title: Are higher doses of nicotine replacement more effective for smoking cessation?
abstract: 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 mg/day of a 24-h patch in 1039 smokers (> or = 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.
authors.affiliation: Department of Psychiatry, University of Vermont, Burlington 05401-1419, USA. john.hughes@uvm.edu
authors.forename: J R
authors.initials: JR
authors.lastname: Hughes
authors.forename: G R
authors.initials: GR
authors.lastname: Lesmes
authors.forename: D K
authors.initials: DK
authors.lastname: Hatsukami
authors.forename: R L
authors.initials: RL
authors.lastname: Richmond
authors.forename: E
authors.initials: E
authors.lastname: Lichtenstein
authors.forename: D E
authors.initials: DE
authors.lastname: Jorenby
authors.forename: J O
authors.initials: JO
authors.lastname: Broughton
authors.forename: S P
authors.initials: SP
authors.lastname: Fortmann
authors.forename: S J
authors.initials: SJ
authors.lastname: Leischow
authors.forename: J P
authors.initials: JP
authors.lastname: McKenna
authors.forename: S I
authors.initials: SI
authors.lastname: Rennard
authors.forename: W C
authors.initials: WC
authors.lastname: Wadland
authors.forename: S A
authors.initials: SA
authors.lastname: Heatley
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage* / Q000494:pharmacology; D012044:Regression Analysis; D016540:Smoking Cessation / Q000379:methods*
chemical_list: D009538:Nicotine