Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Nicotine Dependence
• Intervention / Treatment: Drug: Varinecline (Chantix); Behavioral: Behavioral Therapy; Drug: Placebo (for Varenicline)

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center
  • Beirut, Lebanon, 1107-2020
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varenicline (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'	Drug: Varinecline (Chantix); 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.; Behavioral: Behavioral Therapy; 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.
Placebo Comparator: Placebo; 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'	Behavioral: Behavioral Therapy; 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.; Drug: Placebo (for Varenicline); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Collaborators: Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2016
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Smoking cessation; Nicotine dependence; Waterpipe smoking; Varinecline, Chantix therapy; Behavioral therapy
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: WI195422