Clinical trial NCT04015414: Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting
Official title: Varenicline Versus Cytisine for Smoking Cessation in the Primary Care Setting in Croatia and Slovenia - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: University of Zagreb
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
name: University of Zagreb School of Medicine
name: Harvard Medical School (HMS and HSDM)
First posted: 2019-07-11
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Seven day abstinence from tobacco
timeFrame: 12-weeks following target quit date
Secondary outcomes:
measure: Seven day abstinence from tobacco country and practice
timeFrame: 4-weeks following target quit date
measure: Seven day abstinence from tobacco
timeFrame: 8-weeks following target quit date
measure: Seven day abstinence from tobacco
timeFrame: 24-weeks following target quit date
measure: Seven day abstinence from tobacco
timeFrame: 4, 8, 12, and 24 weeks following target quit date
measure: Continuous smoking cessation
timeFrame: 4, 8, 12, and 24 weeks following target quit date
measure: Medication adherence
timeFrame: 1, 2, 3, 4, 8, 12 weeks following target quit date
measure: Side effects
timeFrame: 4, 8, 12, and 24 weeks following target quit date
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University of Zagreb School of Medicine
city: Ljubljana
country: Slovenia
facility: University of Ljubljana School of Medicine
Study officials:
affiliation: University of Zagreb School of Medicine
name: Stjepan Oreskovic, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Sanja Percac Lima, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zagreb School of Medicine
name: Hrvoje Tiljak, PhD
role: STUDY_CHAIR
affiliation: University of Ljubljana School of Medicine
name: Janez Rifel, PhD
role: STUDY_CHAIR
affiliation: Massachusetts General Hospital
name: Jeffrey M Ashbruner, PhD, MPH
role: STUDY_CHAIR
affiliation: University of Ljubljana School of Medicine
name: Zalika Klemenc Ketis, MD, PhD
role: STUDY_CHAIR
affiliation: IBM Chief Analytics Office, MIT-IBM AI Lab
name: Tin Oreskovic
role: STUDY_CHAIR
References: