Clinical trial NCT02575183: Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation
Official title: Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nicotine Dependence
Keywords: Waterpipe smoking
Nicotine dependence
Smoking cessation
Varinecline, Chantix therapy
Behavioral therapy
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2015-10-14
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prolonged abstinence from waterpipe smoking at three months post-cessation
timeFrame: up to 3 months
Secondary outcomes:
measure: Continuous abstinence prevalence
timeFrame: up to 3 months
measure: Seven-day point prevalence abstinence
timeFrame: Last 7 days before final visit
measure: Participants' adherence rate to the study procedures
timeFrame: up to 3 months
measure: Change in weight
timeFrame: Baseline and 3 months
measure: Change in blood pressure
timeFrame: Baseline and 3 months
measure: Evaluation of the Behavioral intervention
timeFrame: Up to 3 months
measure: Severity of symptoms
timeFrame: Every two weeks, up to 3 months
measure: Change in anxiety scores
timeFrame: Baseline and 3 months
measure: Change in depression scores
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
References: