NCT06832085

Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation

Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation: A Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This vanguard study will engage people who smoke through an insurance-based outreach program (Sun Life Assurance Company of Canada) to evaluate the efficacy and safety of three pharmacotherapy arms (combination NRT, cytisine, or varenicline) within the OMSC framework, which includes the provision of cost-free virtual counselling, follow-up, and direct-to-consumer delivery of medications. 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. The goal is to recruit a minimum of 150 participants for this Vanguard phase. If successful, recruitment will continue until the budget is finished, or, until additional funding is received to support a full-scale trial (N=1650 participants).

Conditions

• Tobacco

Interventions

Type	Name	Description
DRUG	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.
DRUG	Cytisine	Participants in this group will take 3mg of cytisine 3 times per day for 12 weeks.
DRUG	Varenicline (Champix)	Participants in this group will take 1mg of varenicline 2 times per day for 12 weeks.

Timeline

• Start date: 2025-04-30
• Primary completion: 2027-04-30
• Completion: 2027-10-30
• First posted: 2025-02-18
• Last updated: 2026-03-05

Locations

1 site across 1 country: Canada