicotine gum, have a history of alcohol or substance abuse, have a history of skin allergies, psoriasis or eczema. In addition to self-report, expired air carbon monoxide and saliva cotinine levels will be determined. Assessments will be conducted at 12 weeks, 6 and 12 months post-randomization.
| Bailey, Steffani R; Fong, Dalea M; Bryson, Susan W et al. (2010) Perceived drug assignment and treatment outcome in smokers given nicotine patch therapy. J Subst Abuse Treat 39:150-6 |
| Killen, J D; Fortmann, S P (1997) Craving is associated with smoking relapse: findings from three prospective studies. Exp Clin Psychopharmacol 5:137-42 |
