Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting

Study Overview
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Brief Summary
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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.

Official Title
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Varenicline Versus Cytisine for Smoking Cessation in the Primary Care Setting in Croatia and Slovenia - a Randomized Controlled Trial

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Varenicline
* Drug: Cytisine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Mental illness who cannot provide informed consent for the study Pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Varenicline (Champix)<br>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. | Drug: Varenicline<br>* 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<br>* Other names: Champix;|
| Active Comparator: Cytisine (Tabex)<br>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. | Drug: Cytisine<br>* 185 patients will receive cytisine for 25 days and regular phone calls with brief counseling<br>* Other names: Tabex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seven day abstinence from tobacco | Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco. | 12-weeks following target quit date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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) | 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) | 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 | 4, 8, 12, and 24 weeks following target quit date |