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Completed

NCT Number: NCT04015414

Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Zagreb School of Medicine, Zagreb, Croatia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Champix

cytisine

Drug

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

Other names: Tabex

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • University of Ljubljana School of Medicine, Slovenia

Registry information

Official study title

Varenicline Versus Cytisine for Smoking Cessation in the Primary Care Setting in Croatia and Slovenia - a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2019
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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