Smoking CessationPhase 4NCT02634281
Extended (6-Week) Varenicline Preloading: Does it Facilitate Smoking Reduction and Cessation?
A Phase 4 study testing Varenicline in people with Smoking Cessation, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
SUMMARY Rationale: Worldwide, cigarette smoking carries a high mortality. Since the available cessation programs are not effective for all smokers, new strategies are necessary for tobacco control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Varenicline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2016to 28 Jun 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women aged ≥18 years
- Currently smoking 10 cigarettes per day or more
- Having smoked 5 py or more
- Presenting a CO level in expired air ≥ 10 ppm
- Personally motivated to reduce or stop smoking and indicating a willingness to follow through with protocol requirements
- Willing to sign a statement of informed consent
Who cannot join
- Myocardial infarction within the last 3 months
- Unstable angina
- Severe cardiac arrhythmia
- Pregnancy or breast feeding
- Use of any form of smokeless tobacco or nicotine substitution
- Having followed any smoking cessation programme during the last 3 months
Show all 10Show fewer
- Alcohol or other drug addiction
- Use of any form of smokeless tobacco or nicotine substitution
- Participation in any clinical trial within the past 3 months
- Women in childbearing age not willing to use contraception until week 12 after QD
Trial locations and contacts
1 site in 1 country.
About this study
SUMMARY Rationale: Worldwide, cigarette smoking carries a high mortality. Since the available cessation programs are not effective for all smokers, new strategies are necessary for tobacco control.
Primary objective: To investigate whether a 6-week varenicline preloading facilitates smoking reduction and cessation compared with the standard varenicline treatment schedule.
Read more
Design: Parallel group, double-blind, randomised controlled clinical trial. Participants: Smokers of both sexes from the general population. Methods: Participants will be randomized into two groups of treatment. Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment. Visits will be arranged at randomization, week 4, week 6 (Quit day (QD)) and at week 1, 6, 12, and 24 after QD.
Measurements: These will include vital signs, smoking history, spirometry, expired CO, salivary cotinine, nicotine dependence, and withdrawal symptoms. Primary outcome is continuous abstinence at 6 months.
Sample size: For an estimated difference of quit rates of 15% at 24 weeks (30% for group A vs. 15% for group B) 121 subjects per group are needed (Total = 242 subjects).
Statistical analysis: T tests (rational variables) and x2 test or Fisher's exact test (nominal variables) will be used as appropriate.
Expected benefits: This study might contribute to optimize the current use of varenicline.
Read the detailed description
Study design:
The study is a parallel group, double-blind, randomised controlled clinical trial. Allocation to treatment will be made when the subject has been entered into the study that is when he/she has fulfilled the inclusion/exclusion criteria (see below). Visits will be arranged at inclusion, at week 4 and 6 (Quit day (QD)) after inclusion, and at week 1, 6, 12, and 24 after QD.
Study population:
Participants will be eligible smokers from throughout Jerusalem, who want to reduce then stop smoking.
Randomisation procedure:
Subjects will be computer-randomised either to an extended varenicline preload treatment or to a regular varenicline schedule. Both groups will receive an identical treatment thereafter.
Blinding:
Due to the nature of the intervention, blinding is possible only during the varenicline preload phase. During this phase, both the study team members and the participants will be blinded to treatment allocation. After week 6 all participants will be receiving the same, active treatment.
Study intervention:
After enrolment the subjects will be randomized to receive either varenicline preloading for 6 weeks (1 mg/day at week 1; 2 mg/day from week 2-6) (Group A) or placebo for 5 weeks and varenicline for 1 week (Group B). Then, subjects in both groups will receive regular treatment with varenicline for 12 weeks according to a schedule depicted on Table 2. Only minimal levels of advice and support will be given. However, all subjects will receive individualized verbal instructions regarding the general conduct of the study and the proper use of the study medication. All participants will be asked to reduce smoking by 50 percent during 6 weeks after inclusion then stop smoking altogether.
At baseline the following data will be collected:
- Demographic assessment (age, sex, height and weight). Subjects will be weighed during all scheduled visits on the same scale throughout the study: prior to weighing, subjects will remove shoes and excess clothes.
- Medical history
- Physical examination
- Vital signs (pulse, blood-pressure) will be assessed in the standard manner.
- Spirometry: This will be carried out at baseline and end-study using an electronic spirometer and techniques currently performed at the Pulmonary Institute, Shaare Zedek Medical Center.
- Smoking history and other smoking related information using the modified Cigarette Evaluation Questionnaire (mCEQ) .
- Nicotine dependence evaluation using the Fagerström Test for Nicotine Dependence (FTND) .
