INTRODUCTION: This study examined the efficacy and safety of selegiline transdermal system (STS) and brief repeated behavioral intervention (BRBI) for smoking cessation in heavy smokers. We hypothesized that the quit rate of subjects who received STS and BRBI would be significantly greater than that of those who received placebo patch and BRBI. METHODS: This was a double-blind, placebo-controlled parallel-group study in which 246 men and women were randomized to receive either STS (n = 121) or placebo patch (n =125) for 9 weeks. Recruitment targeted heavy smokers, defined as individuals with self-reported use of ≥15 cigarettes/day in the 30 days prior to enrollment, who had smoked cigarettes for the past 5 years, and had an expired CO level ≥9 ppm during screening. RESULTS: Although STS was well tolerated, the overall results indicated that STS with BRBI was not more effective than placebo plus BRBI for smoking cessation (p = .58). CONCLUSIONS: The results are discussed in relation to interventions for heavy smokers. Although 2 trials using oral selegiline both showed trends toward improved abstinence, these results indicate that STS with BRBI was not an effective aid for smoking cessation at the end of treatment (10 weeks), 14, or 26 weeks.
RCT Entities:
INTRODUCTION: This study examined the efficacy and safety of selegiline transdermal system (STS) and brief repeated behavioral intervention (BRBI) for smoking cessation in heavy smokers. We hypothesized that the quit rate of subjects who received STS and BRBI would be significantly greater than that of those who received placebo patch and BRBI. METHODS: This was a double-blind, placebo-controlled parallel-group study in which 246 men and women were randomized to receive either STS (n = 121) or placebo patch (n =125) for 9 weeks. Recruitment targeted heavy smokers, defined as individuals with self-reported use of ≥15 cigarettes/day in the 30 days prior to enrollment, who had smoked cigarettes for the past 5 years, and had an expired CO level ≥9 ppm during screening. RESULTS: Although STS was well tolerated, the overall results indicated that STS with BRBI was not more effective than placebo plus BRBI for smoking cessation (p = .58). CONCLUSIONS: The results are discussed in relation to interventions for heavy smokers. Although 2 trials using oral selegiline both showed trends toward improved abstinence, these results indicate that STS with BRBI was not an effective aid for smoking cessation at the end of treatment (10 weeks), 14, or 26 weeks.
Authors: J S Fowler; N D Volkow; G J Wang; N Pappas; J Logan; R MacGregor; D Alexoff; C Shea; D Schlyer; A P Wolf; D Warner; I Zezulkova; R Cilento Journal: Nature Date: 1996-02-22 Impact factor: 49.962
Authors: Joel D Killen; Stephen P Fortmann; Greer M Murphy; Chris Hayward; Dalea Fong; Kimberly Lowenthal; Susan W Bryson; Diana T Killen; Alan F Schatzberg Journal: Addiction Date: 2010-09 Impact factor: 6.526
Authors: J S Fowler; N D Volkow; G J Wang; N Pappas; J Logan; C Shea; D Alexoff; R R MacGregor; D J Schlyer; I Zezulkova; A P Wolf Journal: Proc Natl Acad Sci U S A Date: 1996-11-26 Impact factor: 11.205
Authors: John R Hughes; Josue P Keely; Ray S Niaura; Deborah J Ossip-Klein; Robyn L Richmond; Gary E Swan Journal: Nicotine Tob Res Date: 2003-02 Impact factor: 4.244
Authors: I Berlin; S Saïd; O Spreux-Varoquaux; J M Launay; R Olivares; V Millet; Y Lecrubier; A J Puech Journal: Clin Pharmacol Ther Date: 1995-10 Impact factor: 6.875
Authors: Jane E Sarginson; Joel D Killen; Laura C Lazzeroni; Stephen P Fortmann; Heather S Ryan; Niloufar Ameli; Alan F Schatzberg; Greer M Murphy Journal: Nicotine Tob Res Date: 2015-01-08 Impact factor: 4.244