Smoking CessationPhase 3NCT04015414
Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting
A Phase 3 study testing Varenicline and Cytisine in people with Smoking Cessation, run by University of Zagreb at 2 sites in 2 countries.
Trial summary
The overall goals of this study are to 1) assess awareness of interest in the use of pharmacotherapy for smoking cessation in Croatia and Slovenia, countries in Central Europe with very high smoking prevalence, and 2) investigate whether cytisine is at least as feasible and effective as varenicline in helping smokers… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Varenicline and Cytisine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Jul 2020to 1 Nov 2022
- Phase
- Phase 3
- 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
- Receive care in one of forty family medicine practices in Croatia and Slovenia
- Aged 18 or older
- Current smokers
- Indicate a desire to stop smoking and to use pharmacotherapy.
Who cannot join
- Mental illness who cannot provide informed consent for the study
- Pregnant or breastfeeding.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Varenicline Versus Cytisine for Smoking Cessation in the Primary Care Setting in Croatia and Slovenia - a Randomized Controlled Trial
The overall goals of this study are to 1) assess awareness of interest in the use of pharmacotherapy for smoking cessation in Croatia and Slovenia, countries in Central Europe with very high smoking prevalence, and 2) investigate whether cytisine is at least as feasible and effective as varenicline in helping smokers to quit in a real-life setting: family medicine practices in Croatia and Slovenia. The investigators propose to survey patients from 40 primary care practices (20 in Croatia and 20 in Slovenia) to assess desire to quit smoking and awareness and interest in pharmacotherapy. Additionally, 380 patients with interest in quitting smoking will be randomly assigned to use varenicline or cytisine to help quit smoking.
The investigators hypothesize that cytisine is at least as feasible and effective as varenicline in helping smokers from primary care practices in Croatia and Slovenia to quit smoking.
- Conditions
- Smoking Cessation
- Being tested
- Varenicline, Cytisine
- 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
191 patients will receive varenicline for 12 weeks and regular phone calls with brief counseling Tabex: 188 patients will receive cytisine for 25 days and regular phone calls with brief counseling
CytisineDrug
Also called Tabex
185 patients will receive cytisine for 25 days and regular phone calls with brief counseling
| Study group | Role | What they receive |
|---|---|---|
| Varenicline (Champix) | Active comparator | Varenicline treatment will start one week prior to the patient's target quit date at 0.5 mg/day for days 1-3, 0.5 mg twice daily for days 4-7. On the target quit date (day 8), the dose will be increased to 1 mg twice daily and maintained for day 8-week 12. Patients will receive weekly calls during the first 4 weeks and at weeks 8, 12, and 24 to inquire about medication adherence and smoking status, motivate the patient to take the medication, encourage them not to smoke, and ask about possible side effects or other issues. Receives: Drug: Varenicline |
| Cytisine (Tabex) | Active comparator | Patients will be asked to reduce their smoking during the first 4 days of treatment with aim to quit on the 5th day (target quit date). Cytisine treatment will follow standard manufacturer's dosing protocol of one tablet every 2 hours through the waking day (up to 6 tablets per day) for days 1-3, one tablet every 2.5 hours (up to 5 tablets per day) for days 4-12, one tablet every 3 hours (up to 4 tablets per day) for days 13-16, one tablet every 4-5 hours (3 tablets per day) for days 17-20, and one tablet every 6 hours (2 tablets per day) for days 21-25. Receives: Drug: Cytisine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seven day abstinence from tobacco
Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.
Measured: 12-weeks following target quit date
Secondary outcomes (7)
Seven day abstinence from tobacco country and practice
Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.
Measured: 4-weeks following target quit date
Seven day abstinence from tobacco
Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.
Measured: 8-weeks following target quit date
Seven day abstinence from tobacco
Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.
