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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco
• Intervention / Treatment: Drug: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge); Drug: Cytisine; Drug: Varenicline (Champix)

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).

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Evyanne Quirouette; Phone Number: 17596 613-696-7000; Email: equirouette@ottawaheart.ca
• Study Contact Backup: Name: Leah Margetson; Phone Number: 16114 613-696-7000; Email: lmargetson@ottawaheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Recruiting
      • University of Ottawa Heart Institute
      • Principal Investigator: Hassan Mir, MD
      • Contact: Evyanne Quirouette; Phone Number: 17596 613-696-7000; Email: equirouette@ottawaheart.ca
      • Contact: Leah Margetson; Phone Number: 16114 613-696-7000; Email: lmargetson@ottawaheart.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge); Nicotine replacement therapy patch (titrated based on cigarettes consumed at baseline) plus short term gum or lozenge (as needed)	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.; Other Names: Nicotine Replacement Therapy gum; Nicotine Replacement Therapy lozenge
Active Comparator: Cytisine; Cytisine pills, standard dose	Drug: Cytisine; Participants in this group will take 3mg of cytisine 3 times per day for 12 weeks.
Active Comparator: Varenicline (Champix); Varenicline - standard dose	Drug: Varenicline (Champix); Participants in this group will take 1mg of varenicline 2 times per day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant's Smoking Status	7-Day Point Prevalence of Smoking Cessation will be measured at 6 months. For those who report they have quit smoking, this will be biochemically verified through a salivary cotinine test.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant's Smoking Status at follow-up	7-Day Point Prevalence of Smoking Cessation will be measured at each follow-up time point via survey. For those who report they have quit smoking, this will be biochemically verified through a salivary cotinine test.	1, 3, and 12 months
Participant's adherence to the counselling program	Attendance will be recorded for each counselling visit and adherence will be totaled for each participant at the end of the study.	12 months
Participant's adherence to study medication	Adherence to the prescribed medication and regime will be collected for each participant via self-report. The number of weeks on treatment will be recorded along with the number of missed doses.	6 months
Participant's response to smoking cessation quality of life questionnaire	The tobacco specific SF-36 questionnaire will be administered at each follow-up visit. The total score will be recorded for each visit.	Baseline, 6 and 12 months
Participant's response to the Patient Health Questionnaire (PHQ-9)	The PHQ-9 will be administered at each follow-up visit. The score will be calculated and recorded for each participant.	Baseline, 6 and 12 months
Participant's response to the General Anxiety Disorder Questionnaire (GAD-7)	The GAD-7 will be administered at each follow-up visit. The score will be calculated and recorded for each participant.	Baseline, 6 and 12 months
Number of quit attempts made by participant	Participants will be asked via survey at each follow-up visit if they have had a reduction in their cigarette consumption or made a quit attempt (defined as abstaining from tobacco for at least 24-hours). If they have made a quit attempt, they will be asked to report how many quit attempts they have made since the last follow-up visit. The total number of times the participant has refrained from using tobacco for at least 24-hours will be recorded.	6, and 12 months
Participant's level of nicotine dependance	Participants will be asked via survey response to complete the Fagerstrom Test for Nicotine Dependence at each follow-up visit. The total score will be calculated and recorded for each time point.	6, and 12 months
Participant's heaviness of smoking score	Participants will be asked via survey response to complete the Heaviness of Smoking Index (to record the current level of dependence) at each follow-up visit. The total score will be calculated and recorded for each time point.	6, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant recruitment metrics	The number of Sun Life clients emailed and the number of clients who click the link to self-refer to the program will be recorded by Sun Life and reported to the study team at the end of the study. This will be compared to the number of people screened and enrolled by the study team.	12 months
Participant satisfaction metrics	At the end of study participation, participants will be asked a series of satisfaction questions related to their counselling sessions (information provided, length and number of sessions etc) and medication delivery (instructions, actual delivery process etc).	12 months

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Collaborators: Sun Life Assurance Company of Canada; Vita Aid Professional Therapeutics; Pillway Health Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Tobacco; Nicotine; Varenicline; Tobacco cessation; counselling; Nicotine replacement therapy; Cytisine
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Tobacco Use Cessation; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Drug Therapy; Benzazepines; Quinoxalines; Varenicline; Tobacco Use Cessation Devices; Nicotine Replacement Therapy; cytisine
• Other Study ID Numbers: 20240741-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No