NCT06832085 Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation
| NCT ID | NCT06832085 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Tobacco |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2025-04-30 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06832085 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tobacco. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06832085 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06832085 currently recruiting?
Yes, NCT06832085 is actively recruiting participants. Contact the research team at equirouette@ottawaheart.ca for enrollment information.
Where is the NCT06832085 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06832085 clinical trial?
NCT06832085 is sponsored by Ottawa Heart Institute Research Corporation. The trial plans to enroll 150 participants.