Hostname: page-component-78c5997874-m6dg7 Total loading time: 0 Render date: 2024-11-13T14:12:38.223Z Has data issue: false hasContentIssue false
  • English
  • Français

A Pilot Study to Investigate the Efficacy of Nicotine Oral Soluble Film, Lozenge and Gum in Relief of Acute Smoking Cue-provoked Craving for Cigarette in Low Dependence Smokers

Published online by Cambridge University Press:  26 February 2014

Daniel Du ,
James Borders ,
Alex Selmani  and
William Waverczak
Daniel Du*
Affiliation:
GSK Consumer Healthcare, New Jersey
James Borders
Affiliation:
Central Kentucky Research Associates, Inc., Kentucky
Alex Selmani
Affiliation:
GSK Consumer Healthcare, New Jersey
William Waverczak
Affiliation:
GSK Consumer Healthcare, New Jersey
*
Address for correspondence: Daniel Du, GSK Consumer Healthcare, 1500 Littleton Road, Parsippany, New Jersey 07054 E-mail: daniel.y.du@gsk.com
Get access Rights & Permissions [Opens in a new window]

Abstract

Introduction: A new nicotine film that releases nicotine quickly may lead to faster craving relief.

Aims: This study compares the efficacy of 2.5 mg nicotine film with 2 mg nicotine lozenge and 2 mg nicotine gum on relieving provoked craving in low dependence smokers.

Methods: A randomised, open-label, active comparators controlled study was conducted in 120 subjects. Subjects were abstinent from smoking for 4 hours prior to being provoked with smoking cues. After post-provocation craving assessment, subjects were administered one dose of the 3 treatments: nicotine film, lozenge, or gum. Craving intensity was then assessed at 50 seconds, 3, 5, 7, 15, 20, 25 and 30 minutes after administration.

Results/Findings: Three treatments reduced craving with similar maximum effects. The effect was maintained up to 30 minutes. Nicotine film significantly reduced more craving than lozenge at 50 seconds, 3 and 5 minutes. It also significantly reduced more craving than gum at 50 seconds and 3 minutes. There was no significant difference between lozenge and gum.

Conclusions: Nicotine film, lozenge and gum have similar maximum craving relief. Nicotine film significantly reduced more craving than lozenge and gum at early time points. Nicotine film may be particularly useful to provide acute craving relief.

