title: Efficacy of a nicotine lozenge for smoking cessation.
abstract: BACKGROUND
  Since nicotine gum was introduced in the 1980s, nicotine replacement therapy has become the most widely used pharmacological smoking cessation treatment. Some smokers prefer acute oral forms, but many smokers reject chewing gum. We tested the safety and efficacy of a new nicotine polacrilex lozenge for smoking cessation.
  
  
  METHODS
  Double-blind, placebo-controlled, randomized clinical trial with parallel arms testing 2- and 4-mg nicotine lozenges. Smokers (n = 1818) were assigned to a lozenge dose on the basis of nicotine dependence, assessed by time to the first cigarette of the day. Low-dependence smokers were randomized to receive the 2-mg nicotine (n = 459) or placebo (n = 458) lozenge; high-dependence smokers, the 4-mg nicotine (n = 450) or placebo (n = 451) lozenge. We assessed abstinence at 6, 12, 24, and 52 weeks and analyzed craving and withdrawal symptoms.
  
  
  RESULTS
  Treatment with the nicotine lozenge resulted in significantly greater 28-day abstinence at 6 weeks, for the 2-mg (46.0% vs. 29.7%; odds ratio [OR], 2.10; 95% confidence interval [CI], 1.59-2.79; P<.001) and the 4-mg (48.7% vs. 20.8%; OR, 3.69; 95% CI, 2.74-4.96; P<.001) lozenges, compared with placebo. Significant treatment effects were maintained for a full year. Smokers who used more lozenges achieved significantly better treatment effects. Use of the active lozenge also resulted in reduced craving and withdrawal. Most adverse events were moderate and resembled those seen with nicotine gum.
  
  
  CONCLUSIONS
  The nicotine lozenge is a safe and effective new treatment for smoking cessation in low- and high-dependence smokers.
authors.affiliation: Pinney Associates, 201 N Craig St, Suite 320, Pittsburgh, PA 15213, USA. shiffman@pinneyassociates.com
authors.forename: Saul
authors.initials: S
authors.lastname: Shiffman
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Dresler
authors.forename: Peter
authors.initials: P
authors.lastname: Hajek
authors.forename: Simon J A
authors.initials: SJ
authors.lastname: Gilburt
authors.forename: Darren A
authors.initials: DA
authors.lastname: Targett
authors.forename: Kenneth R
authors.initials: KR
authors.lastname: Strahs
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D011109:Polymethacrylic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D011145:Polyvinyls / Q000008:administration & dosage / Q000627:therapeutic use*; D016540:Smoking Cessation; D013607:Tablets; D061485:Tobacco Use Cessation Devices
chemical_list: D011109:Polymethacrylic Acids; D011145:Polyvinyls; D013607:Tablets; D009538:Nicotine