title: Over-the-counter nicotine patch therapy for smoking cessation: results from randomized, double-blind, placebo-controlled, and open label trials.
abstract: OBJECTIVE
  The purpose of this study was to determine the efficacy and safety of the nicotine patch for smoking cessation in an over-the-counter environment. The years of study were 1994 to 1995.
  
  
  METHODS
  Parallel 6-week trials were conducted: a placebo-controlled trial of no-cost 22-mg, 24-hour nicotine patch therapy and an open label trial of the same therapy with patches purchased by subjects. Participants (n = 958) were 18 years or older, had smoked at least 15 cigarettes daily for at least 6 months, and were enrolled at 3 study sites. The main outcome measure was self-reported smoking abstinence confirmed by expired carbon monoxide measurements.
  
  
  RESULTS
  Smoking cessation rates in the placebo-controlled trial were 16.8% and 9.6% at week 6 and 8.7% and 4.3% at week 24 for the active patch and placebo groups, respectively. Smoking cessation rates in the open label-pay trial were 19.0% and 10.8% at weeks 6 and 24, respectively. A slight increase in adverse cardiovascular events was noted only in the open label-pay group in comparison with the placebo group.
  
  
  CONCLUSIONS
  In an over-the-counter environment, the 22-mg, 24-hour nicotine patch is effective and safe for smoking cessation treatment.
authors.affiliation: Mayo Clinic, Rochester, MN 55905, USA. hays.taylor@mayo.edu
authors.forename: J T
authors.initials: JT
authors.lastname: Hays
authors.forename: I T
authors.initials: IT
authors.lastname: Croghan
authors.forename: D R
authors.initials: DR
authors.lastname: Schroeder
authors.forename: K P
authors.initials: KP
authors.lastname: Offord
authors.forename: R D
authors.initials: RD
authors.lastname: Hurt
authors.forename: T D
authors.initials: TD
authors.lastname: Wolter
authors.forename: M A
authors.initials: MA
authors.lastname: Nides
authors.forename: M
authors.initials: M
authors.lastname: Davidson
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D002248:Carbon Monoxide / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage / Q000627:therapeutic use*; D004366:Nonprescription Drugs / Q000008:administration & dosage / Q000627:therapeutic use*; D012107:Research Design; D016540:Smoking Cessation / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D004366:Nonprescription Drugs; D009538:Nicotine; D002248:Carbon Monoxide