A Phase 2 Randomized Controlled Trial to Compare Two Approaches in Achieving Smoking Abstinence among Patients in an Outpatient Clinic

Abstract

Background and Objectives: Having a disease and requiring medical attention present an excellent 'teachable moment' for smoking cessation interventions. However, nicotine is addictive and quitting is difficult, with a high rate of relapse, particularly among chronic smokers. Our previous smoking cessation projects in the community have revealed that many smokers who are reluctant to quit are interested in reducing the number of cigarettes they smoke per day. Therefore, smoking reduction may be an important alternative strategy for promoting smoking cessation. This Phase 2 randomized controlled trial of smokers who had medical follow-ups in an outpatient clinic compared the effectiveness of two approaches to smoking cessation: quitting immediately and cutting down to quit. Methods: A total of 100 subjects were randomized into two groups, 50 in the quit immediately group, who received an intervention on abruptly quitting, and 50 in the cut down to quit group, who received an intervention on gradual reduction. All subjects were followed up at 6 and 12 months via telephone, and their smoking status was assessed. The primary outcomes were self-reported 7-day point prevalence of abstinence at 6 and 12 months. Intention-to-treat analysis was employed. Results: On average, subjects had smoked 11.31 cigarettes per day over 37 years and 96% had mild nicotine dependence. At the 6-month follow-up, the self-reported quit rate of subjects in the quit immediately group was significantly higher than in the cut down to quit group (18.0% vs. 4.0%, p = 0.04). However, this difference was not significant at the 12-month follow-up (12.0% vs. 4.0%, p = 0.16). Conclusions: These data suggest that quitting immediately might be more effective than cutting down to quit in smokers who need to quit sooner, such as those with diseases requiring medical attention. Nevertheless, the effectiveness of the cut down to quit approach requires further testing.