Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation

Phase

Condition

N/A

Treatment

Cytisine

Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)

Varenicline (Champix)

Clinical Study ID

NCT06832085

20240741-01H

Ages > 18
All Genders

Study Summary

The purpose of this trial is to test whether clients of Sun Life are willing to join in a quit smoking program that offers counselling and tobacco cessation products to all participants over a 12-month period. The study team will track the safety and usage of 3 types of cessation products as well as the effectiveness of a virtual pharmacy (i.e. cessation products delivered to participants directly from a pharmacy) over a 12-week treatment period.

The purpose of this study is to look at 3 approved smoking cessation products used in combination with counselling and virtual delivery of the smoking cessation products. The goal is to track product usage, safety, and adherence (how much of the products people use and how many counselling sessions they complete).

Within the study there will also be an observational group who will not receive study medication but who will receive free virtual coaching and follow-up for smoking cessation and complete study questionnaires.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adults (≥18 years)
Current cigarette smokers (more than 5 cigarettes per day) who are interested inreducing or quitting in the next 6 months.
Able to provide informed consent.
Living in Ontario, Canada

Exclusion

Exclusion Criteria:

Contraindications to any of the study medications (NRT, cytisine, varenicline).
Actively using one of the study medications in the past 7 days.
Actively enrolled in another formal smoking cessation program.
Pregnant or breastfeeding individuals.
Unable to engage in follow-up for any reason (for example an acute mental illness,cognitive impairment, unable to speak English or French).
Other conditions deemed by the study team to interfere with participation oroutcomes in the opinion of the study investigator (for example acutely unwell, lifeexpectancy less than 1 year).

Study Design

Cytisine

April 30, 2025

December 31, 2026

Study Description

This study will engage people who smoke through an insurance-based outreach program (Sun Life Assurance Company of Canada) to evaluate the efficacy and safety of three pharmacotherapy arms (combination NRT, cytisine, or varenicline) within the OMSC framework, which includes the provision of cost-free virtual counselling, follow-up, and direct-to-consumer delivery of medications.

To our knowledge, there are no prior studies evaluating an entirely virtual smoking cessation intervention which includes virtual counselling/follow-up and direct-to-consumer delivery of pharmacotherapy. This study will also engage the broader community setting, such as clients or employees of industry partners, represents a valuable opportunity to reach a wider population of people who smoke with tailored support. Beyond cost savings associated with smoking cessation, this study may also reduce insurance premiums for patients, thus leading to additional source of cost savings.

Connect with a study center

University of Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7
Canada
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.