Smoking reduction treatment with 4-mg nicotine gum: A double-blind, randomized, placebo-controlled study|[ast]|

doi:doi:10.1016/j.clpt.2005.08.019

Clinical Pharmacology & Therapeutics homepage

Clinical Pharmacology & Therapeutics (2005) 78, 689–696; doi: 10.1016/j.clpt.2005.08.019

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

Anil Batra MD^1,2,3, Karl Klingler MD^1,2,3, Björn Landfeldt MA^1,2,3, Hubertus M. Friederich MD^1,2,3, Åke Westin MSc^1,2,3 and Tobias Danielsson BSc^1,2,3

¹Department of Psychiatry and Psychotherapy, University Hospital of Tübingen, Tübingen
²Department of Pulmonary, Sleep and Critical Care Medicine, Klinik Hirslanden, Zürich
³Pfizer Consumer Healthcare, Helsingborg.

Correspondence: Anil Batra, MD, Universitätsklinik für Psychiatrie und Psychotherapie, Osianderstrasse 24, D-72076 Tübingen, Germany E-mail: anil.batra@med.uni-tuebingen.de

^*This study was supported by Pfizer Consumer Healthcare, Helsingborg, Sweden.

Received 23 November 2004; Accepted 24 August 2005.

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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.