Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting

NCT04015414 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: GRAND / MEF Zagreb - LPPHR2018WI231434 IIR
• Study Type: interventional
• Target: 352
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Seven day abstinence from tobacco country and practice

  4-weeks following target quit date

• Seven day abstinence from tobacco

  8-weeks following target quit date

• Seven day abstinence from tobacco

  24-weeks following target quit date

• Seven day abstinence from tobacco

  4, 8, 12, and 24 weeks following target quit date

• Continuous smoking cessation

  4, 8, 12, and 24 weeks following target quit date

Study Arms (2)

Varenicline (Champix)

ACTIVE COMPARATOR

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

Cytisine (Tabex)

ACTIVE COMPARATOR

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

Interventions

Varenicline 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

Also known as: Champix

Varenicline (Champix)

Cytisine DRUG

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

Also known as: Tabex

Cytisine (Tabex)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Mental illness who cannot provide informed consent for the study
• Pregnant or breastfeeding.

Sponsors & Collaborators

• University of Zagreb: lead
• University of Ljubljana School of Medicine, Slovenia: collaborator
• University of Zagreb School of Medicine: collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (2)

University of Zagreb School of Medicine

Zagreb, 10000, Croatia

Location

University of Ljubljana School of Medicine

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline; cytisine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Stjepan Oreskovic, PhD

  University of Zagreb School of Medicine

  PRINCIPAL INVESTIGATOR

• Sanja Percac Lima, PhD, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 11, 2019
• Study Start: July 14, 2020
• Primary Completion: September 15, 2022
• Study Completion: November 1, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After completion of the data collection and analysis

Locations

CR (1); SL (1)