Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation
Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation: A Randomized Controlled Trial
Ottawa Heart Institute Research Corporation
150 participants
Apr 30, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Adults (≥18 years)
- Current cigarette smokers (more than 5 cigarettes per day) who are interested in reducing or quitting in the next 6 months.
- Able to provide informed consent.
- Living in Ontario, Canada
Exclusion Criteria6
- 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 or outcomes in the opinion of the study investigator (for example acutely unwell, life expectancy less than 1 year).
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Interventions
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.
Participants in this group will take 3mg of cytisine 3 times per day for 12 weeks.
Participants in this group will take 1mg of varenicline 2 times per day for 12 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06832085