Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

Nicotine Dependence Clinical Trial

Official title:

Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575183
• Other study ID #: WI195422
• Status: Completed
• Phase: Phase 4
• Start date: August 31, 2016
• Est. completion date: March 1, 2021

Study information

• Verified date: September 2020
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	Pfizer

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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