Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation
NCT ID: NCT06832085
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1500 participants
INTERVENTIONAL
2025-04-30
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)
Nicotine replacement therapy patch (titrated based on cigarettes consumed at baseline) plus short term gum or lozenge (as needed)
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
Cytisine pills, standard dose
Cytisine
Participants in this group will take 3mg of cytisine 3 times per day for 12 weeks.
Varenicline (Champix)
Varenicline - standard dose
Varenicline (Champix)
Participants in this group will take 1mg of varenicline 2 times per day for 12 weeks.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
18 Years
ALL
No
Sponsors
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Sun Life Assurance Company of Canada
UNKNOWN
Vita Aid Professional Therapeutics
UNKNOWN
Lumino Health™ Pharmacy
UNKNOWN
Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
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Locations
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University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20240741-01H
Identifier Type: -
Identifier Source: org_study_id
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