Smoking Cessation
Conditions
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.
Interventions
DRUGVarenicline
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
DRUGCytisine
185 patients will receive cytisine for 25 days and regular phone calls with brief counseling
Sponsors
University of Ljubljana School of Medicine, Slovenia
University of Zagreb School of Medicine
Harvard Medical School (HMS and HSDM)
University of Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Seven day abstinence from tobacco | 8-weeks following target quit date | 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) |
| 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 |
Countries
Croatia, Slovenia
Outcome results
None listed