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Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

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ClinicalTrials.gov Identifier: NCT02575183
Recruitment Status : Recruiting
First Posted : October 14, 2015
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: Varinecline (Chantix) Drug: Placebo (for Varenicline) Behavioral: Behavioral Therapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation
Actual Study Start Date : August 31, 2016
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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'

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.

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.




Primary Outcome Measures :
  1. Prolonged abstinence from waterpipe smoking at three months post-cessation [ Time Frame: 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 :
  1. Continuous abstinence prevalence [ Time Frame: 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.

  2. Seven-day point prevalence abstinence [ Time Frame: 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.

  3. Participants' adherence rate to the study procedures [ Time Frame: up to 3 months ]
    Measured by the number of pills used and the number of behavioural therapy sessions attended.

  4. Change in weight [ Time Frame: Baseline and 3 months ]
    Change in weight between enrolment (visit-1) and end of treatment (visit-4, 3 month after quit date).

  5. Change in blood pressure [ Time Frame: Baseline and 3 months ]
    Change in blood pressure between enrolment (visit-1) and end of treatment (visit-4, 3 month after quit date).

  6. Evaluation of the Behavioral intervention [ Time Frame: 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

  7. Severity of symptoms [ Time Frame: 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.

  8. Change in anxiety scores [ Time Frame: 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).

  9. Change in depression scores [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575183


Contacts
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Contact: Hassan Chami, MD, MSc 961 1 374 374 ext 5303 hchami@aub.edu.lb

Locations
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Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon, 1107-2020
Contact: Hassan Chami, M.D    009611350000 ext 5303    hchami@aub.edu.lb   
Contact: Nour Houshaimi, M.D    009611350000 ext 5923    nourhoushaimi@gmail.com   
American University of Beirut Medical Center Not yet recruiting
Beirut, Lebanon
Contact: Hassan Chami, MD, MSc    961 1 374 374 ext 5303    hchami@aub.edu.lb   
Principal Investigator: Hassan Chami, MD, MSc         
Sub-Investigator: Farid Talih, MD         
Sub-Investigator: Monique Chaaya, Phd         
Sub-Investigator: Christine Weir Abbyad, Phd         
Sponsors and Collaborators
American University of Beirut Medical Center
Pfizer

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Responsible Party: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02575183     History of Changes
Other Study ID Numbers: WI195422
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Keywords provided by American University of Beirut Medical Center:
Waterpipe smoking
Nicotine dependence
Smoking cessation
Varinecline, Chantix therapy
Behavioral therapy

Additional relevant MeSH terms:
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Varenicline
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs