Nicotine DependencePhase 4NCT02575183
Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation
A Phase 4 study testing Varinecline (Chantix) and Behavioral Therapy in people with Nicotine Dependence, run by American University of Beirut Medical Center at 2 sites in Lebanon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Varinecline (Chantix) and Behavioral Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 2 sitesLebanon
- Study dates
- 31 Aug 2016to 1 Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Daily waterpipe smokers from the community of Beirut,
- aged 18 years or older
- willing to quit
Who cannot join
- Cigarette and/or cigars smokers,
- active malignancy
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
Lebanon2 sites
American University of Beirut Medical Center
Beirut, 1107-2020
American University of Beirut Medical Center
Beirut
About this study
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
- Being tested
- Varinecline (Chantix), Placebo (for Varenicline), Behavioral Therapy
- Keywords
- Waterpipe smoking, Nicotine dependence, Smoking cessation, Varinecline, Chantix therapy, Behavioral therapy
- Medical subject headings
- Tobacco Use Disorder, Water Pipe Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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' Receives: 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' Receives: Drug: Placebo (for Varenicline); Behavioral: Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study start31 Aug 2016
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575183
- Sponsor's protocol ID
- WI195422
- Status last verified
- Sep 2020
- First submitted
- 25 Mar 2015
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation
- ClinicalTrials.gov ID
- NCT02575183
- Acronym / sponsor ID
- WI195422
- Conditions
- Nicotine Dependence
- Keywords
- Waterpipe smoking, Nicotine dependence, Smoking cessation, Varinecline, Chantix therapy, Behavioral therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline (Chantix) | Experimental | Drug: Varinecline (Chantix), Behavioral: Behavioral Therapy76 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' |
| Placebo | Placebo comparator | Drug: Placebo (for Varenicline), Behavioral: Behavioral Therapy76 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' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Daily waterpipe smokers from the community of Beirut,
- aged 18 years or older
- willing to quit
Key exclusion criteria (3 listed)
- Cigarette and/or cigars smokers,
- active malignancy
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Varenicline (Chantix) |
| 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. | Drug | Placebo |
| Behavioral TherapyThis 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. | Behavioural | Placebo, Varenicline (Chantix) |
Primary outcome
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.
9 secondary outcomes
Continuous abstinence prevalence
Time frame: up to 3 months
Seven-day point prevalence abstinence
Time frame: Last 7 days before final visit
Participants' adherence rate to the study procedures
Time frame: up to 3 months
Change in weight
Time frame: Baseline and 3 months
Change in blood pressure
Time frame: Baseline and 3 months
Evaluation of the Behavioral intervention
Time frame: Up to 3 months
Severity of symptoms
Time frame: Every two weeks, up to 3 months
Change in anxiety scores
Time frame: Baseline and 3 months
Change in depression scores
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
Related trials for Nicotine Dependence
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varinecline (Chantix) and Behavioral Therapy in people with Nicotine Dependence, run by American University of Beirut Medical Center at 2 sites in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged abstinence from waterpipe smoking at three months post-cessation (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.