Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting

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

Interventions

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

DRUG

Cytisine

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

Sponsors & Collaborators

• University of Ljubljana School of Medicine, Slovenia

  collaborator OTHER

• University of Zagreb School of Medicine

  collaborator UNKNOWN

• Harvard Medical School (HMS and HSDM)

  collaborator OTHER

• University of Zagreb

  lead OTHER

Principal Investigators

• Stjepan Oreskovic, PhD · University of Zagreb School of Medicine

• Sanja Percac Lima, PhD, MD · Massachusetts General Hospital

• Hrvoje Tiljak, PhD · University of Zagreb School of Medicine

• Janez Rifel, PhD · University of Ljubljana School of Medicine

• Jeffrey M Ashbruner, PhD, MPH · Massachusetts General Hospital

• Zalika Klemenc Ketis, MD, PhD · University of Ljubljana School of Medicine

• Tin Oreskovic · IBM Chief Analytics Office, MIT-IBM AI Lab

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-14

Primary Completion

2022-09-15

Completion

2022-11-01

FDA Drug

Yes

Countries

• Croatia
• Slovenia

Study Locations