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

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 Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Varenicline; Drug: Cytisine

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Phase 3

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • University of Zagreb School of Medicine
• Slovenia
  • Ljubljana, Slovenia, 1000
    • University of Ljubljana School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Varenicline (Champix); 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.	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; Other Names: Champix
Active Comparator: Cytisine (Tabex); 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.	Drug: Cytisine; 185 patients will receive cytisine for 25 days and regular phone calls with brief counseling; Other Names: Tabex

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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)	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)	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	4, 8, 12, and 24 weeks following target quit date

Collaborators and Investigators

• Sponsor: University of Zagreb
• Collaborators: Harvard Medical School (HMS and HSDM); University of Ljubljana School of Medicine, Slovenia; University of Zagreb School of Medicine
• Investigators: Principal Investigator: Stjepan Oreskovic, PhD, University of Zagreb School of Medicine; Principal Investigator: Sanja Percac Lima, PhD, MD, Massachusetts General Hospital; Study Chair: Hrvoje Tiljak, PhD, University of Zagreb School of Medicine; Study Chair: Janez Rifel, PhD, University of Ljubljana School of Medicine; Study Chair: Jeffrey M Ashbruner, PhD, MPH, Massachusetts General Hospital; Study Chair: Zalika Klemenc Ketis, MD, PhD, University of Ljubljana School of Medicine; Study Chair: Tin Oreskovic, IBM Chief Analytics Office, MIT-IBM AI Lab

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: GRAND / MEF Zagreb - LPPHR2018; WI231434 IIR (Other Grant/Funding Number: Pfizer Inc., a Delaware corporation with an office of business at 235 East 42nd Street, New York, NY 10017 ("Pfizer")

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: After completion of the data collection and analysis
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes