The lack of proven waterpipe smoking cessation interventions makes it
important to explore interventions proven effective for cigarette smoking
cessation. We hypothesize that Varenicline (Chantix) administrated for 12 weeks
is associated with higher sustained quit rate at 12 weeks compared to placebo. We
proposed to conduct a randomized double-blind placebo-controlled trial that will
evaluate the effect of Varenicline (Chantix), in two parallel groups each
consisting of 76 habitual waterpipe smokers who are willing to quit. Potential
participants will be approached in cafés, word-of-mouth and through media and
will be invited to the American University of Beirut Medical Center to complete
study procedures. Both study groups will receive the same behavioural
intervention in combination with either Varenicline (Chantix), an FDA approved
drug indicated for use as an aid to smoking cessation treatment, or placebo.
Participants will complete study procedures in four visits. During visit-1 the
informed consent process, baseline assessments and randomization will be
completed and Varenicline (Chantix) or Placebo will be initiated together with
the behavioural interventions. The
behavioural intervention will be continued over the next 2 visits. An end of
treatment visit 12 weeks after quit date will be dedicated to assessing
sustained quit rate and other outcomes.
152 daily waterpipe smokers (76 per group) from the community of Beirut
Potential participants will be approached directly in cafés and university campus and through media advertisement, social media, flyers, word-of-mouth, and at the smoking cessation clinic. We will also contact well characterized habitual waterpipe smokers from the community who have participated in other studies at our center and have previously consented to be re-contacted for other studies. The 152 participants will be randomly assigned to two equal groups. Block randomization will be used to achieve equal allocation of participants in groups. Randomization will be stratified by gender, age, and nicotine dependence score (from the LWDS-11) to ensure comparable intervention groups with respect to these characteristics.
Daily waterpipe smokers from the community of Beirut, aged 18 years or older and willing to quit will be invited to participate in the study.
Cigarette and/or cigars smokers, individuals with history of psychiatric diseases (Depression, bipolar disorder, schizophrenia, prior suicide attempt) or on psychotropic medications, renal failure, cardiovascular disease (coronary heart disease and congestive heart failure), and active malignancy will be excluded from the study. Pregnant women will also be excluded.