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

Abstract

BackgroundWaterpipe 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/designThis 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.DiscussionThis is an efficacy trial and would require a subsequent effectiveness trial for a definitive evaluation of the intervention.Trial registrationISRCTN, ISRCTN94103375. Registered on 1 December 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1761-y) contains supplementary material, which is available to authorized users.

Water Pipe (Hookah) Smoking and Cardiovascular Disease Risk: A Scientific Statement From the American Heart Association

“…Data from controlled trials are not yet available to determine the efficacy of pharmacological interventions, but a double-blind randomized controlled trial is underway to test the efficacy of varenicline for water pipe cessation. 145…”

Varenicline versus placebo for waterpipe smoking cessation: a double‐blind randomized controlled trial

“…We obtained ethics approval from the respective research ethics committees at the Pakistan Health Research Council, all participating hospitals and the University of York. The trial protocol has been published elsewhere .…”

“…We had procedures to identify, record, report and manage adverse events . All trial participants were encouraged to report and researchers were trained to enquire, record, report and assess (medically qualified researcher only) any such events throughout the participants’ follow‐up.…”

Factors associated with dual use of waterpipe tobacco and cigarettes among adults in Pakistan

“…Data were analysed from participants recruited to a randomized controlled trial in 2016 testing the effect of varenicline on smoking cessation among adult waterpipe smokers in Pakistan (23). The trial protocol and full methods are published elsewhere (26). Briefly, the study recruited adult participants from four districts of Punjab, Pakistan, who smoked waterpipe tobacco daily (> 25 days a month) for at least six months.…”