title: The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers - study protocol for a randomized controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  This is an efficacy trial and would require a subsequent effectiveness trial for a definitive evaluation of the intervention.
  
  
  
  ISRCTN, ISRCTN94103375 . Registered on 1 December 2015.
authors.affiliation: The Initiative, Islamabad, Pakistan. dr_raana@yahoo.com.|Orange Grove Farm, Korung Road, Banigala, Islamabad, Pakistan. dr_raana@yahoo.com.
authors.forename: Raana
authors.initials: R
authors.lastname: Zahid
authors.affiliation: Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington, York, YO10 5DD, UK.
authors.forename: Omara
authors.initials: O
authors.lastname: Dogar
authors.affiliation: The Initiative, Islamabad, Pakistan.|Orange Grove Farm, Korung Road, Banigala, Islamabad, Pakistan.
authors.forename: Sonia
authors.initials: S
authors.lastname: Mansoor
authors.affiliation: Orange Grove Farm, Korung Road, Banigala, Islamabad, Pakistan.
authors.forename: Amina
authors.initials: A
authors.lastname: Khan
authors.affiliation: Department of Health Sciences, University of York, ARRC Building, Heslington, York, YO10 5DD, UK.
authors.forename: Mona
authors.initials: M
authors.lastname: Kanaan
authors.affiliation: Department of Primary Care and Public Health, Imperial College London, Hammersmith, W6 8RP, UK.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Jawad
authors.affiliation: , Milltown, NJ, USA.
authors.forename: Jasjit S
authors.initials: JS
authors.lastname: Ahluwalia
authors.affiliation: Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington, York, YO10 5DD, UK.
authors.forename: Kamran
authors.initials: K
authors.lastname: Siddiqi
mesh_terms: D000339:Affect / Q000187:drug effects; D001521:Behavior Therapy / Q000379:methods*; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D006801:Humans; D018722:Nicotinic Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D010154:Pakistan; D012008:Recurrence; D012107:Research Design; D000074285:Smokers / Q000523:psychology*; D016540:Smoking Cessation / Q000379:methods* / Q000523:psychology; D000075387:Smoking Water Pipes; D013997:Time Factors; D061485:Tobacco Use Cessation Devices / Q000009:adverse effects; D000073846:Tobacco, Waterpipe / Q000009:adverse effects*; D016896:Treatment Outcome; D000068580:Varenicline / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018722:Nicotinic Agonists; D000068580:Varenicline
keywords: Abstinence; Behavioral support; Cessation; Hookah; Pharmacotherapy; Shisha; Smoking; Tobacco; Varenicline; Waterpipe