Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation
- Conditions
- Nicotine Dependence
- Interventions
- Drug: Varinecline (Chantix)Drug: Placebo (for Varenicline)Behavioral: Behavioral Therapy
- Registration Number
- NCT02575183
- Lead Sponsor
- American University of Beirut Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
- Daily waterpipe smokers from the community of Beirut,
- aged 18 years or older
- willing to quit
- Cigarette and/or cigars smokers,
- active malignancy
- Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Varenicline (Chantix) Varinecline (Chantix) 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' Varenicline (Chantix) Behavioral Therapy 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' Placebo Behavioral Therapy 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' Placebo Placebo (for Varenicline) 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'
- Primary Outcome Measures
Name Time Method Prolonged abstinence from waterpipe smoking at three months post-cessation up to 3 months 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.
- Secondary Outcome Measures
Name Time Method Change in blood pressure Baseline and 3 months Change in blood pressure between enrolment (visit-1) and end of treatment (visit-4, 3 month after quit date).
Evaluation of the Behavioral intervention Up to 3 months Participant's perception of the appropriateness and usefulness of the acquired behavioral interventions assessed using a questionnaire at the end of treatment
Continuous abstinence prevalence up to 3 months 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.
Change in weight Baseline and 3 months Change in weight between enrolment (visit-1) and end of treatment (visit-4, 3 month after quit date).
Change in depression scores Baseline and 3 months measured by the "Hopkins Symptoms Checklist-25 (HSCL-25)"between enrollment (visit-1, 1 week before quit date) and end of treatment (visit-4).
Seven-day point prevalence abstinence Last 7 days before final visit 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.
Participants' adherence rate to the study procedures up to 3 months Measured by the number of pills used and the number of behavioural therapy sessions attended.
Severity of symptoms Every two weeks, up to 3 months 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.
Change in anxiety scores Baseline and 3 months measured by the "Hopkins Symptoms Checklist-25 (HSCL-25)"between enrollment (visit-1, 1 week before quit date) and end of treatment (visit-4).
Trial Locations
- Locations (1)
American University of Beirut Medical Center
🇱🇧Beirut, Lebanon