Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial
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 comp...
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| Format: | Article |
| Language: | English |
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BMC
2019-11-01
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| Series: | BMC Pharmacology and Toxicology |
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| Online Access: | http://link.springer.com/article/10.1186/s40360-019-0368-9 |
| _version_ | 1818935188204290048 |
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| author | Anna Hansson Thomas Rasmussen Roland Perfekt Elin Hall Holger Kraiczi |
| author_facet | Anna Hansson Thomas Rasmussen Roland Perfekt Elin Hall Holger Kraiczi |
| author_sort | Anna Hansson |
| collection | DOAJ |
| description | 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 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. |
| first_indexed | 2024-12-20T05:16:12Z |
| format | Article |
| id | doaj.art-4ba6331c00b449d6b8b258c81f6e2b32 |
| institution | Directory Open Access Journal |
| issn | 2050-6511 |
| language | English |
| last_indexed | 2024-12-20T05:16:12Z |
| publishDate | 2019-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pharmacology and Toxicology |
| spelling | doaj.art-4ba6331c00b449d6b8b258c81f6e2b322022-12-21T19:52:09ZengBMCBMC Pharmacology and Toxicology2050-65112019-11-012011710.1186/s40360-019-0368-9Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trialAnna Hansson0Thomas Rasmussen1Roland Perfekt2Elin Hall3Holger Kraiczi4Global Clinical Pharmacology, McNeil ABQuantitative Sciences, McNeil ABQuantitative Sciences, McNeil ABGlobal Clinical Pharmacology, McNeil ABDepartment of Statistics, Lund University School of Economics and ManagementAbstract 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.http://link.springer.com/article/10.1186/s40360-019-0368-9Nicotine replacement therapySmoking cessationUrges to smokeCraving reliefClinical trial |
| spellingShingle | Anna Hansson Thomas Rasmussen Roland Perfekt Elin Hall Holger Kraiczi Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial BMC Pharmacology and Toxicology Nicotine replacement therapy Smoking cessation Urges to smoke Craving relief Clinical trial |
| title | Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial |
| title_full | Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial |
| title_fullStr | Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial |
| title_full_unstemmed | Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial |
| title_short | Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial |
| title_sort | effect of nicotine 6 mg gum on urges to smoke a randomized clinical trial |
| topic | Nicotine replacement therapy Smoking cessation Urges to smoke Craving relief Clinical trial |
| url | http://link.springer.com/article/10.1186/s40360-019-0368-9 |
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