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The efficacy of varenicline in achieving abstinence among hookah smokers: A two-arm, double blind, randomised, placebo controlled trial

Hookah (Waterpipe) smoking has increased among young people across the world including in the US. It continues to be a common and traditional form of smoking tobacco in Pakistan. A range of behavioural and pharmacological therapies are available to support people who want to quit smoking cigarettes, however, little evidence exists on the efficacy of these therapies in achieving abstinence among hookah smokers.

Our objective is to assess the efficacy of varenicline when added to behavioural support for smoking cessation, by measuring biochemically validated continuous abstinence in hookah smokers. We are conducting a two-arm, double blind, randomised, placebo-controlled trial in three district hospitals in Punjab, Pakistan. Adults, using hookah (with or without concomitant cigarette, bidi, or other tobacco smoking) on a daily basis for at least six-months who are willing to quit smoking, will be eligible. We will individually randomise 510 participants to one of the two arms of the trial. Arm 1 will be offered Varenicline and behavioural support and arm 2 will be offered a placebo and behavioural support.

As per Russell’s Standard, the primary outcome assessed will be continuous abstinence for at least six months which is biochemically verified by a carbon monoxide level of <10ppm at 5, 12 and 25 weeks post-randomisation. Secondary outcomes will include, biochemically verified 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 Lebanon Waterpipe Dependency Scale (LWDS-11), and the monitoring of adverse outcomes. This is the first pharmacological intervention trial of hookah (waterpipe) cessation in the world and, if successful, has the potential for significant global impact.