title: A randomized placebo-controlled clinical trial of 5 smoking cessation pharmacotherapies.
abstract: BACKGROUND
  Little direct evidence exists on the relative efficacies of different smoking cessation pharmacotherapies, yet such evidence is needed to make informed decisions about their clinical use.
  
  
  OBJECTIVE
  To assess the relative efficacies of 5 smoking cessation pharmacotherapy interventions using placebo-controlled, head-to-head comparisons.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled clinical trial.
  
  
  METHODS
  Two urban research sites.
  
  
  METHODS
  One thousand five hundred four adults who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. Participants were excluded if they reported using any form of tobacco other than cigarettes; current use of bupropion; having a current psychosis or schizophrenia diagnosis; or having medical contraindications for any of the study medications.
  
  
  METHODS
  Participants were randomized to 1 of 6 treatment conditions: nicotine lozenge, nicotine patch, sustained-release bupropion, nicotine patch plus nicotine lozenge, bupropion plus nicotine lozenge, or placebo. In addition, all participants received 6 individual counseling sessions.
  
  
  METHODS
  Biochemically confirmed 7-day point-prevalence abstinence assessed at 1 week after the quit date (postquit), end of treatment (8 weeks postquit), and 6 months postquit. Other outcomes were initial cessation, number of days to lapse, number of days to relapse, and latency to relapse after the first lapse.
  
  
  RESULTS
  All pharmacotherapies differed from placebo when examined without protection for multiple comparisons (odds ratios, 1.63-2.34). With such protection, only the nicotine patch plus nicotine lozenge (odds ratio, 2.34, P < .001) produced significantly higher abstinence rates at 6-month postquit than did placebo.
  
  
  CONCLUSIONS
  While the nicotine lozenge, bupropion, and bupropion plus lozenge produced effects that were comparable with those reported in previous research, the nicotine patch plus lozenge produced the greatest benefit relative to placebo for smoking cessation.
authors.affiliation: Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA. p@ctri.medicine.wisc.edu
authors.forename: Megan E
authors.initials: ME
authors.lastname: Piper
authors.forename: Stevens S
authors.initials: SS
authors.lastname: Smith
authors.forename: Tanya R
authors.initials: TR
authors.lastname: Schlam
authors.forename: Michael C
authors.initials: MC
authors.lastname: Fiore
authors.forename: Douglas E
authors.initials: DE
authors.lastname: Jorenby
authors.forename: David
authors.initials: D
authors.lastname: Fraser
authors.forename: Timothy B
authors.initials: TB
authors.lastname: Baker
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D016642:Bupropion / Q000008:administration & dosage / Q000627:therapeutic use*; D003376:Counseling; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos; D012008:Recurrence; D012907:Smoking / Q000188:drug therapy*; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D013607:Tablets / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D010919:Placebos; D013607:Tablets; D016642:Bupropion; D009538:Nicotine