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Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial

Hansson, Anna LU ; Rasmussen, Thomas ; Perfekt, Roland LU ; Hall, Elin LU and Kraiczi, Holger LU (2019) In BMC Pharmacology and Toxicology 20(1).
Abstract

Background: Ability to manage urges to smoke is fundamental to maximizing the chances of success in smoking cessation. Previous studies have linked a higher dose of nicotine in nicotine replacement therapy to a higher success rate for smoking cessation. Thus, this study was performed to compare relief of urges to smoke, up until 5 h following treatment with a new 6 mg nicotine gum versus currently marketed 4 mg nicotine gum. Methods: This was a randomized crossover clinical study. Following 12 h of abstinence from smoking, either one 6 mg or one 4 mg nicotine gum was given to 240 healthy adult smokers. Thereafter, urges to smoke were scored on a 100 mm Visual Analogue Scale repeatedly over 5 h. Results: The reductions in urges to smoke... (More)

Background: Ability to manage urges to smoke is fundamental to maximizing the chances of success in smoking cessation. Previous studies have linked a higher dose of nicotine in nicotine replacement therapy to a higher success rate for smoking cessation. Thus, this study was performed to compare relief of urges to smoke, up until 5 h following treatment with a new 6 mg nicotine gum versus currently marketed 4 mg nicotine gum. Methods: This was a randomized crossover clinical study. Following 12 h of abstinence from smoking, either one 6 mg or one 4 mg nicotine gum was given to 240 healthy adult smokers. Thereafter, urges to smoke were scored on a 100 mm Visual Analogue Scale repeatedly over 5 h. Results: The reductions in urges to smoke over the first 1 and 3 h after administration were statistically significantly greater with 6 mg than 4 mg gum, (p < 0.005). A 50% reduction in perceived urges to smoke was reached in 9.4 min with 6 mg gum compared to 16.2 min with 4 mg gum (median values). The median duration of a 50% or more reduction in VAS urges to smoke score was 111 min with the 6 mg gum, versus 74 min for the 4 mg gum. Conclusion: This study provides evidence that the 6 mg nicotine gum provided a greater reduction, faster and longer relief of urges to smoke than the 4 mg nicotine gum. Trial registration: EudraCT Number: 2010-023268-42. Study was first entered in EudraCT 2011-02-23.

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author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Clinical trial, Craving relief, Nicotine replacement therapy, Smoking cessation, Urges to smoke
in
BMC Pharmacology and Toxicology
volume
20
issue
1
article number
69
publisher
BioMed Central (BMC)
external identifiers
  • pmid:31753009
  • scopus:85075536582
ISSN
2050-6511
DOI
10.1186/s40360-019-0368-9
language
English
LU publication?
yes
id
65954ba1-107e-4101-b438-a4e2b0e367b1
date added to LUP
2019-12-05 08:39:12
date last changed
2024-09-04 13:53:38
@article{65954ba1-107e-4101-b438-a4e2b0e367b1,
  abstract     = {{<p>Background: Ability to manage urges to smoke is fundamental to maximizing the chances of success in smoking cessation. Previous studies have linked a higher dose of nicotine in nicotine replacement therapy to a higher success rate for smoking cessation. Thus, this study was performed to compare relief of urges to smoke, up until 5 h following treatment with a new 6 mg nicotine gum versus currently marketed 4 mg nicotine gum. Methods: This was a randomized crossover clinical study. Following 12 h of abstinence from smoking, either one 6 mg or one 4 mg nicotine gum was given to 240 healthy adult smokers. Thereafter, urges to smoke were scored on a 100 mm Visual Analogue Scale repeatedly over 5 h. Results: The reductions in urges to smoke over the first 1 and 3 h after administration were statistically significantly greater with 6 mg than 4 mg gum, (p &lt; 0.005). A 50% reduction in perceived urges to smoke was reached in 9.4 min with 6 mg gum compared to 16.2 min with 4 mg gum (median values). The median duration of a 50% or more reduction in VAS urges to smoke score was 111 min with the 6 mg gum, versus 74 min for the 4 mg gum. Conclusion: This study provides evidence that the 6 mg nicotine gum provided a greater reduction, faster and longer relief of urges to smoke than the 4 mg nicotine gum. Trial registration: EudraCT Number: 2010-023268-42. Study was first entered in EudraCT 2011-02-23.</p>}},
  author       = {{Hansson, Anna and Rasmussen, Thomas and Perfekt, Roland and Hall, Elin and Kraiczi, Holger}},
  issn         = {{2050-6511}},
  keywords     = {{Clinical trial; Craving relief; Nicotine replacement therapy; Smoking cessation; Urges to smoke}},
  language     = {{eng}},
  month        = {{11}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{BMC Pharmacology and Toxicology}},
  title        = {{Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial}},
  url          = {{http://dx.doi.org/10.1186/s40360-019-0368-9}},
  doi          = {{10.1186/s40360-019-0368-9}},
  volume       = {{20}},
  year         = {{2019}},
}