- CO in expired air. Expired carbon monoxide levels will be measured with a Bedfont monitor and recorded at each scheduled study visit. The subjects will be instructed to inhale deeply, do a 15 second breath hold, and produce a full, slow forced expiration through the disposable mouthpiece of the inflow valve of the monitor. Readings will be recorded in parts per million (ppm) of CO (non smokers = < 8 ppm ; smokers = > 10 to 75 ppm) .
- Withdrawal symptoms: Will be measured using the Mood Symptoms Physical Scale (MPPS) (See Appendix) .
- Salive Cotinine determinations: This will be carried out at 3 visits namely baseline visit, week 6 and end-trial.
- Concomitant medication: Information about currently used medication will be collected
- Conditions
- Smoking Cessation
- Being tested
- Varenicline, placebo
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called champix, chantix
Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment
placeboDrug
Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Subjects in Group A will receive varenicline for six weeks .During this phase, subjects will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment Receives: Drug: Varenicline |
| group B | Active comparator | group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment Receives: Drug: Varenicline; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous abstinence
defined as avoidance of tobacco (not a single puff) since the quit date. It will be assessed by self-reported complete abstinence and expired CO < 10 ppm from week 7 until endpoint. The occurrence of occasional lapses after week 7 will be categorised as a failure in the main evaluation, but will not necessitate withdrawal if the subject is willing to continue and is considered by the investigators as competent to succeed.
Measured: from week 7 until week 24
Secondary outcomes (5)
smoking reduction
This will be measured by daily self-reported cigarettes per day and expired CO measures (at every visit). An efficient reduction will be defined by a diminution of at least 50% of the number of cigarettes smoked, together with a reduction in CO levels compared to baseline
Measured: from week 7 until week 24
Decline in pulmonary function
The rate of decline of spirometric parameters will be calculated separately for quitters, continuing smokers and reducers from the two groups, pooled together.
Measured: from week 7 until week 24
adverse events
The subjects will be asked about adverse events at each visit during treatment by an open-ended question. Serious adverse events are defined as events that are fatal or life threatening, permanently disabling, requiring or prolonging hospitalisation, cancer, congenital abnormality or overdose
Measured: from week 7 until week 24
Symptoms and physical signs associated with withdrawal: MPSS questionnaire
MPSS questionnaire
Measured: from week 7 until week 24
Use of cigarettes
For participants smoking at any time point the number of cigarettes smoked per day and the satisfaction (mCEQ questionnaire) will be assessed.
Measured: from week 7 until week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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, Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abraham BOHADANA, MD, Principal investigator, Shaare zedek medical center, pulmonary institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634281
- Sponsor's protocol ID
- 0239-15-SZMC
- Status last verified
- Apr 2019
- First submitted
- 1 Dec 2015
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Bohadana A, Freier-Dror Y, Peles V, Babai P, Izbicki G. Extending varenicline preloading to 6 weeks facilitates smoking cessation: A single-site, randomised controlled trial. EClinicalMedicine. 2020 Feb 3;19:100228. doi: 10.1016/j.eclinm.2019.11.021. eCollection 2020 Feb.
PubMed 32055787
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended (6-Week) Varenicline Preloading: Does it Facilitate Smoking Reduction and Cessation?
- ClinicalTrials.gov ID
- NCT02634281
- Acronym / sponsor ID
- 0239-15-SZMC
- Conditions
- Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 18 Dec 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.
SUMMARY Rationale: Worldwide, cigarette smoking carries a high mortality. Since the available cessation programs are not effective for all smokers, new strategies are necessary for tobacco control.
Primary objective: To investigate whether a 6-week varenicline preloading facilitates smoking reduction and cessation compared with the standard varenicline treatment schedule.
Design: Parallel group, double-blind, randomised controlled clinical trial. Participants: Smokers of both sexes from the general population. Methods: Participants will be randomized into two groups of treatment. Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment. Visits will be arranged at randomization, week 4, week 6 (Quit day (QD)) and at week 1, 6, 12, and 24 after QD.
Measurements: These will include vital signs, smoking history, spirometry, expired CO, salivary cotinine, nicotine dependence, and withdrawal symptoms. Primary outcome is continuous abstinence at 6 months.
Sample size: For an estimated difference of quit rates of 15% at 24 weeks (30% for group A vs. 15% for group B) 121 subjects per group are needed (Total = 242 subjects).
Statistical analysis: T tests (rational variables) and x2 test or Fisher's exact test (nominal variables) will be used as appropriate.
Expected benefits: This study might contribute to optimize the current use of varenicline.
Detailed description
Study design:
The study is a parallel group, double-blind, randomised controlled clinical trial. Allocation to treatment will be made when the subject has been entered into the study that is when he/she has fulfilled the inclusion/exclusion criteria (see below). Visits will be arranged at inclusion, at week 4 and 6 (Quit day (QD)) after inclusion, and at week 1, 6, 12, and 24 after QD.
Study population:
Participants will be eligible smokers from throughout Jerusalem, who want to reduce then stop smoking.
