Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

NCT02575183 | Completed Phase 4

• 1 other identifier: WI195422
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

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

Keywords

Waterpipe smoking; Nicotine dependence; Smoking cessation; Varinecline, Chantix therapy; Behavioral therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Continuous abstinence prevalence

  up to 3 months

• Seven-day point prevalence abstinence

  Last 7 days before final visit

• Participants' adherence rate to the study procedures

  up to 3 months

• Change in weight

  Baseline and 3 months

• Change in blood pressure

  Baseline and 3 months

Study Arms (2)

Varenicline (Chantix)

EXPERIMENTAL

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); Behavioral: Behavioral Therapy

Placebo

PLACEBO COMPARATOR

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'

Drug: Placebo (for Varenicline); Behavioral: Behavioral Therapy

Interventions

Varinecline (Chantix) 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.

Varenicline (Chantix)

Placebo (for Varenicline) 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.

Placebo

Behavioral Therapy 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; Varenicline (Chantix)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Daily waterpipe smokers from the community of Beirut,
• aged 18 years or older
• willing to quit

You may not qualify if:

• Cigarette and/or cigars smokers,
• active malignancy
• Pregnant women

Sponsors & Collaborators

• American University of Beirut Medical Center: lead
• Pfizer: collaborator

Study Sites (2)

American University of Beirut Medical Center

Beirut, 1107-2020, Lebanon

Location

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Water Pipe Smoking; Smoking Cessation

Interventions

Varenicline; Behavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pipe Smoking; Smoking; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: October 14, 2015
• Study Start: August 31, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 17, 2021

Record last verified: 2020-09

Locations

LE (2)