NCT04015414

Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: University of Zagreb · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Varenicline	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
DRUG	Cytisine	185 patients will receive cytisine for 25 days and regular phone calls with brief counseling

Timeline

• Start date: 2020-07-14
• Primary completion: 2022-09-15
• Completion: 2022-11-01
• First posted: 2019-07-11
• Last updated: 2022-11-03

Locations

2 sites across 2 countries: Croatia, Slovenia

Regulatory

• FDA-regulated drug study