Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

NCT ID: NCT02575183

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2021-03-01

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.

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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'

Group Type: EXPERIMENTAL

Varinecline (Chantix)

Intervention Type: DRUG

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 Therapy

Intervention Type: BEHAVIORAL

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

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'

Group Type: PLACEBO_COMPARATOR

Placebo (for Varenicline)

Intervention Type: DRUG

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 Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

American University of Beirut Medical Center

Beirut, , Lebanon

American University of Beirut Medical Center

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

WI195422

Identifier Type: -

Identifier Source: org_study_id