Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

Study Overview
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Brief Summary
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The lack of proven waterpipe smoking cessation interventions makes it important to explore interventions proven effective for cigarette smoking cessation. The investigators hypothesize that Varenicline (Chantix) administrated for 12 weeks is associated with higher sustained quit rate at 12 weeks compared to placebo. The investigators propose 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.

Official Title
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Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Drug: Varinecline (Chantix)
* Drug: Placebo (for Varenicline)
* Behavioral: Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Daily waterpipe smokers from the community of Beirut, aged 18 years or older willing to quit Exclusion Criteria: Cigarette and/or cigars smokers, active malignancy Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline (Chantix)<br>76 participants will be assigned to 4 behavioral therapy cessation for smoking cessation and will be randomized to receive Varinecline with instructions for administration for 12 weeks starting 1 week before Smoking Quit Date as suggested by the manufacturer: Days 1 to 3: 0.5 mg orally once a day Days 4 to 7: 0.5 mg orally twice a day Days 8 to end of treatment: 1 mg orally twice a day. Intervention 'Varinecline (Chantix)' and Intervention 'Behavioral Therapy' | Drug: Varinecline (Chantix)<br>* A randomized double-blind placebo-controlled trial that will evaluate the effect of Varenicline (Chantix), in 2 parallel groups of habitual waterpipe smokers who are willing to quit (n=152). 76 subjects will be randomized to receive varenicline (Chantix). The participants, study investigators and personnel who will be interviewing the participants and collecting the clinical data, will be blinded to the assigned treatment.<br>Behavioral: Behavioral Therapy<br>* This intervention is for all study participants and it involves 4 visits to the hospital. Each visit include a 30-min one-on-one individual session with the specialized therapist during which participants will be taught how to manage any withdrawal symptoms they experience, how to anticipate high-risk situations, deal with smoking triggers, achieve and maintain their goal to stop waterpipe smoking.<br>|
| Placebo Comparator: Placebo<br>76 participants will be assigned to 4 behavioral therapy cessation for smoking cessation and will be randomized to receive a Placebo for Varinecline with instructions for administration for 12 weeks starting 1 week before Smoking Quit Date as suggested by the manufacturer: Days 1 to 3: a placebo (matched to 0.5 mg of Varenicline) orally once a day Days 4 to 7: a placebo (matched to 0.5 mg of Varenicline) orally twice a day Days 8 to end of treatment: a placebo (matched to 1 mg of Varenicline) orally twice a day. Intervention 'Placebo (for Varenicline)' and Intervention 'Behavioral Therapy' | Drug: Placebo (for Varenicline)<br>* A randomized double-blind placebo-controlled trial that will evaluate the effect of Varenicline (Chantix), in 2 parallel groups of habitual waterpipe smokers who are willing to quit (n=152). 76 subjects will be randomized to receive a varenicline-matched. The participants, study investigators and personnel who will be interviewing the participants and collecting the clinical data, will be blinded to the assigned treatment.<br>Behavioral: Behavioral Therapy<br>* This intervention is for all study participants and it involves 4 visits to the hospital. Each visit include a 30-min one-on-one individual session with the specialized therapist during which participants will be taught how to manage any withdrawal symptoms they experience, how to anticipate high-risk situations, deal with smoking triggers, achieve and maintain their goal to stop waterpipe smoking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged abstinence from waterpipe smoking at three months post-cessation | Percent of participants who achieved sustained abstinence after a two-weeks grace period from quit date until final follow-up. This outcome will be assessed by self-reports and measured exhaled Carbon Monoxide and urine cotinine levels. | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence prevalence | Percent of participants who achieved sustained abstinence since quit date until the final follow-up. This outcome will be assessed by self-reports and measured exhaled Carbon Monoxide and urine cotinine levels. | up to 3 months | 
| Seven-day point prevalence abstinence | Percent of subjects who had no waterpipe use during the seven-day preceding final follow-up. Outcome will be assessed by self-reports, exhaled Carbon Monoxide and urine cotinine levels. | Last 7 days before final visit | 
| Participants' adherence rate to the study procedures | Measured by the number of pills used and the number of behavioural therapy sessions attended. | up to 3 months | 
| Change in weight | Change in weight between enrolment (visit-1) and end of treatment (visit-4, 3 month after quit date). | Baseline and 3 months | 
| Change in blood pressure | Change in blood pressure between enrolment (visit-1) and end of treatment (visit-4, 3 month after quit date). | Baseline and 3 months | 
| Evaluation of the Behavioral intervention | Participant's perception of the appropriateness and usefulness of the acquired behavioral interventions assessed using a questionnaire at the end of treatment | Up to 3 months | 
| Severity of symptoms | severity of abstinence symptoms and/or side effects related to Varenicline (Chantix) measured using the Minnesota Nicotine Withdrawal Scale and Varenicline (Chantix) side effects questionnaire during each follow-up phone call and at visits 2, 3 and 4. | Every two weeks, up to 3 months | 
| Change in anxiety scores | measured by the Hopkins Symptoms Checklist-25 (HSCL-25)between enrollment (visit-1, 1 week before quit date) and end of treatment (visit-4). | Baseline and 3 months | 
| Change in depression scores | measured by the Hopkins Symptoms Checklist-25 (HSCL-25)between enrollment (visit-1, 1 week before quit date) and end of treatment (visit-4). | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Waterpipe smoking, Nicotine dependence, Smoking cessation, Varinecline, Chantix therapy, Behavioral therapy