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Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting

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ClinicalTrials.gov Identifier: NCT04015414
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : August 10, 2020
Sponsor:
Collaborators:
University of Ljubljana School of Medicine, Slovenia
University of Zagreb School of Medicine
Harvard Medical School
Information provided by (Responsible Party):
Stjepan Oreskovic, University of Zagreb

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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Varenicline Drug: Cytisine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Varenicline Versus Cytisine for Smoking Cessation in the Primary Care Setting in Croatia and Slovenia - a Randomized Controlled Trial
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


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
190 patients will receive varenicline for 12 weeks and regular phone calls with brief counseling Tabex: 190 patients will receive cytisine for 25 days and regular phone calls with brief counseling
Other Name: 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
190 patients will receive cytisine for 25 days and regular phone calls with brief counseling
Other Name: Tabex




Primary Outcome Measures :
  1. Seven day abstinence from tobacco [ Time Frame: 12-weeks following target quit date ]
    Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.


Secondary Outcome Measures :
  1. Seven day abstinence from tobacco country and practice [ Time Frame: 4-weeks following target quit date ]
    Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.

  2. Seven day abstinence from tobacco [ Time Frame: 8-weeks following target quit date ]
    Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.

  3. Seven day abstinence from tobacco [ Time Frame: 24-weeks following target quit date ]
    Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.

  4. Seven day abstinence from tobacco [ Time Frame: 4, 8, 12, and 24 weeks following target quit date ]
    Repeated measures of proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco

  5. Continuous smoking cessation [ Time Frame: 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)

  6. Medication adherence [ Time Frame: 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)

  7. Side effects [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015414


Contacts
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Contact: Stjepan Oreskovic, PhD +385912858247 sooreskov@gmail.com
Contact: Jeffrey M Ashburner, PhD 617/724-3828 jasburner@mgh.harvard.edu

Locations
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Croatia
University of Zagreb School of Medicine Recruiting
Zagreb, Croatia, 10000
Contact: Hrvoje Tiljak, MD, Phd    +38598232803    htiljak@gmail.com   
Slovenia
University of Ljubljana School of Medicine Recruiting
Ljubljana, Slovenia, 1000
Contact: Janez Rifel, MD, PhD    +38641648548    janez.rifel@gmail.com   
Sponsors and Collaborators
University of Zagreb
University of Ljubljana School of Medicine, Slovenia
University of Zagreb School of Medicine
Harvard Medical School
Investigators
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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
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Responsible Party: Stjepan Oreskovic, Full Professor, University of Zagreb
ClinicalTrials.gov Identifier: NCT04015414    
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" )
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After completion of the data collection and analysis

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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
Additional relevant MeSH terms:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs