Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation (Sun Life RCT)

University of Ottawa Heart Institute

Status and phase: Enrolling; Phase 4

Conditions: Tobacco

Treatments: Drug: Varenicline (Champix); Drug: Cytisine; Drug: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)

Study type: Interventional

Funder types: Other

Identifiers

NCT06832085

20240741-01H

Details and patient eligibility

About

The purpose of this 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) over a 12-week treatment period.

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.

Full description

This 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,500 participants in 3 patient groups

Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)

Active Comparator group

Description:

Nicotine replacement therapy patch (titrated based on cigarettes consumed at baseline) plus short term gum or lozenge (as needed)

Treatment:

Drug: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)

Cytisine

Active Comparator group

Description:

Cytisine pills, standard dose

Treatment:

Drug: Cytisine

Varenicline (Champix)

Active Comparator group

Description:

Varenicline - standard dose

Treatment:

Drug: Varenicline (Champix)