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Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation
Sponsor: Ottawa Heart Institute Research Corporation
Summary
The purpose of this vanguard 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). The goal is to recruit a minimum of 150 participants for this Vanguard phase. 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.
Official title: Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-04-30
Completion Date
2027-10-30
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)
Participants in this group will apply 1 NRT patch each morning for up to 26 weeks. Patches will be titrated based on cigarettes consumed. Short-acting NRT products (gum and lozenge) will be used as needed by the participants in this group.
Cytisine
Participants in this group will take 3mg of cytisine 3 times per day for 12 weeks.
Varenicline (Champix)
Participants in this group will take 1mg of varenicline 2 times per day for 12 weeks.
Locations (1)
University of Ottawa Heart Institute
Ottawa, Ontario, Canada