Smoking reduction treatment with 4-mg nicotine gum: a double-blind, randomized, placebo-controlled study

Clin Pharmacol Ther. 2005 Dec;78(6):689-96. doi: 10.1016/j.clpt.2005.08.019.

Abstract

Background: Smoking reduction may provide a harm-reduction alternative treatment for smokers who are not ready to quit smoking. This study evaluated the efficacy of nicotine gum in helping smokers reduce or quit smoking.

Methods: This randomized, double-blind, placebo-controlled trial involved 364 smokers who were not ready to quit but were willing to reduce their smoking intensity. Participants received either 4-mg nicotine gum (n = 184) or placebo gum (n = 180) as desired for up to 12 months. The primary outcome was sustained smoking reduction, which was defined as a decrease in daily cigarette consumption of at least 50% compared with baseline. Secondary measures included point-prevalence abstinence, intention to quit, and cardiovascular risk markers.

Results: At 4 months, the sustained smoking reduction rate in the nicotine gum group was twice that of the placebo group (15.8% versus 6.7%, P = .008). Point-prevalence abstinence was 6.6% for the nicotine gum group and 2.2% for the placebo group (P = .07). At 13 months, there was a significant difference in the smoking reduction rate for the nicotine (8.2%) and placebo (2.8%) groups (P = .036). At month 13, the abstinence rates were 12% and 4.5% for the nicotine and placebo groups, respectively (P = .012). Concomitant use of nicotine gum and cigarette smoking was well tolerated. Carbon monoxide levels decreased significantly (P = .01).

Conclusion: Nicotine gum may be an efficacious harm-reduction alternative for smokers who are not ready to quit and may promote smoking cessation, the ultimate goal in the treatment of tobacco dependence.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Breath Tests / methods
  • Carbon Dioxide / analysis
  • Carbon Monoxide / analysis
  • Chewing Gum
  • Cotinine / blood
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Nicotine / administration & dosage
  • Nicotine / therapeutic use*
  • Nicotinic Agonists / administration & dosage
  • Nicotinic Agonists / therapeutic use
  • Patient Compliance / psychology
  • Patient Compliance / statistics & numerical data
  • Smoking Cessation / methods*
  • Smoking Cessation / psychology
  • Smoking Cessation / statistics & numerical data
  • Smoking Prevention
  • Thiocyanates / blood
  • Time Factors
  • Treatment Outcome

Substances

  • Chewing Gum
  • Nicotinic Agonists
  • Thiocyanates
  • Carbon Dioxide
  • Nicotine
  • Carbon Monoxide
  • Cotinine
  • thiocyanate