Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting

University of Zagreb

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Drug: Cytisine; Drug: Varenicline

Study type: Interventional

Funder types: Other

Identifiers

NCT04015414

WI231434 IIR (Other Grant/Funding Number)

GRAND / MEF Zagreb - LPPHR2018

Details and patient eligibility

About

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.

Enrollment: 352 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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352 participants in 2 patient groups

Varenicline (Champix)

Active Comparator group

Description:

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.

Treatment:

Drug: Varenicline

Cytisine (Tabex)

Active Comparator group

Description:

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.

Treatment:

Drug: Cytisine