Keywords

smokingcravingsmoking cessationnicotine oral soluble filmnicotine lozengenicotine gumnicotine replacement therapylow dependence smokerprovocationnicotine strips
Type
Articles
Information
Journal of Smoking Cessation , Volume 10 , Issue 2 , December 2015 , pp. 87 - 95
Copyright
Copyright © The Author(s), published by Cambridge University Press on behalf of Australian Academic Press Pty Ltd 2014 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Behm, F. M., Schur, C., Levin, E. D., Tashkin, D. P., & Rose, J. D. (1993). Clinical evaluation of a citric acid inhaler for smoking cessation. Drug and Alcohol Dependence, 31, 131–138.Google Scholar
Bliss, R. E., Garvey, A. J., Heinhold, J. W., & Hitchock, J. L. (1989). The influence of situation and coping on relapse crisis outcomes after smoking cessation. Journal of Consulting and Clinical Psychology, 57, 443–449.Google Scholar
Cox, L. S., Tiffany, S. T., & Christen, A. G. (2001). Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine & Tobacco Research, 3, 7–16.CrossRefGoogle ScholarPubMed
Efron, B. & Tibshirani, R. J. (1993). Confidence intervals based on bootstrap percentiles. In Efron, B. & Tibshirani, R. J. (Eds.), An introduction to the bootstrap (pp.168–177). New York: Chapman & Hall/CRC.Google Scholar
Fiore, M. C., Jaen, C. R., Baker, T. B., et al. (2008). Treating Tobacco Use and Dependence: 2008 update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service.Google Scholar
Hansson, A., Perfekt, R., & Kraiczi, H. (2011). Craving relief with a novel nicotine mouth spray form of nicotine replacement therapy. Poster presented at the Society for Research on Nicotine and Tobacco 17th Annual Meeting, Toronto, Canada, February 16–19.Google Scholar
Heatherton, T. F., Kozlowski, L. T., Frecker, R. C., & Fagerstrom, K. O. (1991). The Fagerstrom test for nicotine dependence: a revision of the Fagerstrom Tolerance Questionnaire. British Journal of Addiction, 86, 1119–1127.Google Scholar
Jarvik, M. E., Madsen, D. C., Olmstead, R. E., Iwamoto-Schaap, P. N., Elins, J. L., & Benowitz, N. L. (2000). Nicotine blood levels and subjective craving for cigarettes. Pharmacology Biochemistry and Behavior, 66, 553–558.Google Scholar
Killen, J., & Fortman, S. (1997). Craving is associated with smoking relapse: findings from three prospective studies. Experimental Clinical Psychopharmacology, 5, 137–142.Google Scholar
Kraiczi, H., Hansson, A., & Perfekt, R. (2011). Single-dose pharmacokinetics of nicotine when given with a novel mouth spray for nicotine replacement therapy. Nicotine & Tobacco Research, 13, 1176–1182.Google Scholar
Le Foll, B., Melihan-Cheinin, P., Rostoker, G., & Lagrue, G. (2005). Smoking cessation guidelines: evidence-based recommendations of the French Health Products Safety Agency. European Psychiatry, 20, 431–41.Google Scholar
Levin, E. D., Behm, F., & Rose, J. D. (1990). The use of flavor in cigarette substitutes. Drug and Alcohol Dependence, 26, 155–160.Google Scholar
Niaura, R., Sayette, M., Shiffman, S., Glover, E. D., Nides, M., Shelanski, M., Shadel, W., Koslo, R., Robbins, B., & Sorrentino, J. (2005). Comparative efficacy of rapid-release nicotine gum versus nicotine polacrilex gum in relieving smoking cue-provoked craving. Addition, 100, 1720–1730.Google Scholar
Oliveira-Maia, A., Stapleton-Kotloski, J. R., Lyall, V., Phan, T. T., Mummalaneni, S., Melone, P., DeSimone, J. A., Nicolelis, M. A., & Simon, S. A. (2009). Nicotine activates TRPM5-dependent and independent taste pathways. Proceedings of the National Academy of Sciences USA, 106, 1596–1601.Google Scholar
Shiffman, S. (1982). Relapse following smoking cessation: a situational analysis. Journal of Consulting and Clinical Psychology, 50, 71–86.Google Scholar
Shiffman, S., Engberg, J. B., Paty, J. A., Perz, W. G., Gnys, M., Kassel, J. D., & Hickcox, M. (1997). A day at a time: predicting smoking lapse from daily urge. Journal of Abnormal Psychology, 106, 133–152.Google Scholar
Shiffman, S., Paty, J., Gnys, M., Kassel, J., & Hickox, M. (1996). First lapses to smoking: within subjects analysis of real time reports. Journal of Consulting and Clinical Psychology, 64, 366–379.Google Scholar
Shiffman, S., Shadel, W. G., Niaura, R., Khayrallah, M. A., Jorenby, D. E., Ryan, C. F., & Ferguson, C. L. (2003). Efficacy of acute administration of nicotine gum in relief of cue-provoked cigarette craving. Psychopharmacology, 166, 343–350.Google Scholar
West, R. & Schneider, N. (1987). Craving for cigarettes. British Journal of Addiction, 82, 407–415.Google Scholar
West, R., McNeill, A., & Raw, M. (2000). Smoking cessation guidelines for health professionals: an update. Thorax, 55, 987–99.Google Scholar
Zhou, X., Nonnemaker, J., Sherrill, B., Gilsenan, A. W., Coste, F., & West, R. (2009). Attempts to quit smoking and relapse: factors associated with success or failure from the ATTEMPT cohort study. Addictive Behaviors, 34, 365–373.Google Scholar