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October 9, 1995

Effectiveness of the 4-mg Dose of Nicotine Polacrilex for the Initial Treatment of High-Dependent Smokers

Author Affiliations

From the Palo Alto (Calif) Center for Pulmonary Disease Prevention and the Division of Pulmonary and Critical Care Medicine, Stanford (Calif) University School of Medicine.

Arch Intern Med. 1995;155(18):1973-1980. doi:10.1001/archinte.1995.00430180077009

Purpose:  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.

Subjects and Methods:  Ninety high-dependent (Fagerström Tolerance Questionnaire score ≥ 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 ≥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 cotinine 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 no 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.(Arch Intern Med. 1995;155:1973-1980)