Measured: 24-weeks following target quit date
Seven day abstinence from tobacco
Repeated measures of proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco
Measured: 4, 8, 12, and 24 weeks following target quit date
Continuous smoking cessation
Proportion of patients who self-report continuous smoking cessation in the varenicline and cytisine groups (5 cigarettes allowed)
Measured: 4, 8, 12, and 24 weeks following target quit date
Medication adherence
Self report of adherence to assigned treatment protocol, including count of pills and stopping treatment (including reasons)
Measured: 1, 2, 3, 4, 8, 12 weeks following target quit date
Side effects
Self-report of any unintended sign, symptom, or other health-related issue that occurs during treatment with varenicline or cytisine
Measured: 4, 8, 12, and 24 weeks following target quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start14 Jul 2020
- Primary completion15 Sep 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Stjepan Oreskovic, University of Zagreb
- Investigators
- Stjepan Oreskovic, PhD, Principal investigator, University of ZagrebSanja Percac Lima, PhD, MD, Principal investigator, Massachusetts General HospitalHrvoje Tiljak, PhD, Study chair, University of ZagrebJanez Rifel, PhD, Study chair, University of Ljubljana School of MedicineJeffrey M Ashbruner, PhD, MPH, Study chair, Massachusetts General HospitalZalika Klemenc Ketis, MD, PhD, Study chair, University of Ljubljana School of MedicineTin Oreskovic, Study chair, IBM Chief Analytics Office, MIT-IBM AI Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015414
- Sponsor's protocol ID
- GRAND / MEF Zagreb - LPPHR2018
- Other IDs
- WI231434 IIR
- Status last verified
- Oct 2022
- First submitted
- 2 Jul 2019
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline Versus Cytisine for Smoking Cessation in the Primary Care Setting in Croatia and Slovenia - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04015414
- Acronym / sponsor ID
- GRAND / MEF Zagreb - LPPHR2018
- Conditions
- Smoking Cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia, Harvard Medical School (HMS and HSDM)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 11 Jul 2019 (actual)
- 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 overall goals of this study are to 1) assess awareness of interest in the use of pharmacotherapy for smoking cessation in Croatia and Slovenia, countries in Central Europe with very high smoking prevalence, and 2) investigate whether cytisine is at least as feasible and effective as varenicline in helping smokers to quit in a real-life setting: family medicine practices in Croatia and Slovenia. The investigators propose to survey patients from 40 primary care practices (20 in Croatia and 20 in Slovenia) to assess desire to quit smoking and awareness and interest in pharmacotherapy. Additionally, 380 patients with interest in quitting smoking will be randomly assigned to use varenicline or cytisine to help quit smoking.
The investigators hypothesize that cytisine is at least as feasible and effective as varenicline in helping smokers from primary care practices in Croatia and Slovenia to quit smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline (Champix) | Active comparator | Drug: VareniclineVarenicline treatment will start one week prior to the patient's target quit date at 0.5 mg/day for days 1-3, 0.5 mg twice daily for days 4-7. On the target quit date (day 8), the dose will be increased to 1 mg twice daily and maintained for day 8-week 12. Patients will receive weekly calls during the first 4 weeks and at weeks 8, 12, and 24 to inquire about medication adherence and smoking status, motivate the patient to take the medication, encourage them not to smoke, and ask about possible side effects or other issues. |
| Cytisine (Tabex) | Active comparator | Drug: CytisinePatients will be asked to reduce their smoking during the first 4 days of treatment with aim to quit on the 5th day (target quit date). Cytisine treatment will follow standard manufacturer's dosing protocol of one tablet every 2 hours through the waking day (up to 6 tablets per day) for days 1-3, one tablet every 2.5 hours (up to 5 tablets per day) for days 4-12, one tablet every 3 hours (up to 4 tablets per day) for days 13-16, one tablet every 4-5 hours (3 tablets per day) for days 17-20, and one tablet every 6 hours (2 tablets per day) for days 21-25. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receive care in one of forty family medicine practices in Croatia and Slovenia
- Aged 18 or older
- Current smokers
- Indicate a desire to stop smoking and to use pharmacotherapy.
Key exclusion criteria (2 listed)
- Mental illness who cannot provide informed consent for the study
- Pregnant or breastfeeding.
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: Champix191 patients will receive varenicline for 12 weeks and regular phone calls with brief counseling Tabex: 188 patients will receive cytisine for 25 days and regular phone calls with brief counseling | Drug | Varenicline (Champix) |
| CytisineAlso: Tabex185 patients will receive cytisine for 25 days and regular phone calls with brief counseling | Drug | Cytisine (Tabex) |
Primary outcome
Seven day abstinence from tobacco
Time frame: 12-weeks following target quit date
Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.
7 secondary outcomes
Seven day abstinence from tobacco country and practice
Time frame: 4-weeks following target quit date
Seven day abstinence from tobacco
Time frame: 8-weeks following target quit date
Seven day abstinence from tobacco
Time frame: 24-weeks following target quit date
Seven day abstinence from tobacco
Time frame: 4, 8, 12, and 24 weeks following target quit date
Continuous smoking cessation
Time frame: 4, 8, 12, and 24 weeks following target quit date
Medication adherence
Time frame: 1, 2, 3, 4, 8, 12 weeks following target quit date
Side effects
Time frame: 4, 8, 12, and 24 weeks following target quit date
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 3 Nov 2022.
- Individual participant dataSharing planned: Yes
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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.
Stjepan Oreskovic, PhD principal investigator
University of Zagreb
Sanja Percac Lima, PhD, MD principal investigator
Massachusetts General Hospital
Hrvoje Tiljak, PhD study chair
University of Zagreb
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Varenicline and Cytisine in people with Smoking Cessation, run by University of Zagreb at 2 sites in 2 countries.
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 4 inclusion and 2 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 3 Nov 2022. 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 Croatia, Slovenia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Seven day abstinence from tobacco (time frame: 12-weeks following target quit date). 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 3 Nov 2022.