Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04015414
• Other study ID #: GRAND / MEF Zagreb - LPPHR2018
• Secondary ID: WI231434 IIR
• Status: Completed
• Phase: Phase 3
• Start date: July 14, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: October 2022
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: November 1, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
Croatia	University of Zagreb School of Medicine	Zagreb
Slovenia	University of Ljubljana School of Medicine	Ljubljana

Sponsors (4)

Lead Sponsor	Collaborator
University of Zagreb	Harvard Medical School (HMS and HSDM), University of Ljubljana School of Medicine, Slovenia, University of Zagreb School of Medicine

Countries where clinical trial is conducted

Croatia,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Seven day abstinence from tobacco country and practice	Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.	4-weeks following target quit date
Secondary	Seven day abstinence from tobacco	Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.	8-weeks following target quit date
Secondary	Seven day abstinence from tobacco	Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.	24-weeks following target quit date
Secondary	Seven day abstinence from tobacco	Repeated measures of proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco	4, 8, 12, and 24 weeks following target quit date
Secondary	Continuous smoking cessation	Proportion of patients who self-report continuous smoking cessation in the varenicline and cytisine groups (5 cigarettes allowed)	4, 8, 12, and 24 weeks following target quit date
Secondary	Medication adherence	Self report of adherence to assigned treatment protocol, including count of pills and stopping treatment (including reasons)	1, 2, 3, 4, 8, 12 weeks following target quit date
Secondary	Side effects	Self-report of any unintended sign, symptom, or other health-related issue that occurs during treatment with varenicline or cytisine	4, 8, 12, and 24 weeks following target quit date