Clinical Research Details

Descriptive Information
Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

Hassan Chami


Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 4  

Conditions and Keywords
Determine the efficacy of Varenicline (Chantix) administered for 12 weeks as a waterpipe smoking cessation treatment in comparison with a matched placebo
Varenicline,Smoking cessation,Placebo,Chantix
Study Design
Double Blind
Eligibility and IRB
Min: 18

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.