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A Multicenter Phase 3 Trial of Lobeline Sulfate for Smoking Cessation

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Objective: To evaluate the safety and efficacy of sublingual lobeline sulfate for smoking cessation.

Methods: A multicenter (3 sites), double-blind, parallel, placebo-controlled, phase 3 smoking cessation trial of sublingual formulation of lobeline sulfate. A total of 750 smokers (250 per site) were randomized to either treatment (lobeline sulfate) or placebo with individual smoking cessation counseling lasting up to approximately 10 minutes.

Results: Efficacy revealed no statistical significance (P = 0.62) for lobeline sulfate as a smoking cessation aid.

Conclusion: Sublingual formulation of lobeline sulfate does not appear to be an effective smoking cessation aid.

Keywords: clinical trials; lobeline sulfate; smoking cessation

Document Type: Research Article


Publication date: January 1, 2010

More about this publication?
  • The American Journal of Health Behavior seeks to improve the quality of life through multidisciplinary health efforts in fostering a better understanding of the multidimensional nature of both individuals and social systems as they relate to health behaviors.

    The Journal aims to provide a comprehensive understanding of the impact of personal attributes, personality characteristics, behavior patterns, social structure, and processes on health maintenance, health restoration, and health improvement; to disseminate knowledge of holistic, multidisciplinary approaches to designing and implementing effective health programs; and to showcase health behavior analysis skills that have been proven to affect health improvement and recovery.

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