Randomisation procedure:
Subjects will be computer-randomised either to an extended varenicline preload treatment or to a regular varenicline schedule. Both groups will receive an identical treatment thereafter.
Blinding:
Due to the nature of the intervention, blinding is possible only during the varenicline preload phase. During this phase, both the study team members and the participants will be blinded to treatment allocation. After week 6 all participants will be receiving the same, active treatment.
Study intervention:
After enrolment the subjects will be randomized to receive either varenicline preloading for 6 weeks (1 mg/day at week 1; 2 mg/day from week 2-6) (Group A) or placebo for 5 weeks and varenicline for 1 week (Group B). Then, subjects in both groups will receive regular treatment with varenicline for 12 weeks according to a schedule depicted on Table 2. Only minimal levels of advice and support will be given. However, all subjects will receive individualized verbal instructions regarding the general conduct of the study and the proper use of the study medication. All participants will be asked to reduce smoking by 50 percent during 6 weeks after inclusion then stop smoking altogether.
At baseline the following data will be collected:
- Demographic assessment (age, sex, height and weight). Subjects will be weighed during all scheduled visits on the same scale throughout the study: prior to weighing, subjects will remove shoes and excess clothes.
- Medical history
- Physical examination
- Vital signs (pulse, blood-pressure) will be assessed in the standard manner.
- Spirometry: This will be carried out at baseline and end-study using an electronic spirometer and techniques currently performed at the Pulmonary Institute, Shaare Zedek Medical Center.
- Smoking history and other smoking related information using the modified Cigarette Evaluation Questionnaire (mCEQ) .
- Nicotine dependence evaluation using the Fagerström Test for Nicotine Dependence (FTND) .
- CO in expired air. Expired carbon monoxide levels will be measured with a Bedfont monitor and recorded at each scheduled study visit. The subjects will be instructed to inhale deeply, do a 15 second breath hold, and produce a full, slow forced expiration through the disposable mouthpiece of the inflow valve of the monitor. Readings will be recorded in parts per million (ppm) of CO (non smokers = < 8 ppm ; smokers = > 10 to 75 ppm) .
- Withdrawal symptoms: Will be measured using the Mood Symptoms Physical Scale (MPPS) (See Appendix) .
- Salive Cotinine determinations: This will be carried out at 3 visits namely baseline visit, week 6 and end-trial.
- Concomitant medication: Information about currently used medication will be collected
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: VareniclineSubjects in Group A will receive varenicline for six weeks .During this phase, subjects will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment |
| group B | Active comparator | Drug: Varenicline, Drug: placebogroup B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women aged ≥18 years
- Currently smoking 10 cigarettes per day or more
- Having smoked 5 py or more
- Presenting a CO level in expired air ≥ 10 ppm
- Personally motivated to reduce or stop smoking and indicating a willingness to follow through with protocol requirements
Key exclusion criteria (10 listed)
- Myocardial infarction within the last 3 months
- Unstable angina
- Severe cardiac arrhythmia
- Pregnancy or breast feeding
- Use of any form of smokeless tobacco or nicotine substitution
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 |
|---|---|---|
| VareniclineAlso: champix, chantixSubjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment | Drug | group A, group B |
| placeboSubjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment | Drug | group B |
Primary outcome
Continuous abstinence
Time frame: from week 7 until week 24
defined as avoidance of tobacco (not a single puff) since the quit date. It will be assessed by self-reported complete abstinence and expired CO < 10 ppm from week 7 until endpoint. The occurrence of occasional lapses after week 7 will be categorised as a failure in the main evaluation, but will not necessitate withdrawal if the subject is willing to continue and is considered by the investigators as competent to succeed.
5 secondary outcomes
smoking reduction
Time frame: from week 7 until week 24
Decline in pulmonary function
Time frame: from week 7 until week 24
adverse events
Time frame: from week 7 until week 24
Symptoms and physical signs associated with withdrawal: MPSS questionnaire
Time frame: from week 7 until week 24
Use of cigarettes
Time frame: from week 7 until week 24
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 5 Oct 2021.
- Derived from this study: PubMed 32055787Bohadana A, Freier-Dror Y, Peles V, Babai P, Izbicki G. Extending varenicline preloading to 6 weeks facilitates smoking cessation: A single-site, randomised controlled trial. EClinicalMedicine. 2020 Feb 3;19:100228. doi: 10.1016/j.eclinm.2019.11.021. eCollection 2020 Feb.
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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.
Abraham BOHADANA, MD principal investigator
Shaare zedek medical center, pulmonary institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline in people with Smoking Cessation, run by Shaare Zedek Medical Center at 1 site in Israel.
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 6 inclusion and 10 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. 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?
Continuous abstinence (time frame: from week 7 until week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02634281, which also lists 1 linked publication.
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 5 Oct 2021.