Cargando…
Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial
BACKGROUND: Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive; as such, there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replace...
Autores principales: | , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7325031/ https://www.ncbi.nlm.nih.gov/pubmed/32600406 http://dx.doi.org/10.1186/s13063-020-04532-7 |
_version_ | 1783552075633786880 |
---|---|
author | Zawertailo, Laurie Hendershot, Christian S. Tyndale, Rachel F. Le Foll, Bernard Samokhvalov, Andriy V. Thorpe, Kevin E. Pipe, Andrew Reid, Robert D. Selby, Peter |
author_facet | Zawertailo, Laurie Hendershot, Christian S. Tyndale, Rachel F. Le Foll, Bernard Samokhvalov, Andriy V. Thorpe, Kevin E. Pipe, Andrew Reid, Robert D. Selby, Peter |
author_sort | Zawertailo, Laurie |
collection | PubMed |
description | BACKGROUND: Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive; as such, there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replacement therapy are not effective for many smokers, and in many cases, the amount of nicotine provided is much less than when a smoker is smoking their usual number of cigarettes. The proposed study will test if titrating the dose of the nicotine patch (up to 84 mg) will improve quitting success compared to those receiving a 21-mg nicotine patch with increasing doses of placebo patch. METHODS: This is a multicenter, pragmatic, two-arm, placebo-controlled, block randomized controlled trial. We will recruit participants who smoke at least 10 cigarettes daily and are interested in making a quit attempt. After 2 weeks of usual treatment with a 21-mg patch, participants who fail to quit smoking (target n = 400) will be randomized to receive escalating doses of a nicotine patch vs matching placebo patches for an additional 10 weeks or up to a maximum dose of 84 mg per day. Those who stop smoking during the first 2 weeks of usual treatment will continue with 21 mg patch treatment for 10 weeks and will form an additional comparison arm. In addition to the medication, participants will receive brief behavioral counseling at each study visit. The primary outcome will be biochemically confirmed continuous abstinence from smoking during the last 4 weeks of treatment (weeks 9 to 12). DISCUSSION: Research evidence supporting the effectiveness of personalized doses of nicotine replacement therapy could change current practice in a variety of healthcare settings. Given the evidence that quitting smoking at any age diminishes the risk of tobacco-related morbidity and mortality, even small increases in absolute quit rates can have a substantial population-level impact on reducing smoking-related disease, mortality rates, and associated healthcare costs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03000387. Registered on 22 December 2016. |
format | Online Article Text |
id | pubmed-7325031 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-73250312020-06-30 Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial Zawertailo, Laurie Hendershot, Christian S. Tyndale, Rachel F. Le Foll, Bernard Samokhvalov, Andriy V. Thorpe, Kevin E. Pipe, Andrew Reid, Robert D. Selby, Peter Trials Study Protocol BACKGROUND: Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive; as such, there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replacement therapy are not effective for many smokers, and in many cases, the amount of nicotine provided is much less than when a smoker is smoking their usual number of cigarettes. The proposed study will test if titrating the dose of the nicotine patch (up to 84 mg) will improve quitting success compared to those receiving a 21-mg nicotine patch with increasing doses of placebo patch. METHODS: This is a multicenter, pragmatic, two-arm, placebo-controlled, block randomized controlled trial. We will recruit participants who smoke at least 10 cigarettes daily and are interested in making a quit attempt. After 2 weeks of usual treatment with a 21-mg patch, participants who fail to quit smoking (target n = 400) will be randomized to receive escalating doses of a nicotine patch vs matching placebo patches for an additional 10 weeks or up to a maximum dose of 84 mg per day. Those who stop smoking during the first 2 weeks of usual treatment will continue with 21 mg patch treatment for 10 weeks and will form an additional comparison arm. In addition to the medication, participants will receive brief behavioral counseling at each study visit. The primary outcome will be biochemically confirmed continuous abstinence from smoking during the last 4 weeks of treatment (weeks 9 to 12). DISCUSSION: Research evidence supporting the effectiveness of personalized doses of nicotine replacement therapy could change current practice in a variety of healthcare settings. Given the evidence that quitting smoking at any age diminishes the risk of tobacco-related morbidity and mortality, even small increases in absolute quit rates can have a substantial population-level impact on reducing smoking-related disease, mortality rates, and associated healthcare costs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03000387. Registered on 22 December 2016. BioMed Central 2020-06-29 /pmc/articles/PMC7325031/ /pubmed/32600406 http://dx.doi.org/10.1186/s13063-020-04532-7 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Zawertailo, Laurie Hendershot, Christian S. Tyndale, Rachel F. Le Foll, Bernard Samokhvalov, Andriy V. Thorpe, Kevin E. Pipe, Andrew Reid, Robert D. Selby, Peter Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial |
title | Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial |
title_full | Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial |
title_fullStr | Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial |
title_full_unstemmed | Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial |
title_short | Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial |
title_sort | personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7325031/ https://www.ncbi.nlm.nih.gov/pubmed/32600406 http://dx.doi.org/10.1186/s13063-020-04532-7 |
work_keys_str_mv | AT zawertailolaurie personalizeddosingofnicotinereplacementtherapyversusstandarddosingforthetreatmentofindividualswithtobaccodependencestudyprotocolforarandomizedplacebocontrolledtrial AT hendershotchristians personalizeddosingofnicotinereplacementtherapyversusstandarddosingforthetreatmentofindividualswithtobaccodependencestudyprotocolforarandomizedplacebocontrolledtrial AT tyndalerachelf personalizeddosingofnicotinereplacementtherapyversusstandarddosingforthetreatmentofindividualswithtobaccodependencestudyprotocolforarandomizedplacebocontrolledtrial AT lefollbernard personalizeddosingofnicotinereplacementtherapyversusstandarddosingforthetreatmentofindividualswithtobaccodependencestudyprotocolforarandomizedplacebocontrolledtrial AT samokhvalovandriyv personalizeddosingofnicotinereplacementtherapyversusstandarddosingforthetreatmentofindividualswithtobaccodependencestudyprotocolforarandomizedplacebocontrolledtrial AT thorpekevine personalizeddosingofnicotinereplacementtherapyversusstandarddosingforthetreatmentofindividualswithtobaccodependencestudyprotocolforarandomizedplacebocontrolledtrial AT pipeandrew personalizeddosingofnicotinereplacementtherapyversusstandarddosingforthetreatmentofindividualswithtobaccodependencestudyprotocolforarandomizedplacebocontrolledtrial AT reidrobertd personalizeddosingofnicotinereplacementtherapyversusstandarddosingforthetreatmentofindividualswithtobaccodependencestudyprotocolforarandomizedplacebocontrolledtrial AT selbypeter personalizeddosingofnicotinereplacementtherapyversusstandarddosingforthetreatmentofindividualswithtobaccodependencestudyprotocolforarandomizedplacebocontrolledtrial |