Nicotine & Tobacco Research Advance Access originally published online on May 19, 2009
Nicotine & Tobacco Research 2009 11(6):715-721; doi:10.1093/ntr/ntp054
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A single-blind, randomized, crossover trial of the effects of a nicotine pouch on the relief of tobacco withdrawal symptoms and user satisfaction
Simon Thornley, M.B., Ch.B., M.P.H., Epidemiology and Biostatistics, School of Population Health, University of Auckland, Auckland, New Zealand
Hayden McRobbie, M.B., Ch.B., Ph.D., Wolfson Institute of Preventive Medicine, UK Centre for Tobacco Control Studies, Barts and The London, Queen Mary University of London, United Kingdom
Ruey-Bin Lin, M.Sc., Covance Pty Ltd., Macquarie University Research Park, North Ryde, New South Wales, Australia
Chris Bullen, M.B.Ch.B., M.P.H., Clinical Trials Research Unit, School of Population Health, University of Auckland, Auckland, New Zealand
Peter Hajek, Ph.D., Wolfson Institute of Preventive Medicine, UK Centre for Tobacco Control Studies, Barts and The London, Queen Mary University of London, United Kingdom
Murray Laugesen, Q.S.O., M.B.Ch.B., F.N.Z.C.P.H.M., Health New Zealand Ltd, Lyttelton, Christchurch, New Zealand
Hugh Senior, DPH M.Sc., Ph.D., George Institute for International Health, University of Sydney, Sydney, Australia
Robyn Whittaker, M.B.Ch.B., M.P.H., Clinical Trials Research Unit, School of Population Health, University of Auckland, Auckland, New Zealand
Corresponding Author: Hayden McRobbie, M.B., Ch.B., Ph.D., Wolfson Institute of Preventive Medicine, UK Centre for Tobacco Control Studies, Barts and The London, Queen Mary University of London, United Kingdom. Telephone: +44 20 7882 8231; Fax: +44 20 7377 7237; E-mail: h.j.mcrobbie{at}qmul.ac.uk
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Abstract |
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Introduction: We compared the effects of a 4-mg oral nicotine pouch (Zonnic pouch), with nicotine chewing gum and placebo pouch, on withdrawal discomfort after overnight tobacco abstinence. We also assessed participants’ preferences, satisfaction, and consumption patterns.
Methods: This was a randomized, placebo-controlled, three-way crossover study of 30 adult smokers. After overnight tobacco abstinence, subjects reported on a Visual Analog Scale (VAS; 0–100) tobacco withdrawal symptoms (craving, irritability, difficulty concentrating, and restlessness) before use and during the first hour after first product use. They then used the product throughout the study day and in the evening reported product usefulness, temporary abstinence success, and satisfaction.
Results: In a multivariate analysis, area under the curve (craving vs. time) was reduced by 23 points 60 min after taking the study medication in the nicotine pouch group, compared with 15- and 8-point decreases in the gum and placebo groups, respectively. The difference in craving ratings between the pouch and placebo was significant (p = .002). Nicotine pouch reduced irritability more than gum (difference = 9.86; p = .01). For pouch users, the odds ratio for temporary tobacco abstinence (21.5 hr) during study days (compared with gum) was 2.8 (95% CI = 0.8–8.1). Compared with the gum, the pouch was rated as significantly more "helpful to stop smoking" (difference = 20.6; 95% CI = 2.4–38.9) and "pleasant to use" (difference = 17.3; 95% CI = 2.6–32.0).
Discussion: The Zonnic pouch appears to be as effective at relieving craving as nicotine gum and was subjectively favored over the gum. These results suggest that the pouch will be a helpful addition to the range of existing nicotine replacement treatments.
Received: July 8, 2008; Accepted: February 26, 2009
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