Cargando…
The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial
BACKGROUND: Waterpipe tobacco smoking has increased among youth across the globe including in the US, and it continues as a common and traditional form of smoking tobacco in Pakistan. A range of behavioral and pharmacological therapies are available to support people in quitting cigarette smoking; h...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5225555/ https://www.ncbi.nlm.nih.gov/pubmed/28077163 http://dx.doi.org/10.1186/s13063-016-1761-y |
_version_ | 1782493530742063104 |
---|---|
author | Zahid, Raana Dogar, Omara Mansoor, Sonia Khan, Amina Kanaan, Mona Jawad, Mohammed Ahluwalia, Jasjit S. Siddiqi, Kamran |
author_facet | Zahid, Raana Dogar, Omara Mansoor, Sonia Khan, Amina Kanaan, Mona Jawad, Mohammed Ahluwalia, Jasjit S. Siddiqi, Kamran |
author_sort | Zahid, Raana |
collection | PubMed |
description | BACKGROUND: Waterpipe tobacco smoking has increased among youth across the globe including in the US, and it continues as a common and traditional form of smoking tobacco in Pakistan. A range of behavioral and pharmacological therapies are available to support people in quitting cigarette smoking; however, little evidence exists for the efficacy of these therapies in achieving abstinence among waterpipe tobacco smokers. The objective of this study is to assess the efficacy of varenicline when added to behavioral support for waterpipe tobacco smoking cessation, by measuring biochemically validated continuous abstinence in waterpipe tobacco smokers. METHODS/DESIGN: This is a two-arm, double-blind, placebo-controlled randomized trial conducted in four districts in Punjab, Pakistan. Study participants include adults using a waterpipe (with or without concomitant cigarette, bidi or other forms of tobacco smoking) on a daily basis for at least 6 months and who are willing to quit. We will individually randomize 510 participants to one of the two arms of the trial. Participants in the intervention arm will receive varenicline and behavioral support and those in the control arm will receive placebo and behavioral support. The primary outcome will be continuous abstinence for at least 6 months (week 25) which is biochemically verified by a carbon monoxide level of <10 ppm. Secondary outcomes will include biochemically verified 7-day point abstinence at 5, 12 and 25 weeks and any lapses and relapses between the different assessment points. Tertiary outcomes will include assessment of withdrawal symptoms using the Mood and Physical Symptoms Scale (MPSS), smoking dependency using the Lebanon Waterpipe Dependency Scale (LWDS-11) and monitoring adverse outcomes. DISCUSSION: This is an efficacy trial and would require a subsequent effectiveness trial for a definitive evaluation of the intervention. TRIAL REGISTRATION: ISRCTN, ISRCTN94103375. Registered on 1 December 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1761-y) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5225555 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-52255552017-01-17 The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial Zahid, Raana Dogar, Omara Mansoor, Sonia Khan, Amina Kanaan, Mona Jawad, Mohammed Ahluwalia, Jasjit S. Siddiqi, Kamran Trials Study Protocol BACKGROUND: Waterpipe tobacco smoking has increased among youth across the globe including in the US, and it continues as a common and traditional form of smoking tobacco in Pakistan. A range of behavioral and pharmacological therapies are available to support people in quitting cigarette smoking; however, little evidence exists for the efficacy of these therapies in achieving abstinence among waterpipe tobacco smokers. The objective of this study is to assess the efficacy of varenicline when added to behavioral support for waterpipe tobacco smoking cessation, by measuring biochemically validated continuous abstinence in waterpipe tobacco smokers. METHODS/DESIGN: This is a two-arm, double-blind, placebo-controlled randomized trial conducted in four districts in Punjab, Pakistan. Study participants include adults using a waterpipe (with or without concomitant cigarette, bidi or other forms of tobacco smoking) on a daily basis for at least 6 months and who are willing to quit. We will individually randomize 510 participants to one of the two arms of the trial. Participants in the intervention arm will receive varenicline and behavioral support and those in the control arm will receive placebo and behavioral support. The primary outcome will be continuous abstinence for at least 6 months (week 25) which is biochemically verified by a carbon monoxide level of <10 ppm. Secondary outcomes will include biochemically verified 7-day point abstinence at 5, 12 and 25 weeks and any lapses and relapses between the different assessment points. Tertiary outcomes will include assessment of withdrawal symptoms using the Mood and Physical Symptoms Scale (MPSS), smoking dependency using the Lebanon Waterpipe Dependency Scale (LWDS-11) and monitoring adverse outcomes. DISCUSSION: This is an efficacy trial and would require a subsequent effectiveness trial for a definitive evaluation of the intervention. TRIAL REGISTRATION: ISRCTN, ISRCTN94103375. Registered on 1 December 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1761-y) contains supplementary material, which is available to authorized users. BioMed Central 2017-01-11 /pmc/articles/PMC5225555/ /pubmed/28077163 http://dx.doi.org/10.1186/s13063-016-1761-y Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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. |
spellingShingle | Study Protocol Zahid, Raana Dogar, Omara Mansoor, Sonia Khan, Amina Kanaan, Mona Jawad, Mohammed Ahluwalia, Jasjit S. Siddiqi, Kamran The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial |
title | The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial |
title_full | The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial |
title_fullStr | The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial |
title_full_unstemmed | The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial |
title_short | The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial |
title_sort | efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5225555/ https://www.ncbi.nlm.nih.gov/pubmed/28077163 http://dx.doi.org/10.1186/s13063-016-1761-y |
work_keys_str_mv | AT zahidraana theefficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT dogaromara theefficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT mansoorsonia theefficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT khanamina theefficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT kanaanmona theefficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT jawadmohammed theefficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT ahluwaliajasjits theefficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT siddiqikamran theefficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT zahidraana efficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT dogaromara efficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT mansoorsonia efficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT khanamina efficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT kanaanmona efficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT jawadmohammed efficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT ahluwaliajasjits efficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial AT siddiqikamran efficacyofvareniclineinachievingabstinenceamongwaterpipetobaccosmokersstudyprotocolforarandomizedcontrolledtrial |