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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
352
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
185 patients will receive cytisine for 25 days and regular phone calls with brief counseling
University of Zagreb School of Medicine
Zagreb, Croatia
University of Ljubljana School of Medicine
Ljubljana, Slovenia
Seven day abstinence from tobacco
Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.
Time frame: 12-weeks following target quit date
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 4, 8, 12, and 24 weeks following target quit date
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