title: A randomized, controlled trial to assess the efficacy and safety of a transdermal delivery system of nicotine/mecamylamine in cigarette smokers.
abstract: OBJECTIVE
  To determine the efficacy and safety of nicotine transdermal therapy co-administered with the nicotine antagonist, mecamylamine, compared to a nicotine transdermal patch alone (21 mg nicotine + 6 mg mecamylamine, 21 mg nicotine + 3 mg mecamylamine, and 21 mg nicotine + 0 mg mecamylamine).
  
  
  METHODS
  Multi-center (n = 4), double-blind, randomized, parallel group, repeat-dose study.
  
  
  METHODS
  Clinical laboratory.
  
  
  METHODS
  A total of 540 subjects were enrolled into the study-135 from each of four sites; 180 patients in each of three treatment arms.
  
  
  METHODS
  Treatment was administered for the first 6 weeks of the 8-week study. Patients were instructed to continue smoking for the first 2 weeks of treatment.
  
  
  METHODS
  The primary efficacy parameter was 4-week continuous abstinence after the quit date, confirmed with an expired carbon monoxide of < 10 parts per million.
  
  
  RESULTS
  Analysis of the 4-week continuous abstinence for the intent-to-treat population showed overall rates of 29% (nicotine + 6 mg mecamylamine), 29% (nicotine + 3 mg mecamylamine) and 23% (nicotine only) using the slip definition which allows smoking in the first 2 weeks after the quit date. Statistical analyses revealed no significant treatment differences. Analyses using the strict definition (no smoking after the quit date) yielded similar non-significant group differences (29%, 27%, 26%).
  
  
  CONCLUSIONS
  If adding mecamylamine to nicotine replacement therapy (NRT) improves the chances of success at stopping smoking, the results of this study suggest that the effect is very small.
authors.affiliation: Department of Public and Community Health, College of Health and Human Performance, University of Maryland, College Park MD 20742, USA. eglover1@umd.edu
authors.forename: Elbert D
authors.initials: ED
authors.lastname: Glover
authors.forename: Molly T
authors.initials: MT
authors.lastname: Laflin
authors.forename: Kory J
authors.initials: KJ
authors.lastname: Schuh
authors.forename: Leslie M
authors.initials: LM
authors.lastname: Schuh
authors.forename: Mitch
authors.initials: M
authors.lastname: Nides
authors.forename: Arden G
authors.initials: AG
authors.lastname: Christen
authors.forename: Penny N
authors.initials: PN
authors.lastname: Glover
authors.forename: Julia V
authors.initials: JV
authors.lastname: Strnad
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004333:Drug Administration Routes; D004342:Drug Hypersensitivity / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008464:Mecamylamine / Q000008:administration & dosage*; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage*; D018733:Nicotinic Antagonists / Q000008:administration & dosage*; D012449:Safety / Q000592:standards; D016540:Smoking Cessation / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D018733:Nicotinic Antagonists; D008464:Mecamylamine; D009538:Nicotine