Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting

Phase 3

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Varenicline; Drug: Cytisine

• Registration Number: NCT04015414
• Lead Sponsor: University of Zagreb

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-11
• Study Start: 2020-07-14
• Primary Completion: 2022-09-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Study Completion: 2022-11-01
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline (Champix)	Varenicline	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.
Cytisine (Tabex)	Cytisine	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.

Primary Outcome Measures

Name	Time	Method
Seven day abstinence from tobacco	12-weeks following target quit date	Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.

Secondary Outcome Measures

Name	Time	Method
Seven day abstinence from tobacco	4, 8, 12, and 24 weeks following target quit date	Repeated measures of proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco
Continuous smoking cessation	4, 8, 12, and 24 weeks following target quit date	Proportion of patients who self-report continuous smoking cessation in the varenicline and cytisine groups (5 cigarettes allowed)
Medication adherence	1, 2, 3, 4, 8, 12 weeks following target quit date	Self report of adherence to assigned treatment protocol, including count of pills and stopping treatment (including reasons)
Seven day abstinence from tobacco country and practice	4-weeks following target quit date	Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.
Side effects	4, 8, 12, and 24 weeks following target quit date	Self-report of any unintended sign, symptom, or other health-related issue that occurs during treatment with varenicline or cytisine

Trial Locations

Locations (2)

University of Zagreb School of Medicine; 🇭🇷 Zagreb, Croatia

University of Ljubljana School of Medicine; 🇸🇮 Ljubljana, Slovenia