Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting

NCT ID: NCT04015414

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-14
• Study Completion Date: 2022-11-01

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Cytisine

Intervention Type: DRUG

185 patients will receive cytisine for 25 days and regular phone calls with brief counseling

Interventions

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

Intervention Type: DRUG

Cytisine

185 patients will receive cytisine for 25 days and regular phone calls with brief counseling

Intervention Type: DRUG

Other Intervention Names

Champix; Tabex

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ljubljana School of Medicine, Slovenia

OTHER

Sponsor Role: collaborator

University of Zagreb School of Medicine

UNKNOWN

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

University of Zagreb

OTHER

Sponsor Role: lead

Responsible Party

Stjepan Oreskovic

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stjepan Oreskovic, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zagreb School of Medicine

Sanja Percac Lima, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Hrvoje Tiljak, PhD

Role: STUDY_CHAIR

University of Zagreb School of Medicine

Janez Rifel, PhD

Role: STUDY_CHAIR

University of Ljubljana School of Medicine

Jeffrey M Ashbruner, PhD, MPH

Role: STUDY_CHAIR

Massachusetts General Hospital

Zalika Klemenc Ketis, MD, PhD

Role: STUDY_CHAIR

University of Ljubljana School of Medicine

Tin Oreskovic

Role: STUDY_CHAIR

IBM Chief Analytics Office, MIT-IBM AI Lab

Locations

University of Zagreb School of Medicine

Zagreb, , Croatia

University of Ljubljana School of Medicine

Ljubljana, , Slovenia

Countries

Croatia; Slovenia

Other Identifiers

WI231434 IIR

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GRAND / MEF Zagreb - LPPHR2018

Identifier Type: -

Identifier Source: org_study_id