Combining nicotine replacement therapy and medications for quitting smoking
Official title: Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation: A Randomized Controlled Trial
Run by Ottawa Heart Institute Research Corporation · NCT06832085 · Data updated 2026-11-12
This study is testing whether smokers are willing to join a quit smoking program that combines counseling with different products to help them stop smoking over a year.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Status | Recruiting |
| Started | April 30, 2025 |
| Main results expected | April 30, 2027 |
| Study ends | October 30, 2027 |
| Registry record updated | March 5, 2026 |
| Trial ID | NCT06832085 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are current smokers, consuming more than 5 cigarettes per day, and interested in quitting within the next 6 months.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have contraindications to the study medications will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the willingness of smokers to participate in a quit smoking program that offers counseling and various tobacco cessation products over a 12-month period. Participants will receive one of three approved cessation products—combination nicotine replacement therapy, cytisine, or varenicline—along with virtual counseling and follow-up. The study aims to track the safety, usage, and adherence to these products, as well as the effectiveness of a virtual pharmacy delivering these products directly to participants. An observational group will also receive free virtual coaching and complete questionnaires without receiving study medications.
Why it matters
Potential benefit: If successful, this study could provide a comprehensive and effective approach to smoking cessation that is accessible and convenient for patients.
How similar studies have gone: This approach is novel, as there are no prior studies evaluating an entirely virtual smoking cessation intervention with direct-to-consumer delivery of pharmacotherapy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 or outcomes in the opinion of the study investigator (for example acutely unwell, life expectancy less than 1 year).
Where it's running
-
University of Ottawa Heart Institute
Ottawa, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Evyanne Quirouette
- Email: equirouette@ottawaheart.ca
- Phone: 613-696-7000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.