title: Effectiveness of the 4-mg dose of nicotine polacrilex for the initial treatment of high-dependent smokers.
abstract: OBJECTIVE
  To determine the effectiveness of the 4-mg and 2-mg dosages of nicotine polacrilex vs placebo through the first 6 weeks of treatment (during which 75% of relapse occurs when there is no treatment) in assisting high-dependent smokers to stop smoking when instructed to use a fixed number (12 pieces) of medication daily.
  
  
  METHODS
  Ninety high-dependent (Fagerström Tolerance Questionnaire score > or = 7 plus baseline carbon monoxide level > 15 ppm) healthy male and female smokers, highly motivated to quit smoking, were enrolled in a 6-week, randomized, double-blind, placebo-controlled trial in which they were instructed to use 12 pieces per day of their assigned dosage formulation: 4 mg, 2 mg, or 0.5 mg (placebo) of nicotine polacrilex. The behavioral intervention did not depend on providing any special psychological training, skills, or services but rather employed a standard medical practice model that could easily be implemented by any primary care physician.
  
  
  RESULTS
  Sustained abstinence from weeks 2 through 6, determined at each visit by absolutely no cigarette use plus a carbon monoxide level of 8 ppm or lower was 59% (4-mg group), 30% (2-mg group), and 39% (placebo group) (P < .02). For the 55 of the 90 smokers who met the originally planned definition of high dependence (Fagerström Tolerance Questionnaire score > or = 7 plus baseline smoking serum cotinine level > 250 ng/mL plus baseline carbon monoxide level > 15 ppm), results were 63% (4-mg group), 25% (2-mg group), and 25% (placebo group) (P < .02). In addition, the 4-mg dose produced statistically significantly higher abstinence rates in compliant subjects (P < .02) and also in subjects with high baseline serum continine levels who were compliant (P < .01) than did either the 2-mg dose or placebo.
  
  
  CONCLUSIONS
  It appears that the 4-mg dose of nicotine polacrilex is the drug and dose of choice for the initial phase of tobacco dependence treatment in high-dependent smokers; the 2-mg dose of nicotine polacrilex is not better than placebo during the first 6 weeks of treatment for high-dependent cigarette smokers, and thus should not be used for these patients during the initial treatment phase.
authors.affiliation: Palo Alto (Calif) Center for Pulmonary Disease Prevention, USA.
authors.forename: D P
authors.initials: DP
authors.lastname: Sachs
mesh_terms: D000328:Adult; D003376:Counseling; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010349:Patient Compliance; D011109:Polymethacrylic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D011145:Polyvinyls / Q000008:administration & dosage / Q000627:therapeutic use*; D011320:Primary Health Care; D012907:Smoking / Q000188:drug therapy* / Q000628:therapy; D016019:Survival Analysis; D061485:Tobacco Use Cessation Devices; D016896:Treatment Outcome
chemical_list: D011109:Polymethacrylic Acids; D011145:Polyvinyls; D009538:Nicotine