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

Phase 4

Recruiting

• Conditions: Tobacco
• Interventions: Drug: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge); Drug: Cytisine; Drug: Varenicline (Champix)

• Registration Number: NCT06832085
• Lead Sponsor: Ottawa Heart Institute Research Corporation

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-18
• Study Start: 2025-04-30
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-08
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)	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)
Cytisine	Cytisine	Cytisine pills, standard dose
Varenicline (Champix)	Varenicline (Champix)	Varenicline - standard dose

Primary Outcome Measures

Name	Time	Method
Participant's Smoking Status	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Participant's response to the Patient Health Questionnaire (PHQ-9)	Baseline, 6 and 12 months	The PHQ-9 will be administered at each follow-up visit. The score will be calculated and recorded for each participant.
Participant's response to the General Anxiety Disorder Questionnaire (GAD-7)	Baseline, 6 and 12 months	The GAD-7 will be administered at each follow-up visit. The score will be calculated and recorded for each participant.
Participant's Smoking Status at follow-up	1, 3, and 12 months	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.
Number of quit attempts made by participant	6, and 12 months	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.
Participant's level of nicotine dependance	6, and 12 months	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.
Participant's heaviness of smoking score	6, and 12 months	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.
Participant's adherence to the counselling program	12 months	Attendance will be recorded for each counselling visit and adherence will be totaled for each participant at the end of the study.
Participant's adherence to study medication	6 months	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.
Participant's response to smoking cessation quality of life questionnaire	Baseline, 6 and 12 months	The tobacco specific SF-36 questionnaire will be administered at each follow-up visit. The total score will be recorded for each visit.

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada