Are higher doses of nicotine replacement more effective for smoking cessation?

John R. Hughes, George R. Lesmes, Dorothy K. Hatsukami, Robyn L. Richmond, Edward Lichtenstein, Douglas E. Jorenby, Joseph O. Broughton, Stephen P. Fortmann, Scott Leischow, James P. McKenna, Stephen I. Rennard, William C. Wadland, Scott A. Heatley

Research output: Contribution to journalArticlepeer-review

134 Scopus citations


This study determined whether higher dose nicotine patches are more efficacious than lower dose patches among heavy smokers. A randomized double-blind study compared 0, 21, 35, and 42 ing/day of a 24-h patch in 1039 smokers (≥30 cigarettes/day) at 12 clinical sites in the USA and one in Australia. Daily patches were used for 6 weeks followed by tapering over the next 10 weeks. Weekly group therapy occurred. Biochemically validated self-reported quit rates at 6, 12, 26, and 52 weeks post-cessation were measured. Quit rates were dose-related at all follow-ups (p < 0.01). Continuous, biochemically verified abstinence rates for the 0, 21, 35, and 42 mg doses at the end of treatment (12 weeks) were 16, 24, 30, and 39%. At 6 months, the rates were 13, 20, 20, and 26%. Among the 11 sites with 12 month follow-up (n = 879), the quit rates were 7, 13, 9, and 19%. In post-hoc tests, none of the active doses were significantly different from each other at any follow-up. The rates of dropouts due to adverse events for 0, 21, 35, and 42 mg were 3, 1, 3, and 6% (p = n.s.). Our results are similar to most prior smaller studies; i.e., in heavy smokers higher doses increase quit rates slightly. Longer durations of treatment may be necessary to show greater advantages from higher doses.

Original languageEnglish (US)
Pages (from-to)169-174
Number of pages6
JournalNicotine and Tobacco Research
Issue number2
StatePublished - Jun 1999

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health


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