Combining nicotine replacement therapy and medications for quitting smoking
Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation: A Randomized Controlled Trial
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 |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06832085 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to the study medications will not benefit from this study.
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 performed: This approach is novel, as there are no prior studies evaluating an entirely virtual smoking cessation intervention with direct-to-consumer delivery of pharmacotherapy.
Eligibility criteria
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 this trial is running
Ottawa, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Evyanne Quirouette
- Email: equirouette@ottawaheart.ca
- Phone: 613-696-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.