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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial

Authors: Raana Zahid, Omara Dogar, Sonia Mansoor, Amina Khan, Mona Kanaan, Mohammed Jawad, Jasjit S. Ahluwalia, Kamran Siddiqi

Published in: Trials | Issue 1/2017

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Abstract

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.
Appendix
Available only for authorised users
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Metadata
Title
The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial
Authors
Raana Zahid
Omara Dogar
Sonia Mansoor
Amina Khan
Mona Kanaan
Mohammed Jawad
Jasjit S. Ahluwalia
Kamran Siddiqi
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1761-y

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