TobaccoPhase 4CanQuit RCTNCT06832085
Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation
A Phase 4 study testing Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge), Cytisine and Varenicline (Champix) in people with Tobacco, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco
- What is being tested?
- Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge), Cytisine and Varenicline (Champix)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 30 Apr 2025to 30 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Evyanne Quirouette, 613-696-7000 ext. 17596, equirouette@ottawaheart.ca
Leah Margetson, 613-696-7000 ext. 16114, lmargetson@ottawaheart.ca
About this study
Official title: 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.
Read the 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
- Being tested
- Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge), Cytisine, Varenicline (Champix)
- Keywords
- Tobacco, Tobacco cessation, Nicotine, Nicotine replacement therapy, Cytisine, Varenicline, counselling
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)Drug
Also called Nicotine Replacement Therapy gum, Nicotine Replacement Therapy 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.
CytisineDrug
Participants in this group will take 3mg of cytisine 3 times per day for 12 weeks.
Varenicline (Champix)Drug
Participants in this group will take 1mg of varenicline 2 times per day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge) | Active comparator | Nicotine replacement therapy patch (titrated based on cigarettes consumed at baseline) plus short term gum or lozenge (as needed) Receives: Drug: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge) |
| Cytisine | Active comparator | Cytisine pills, standard dose Receives: Drug: Cytisine |
| Varenicline (Champix) | Active comparator | Varenicline - standard dose Receives: Drug: Varenicline (Champix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (9)
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.
Measured: 1, 3, 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.
Measured: 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.
Measured: 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.
Measured: 6, 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start30 Apr 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TobaccoStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Life Assurance Company of Canada, Vita Aid Professional Therapeutics, Pillway Health Pharmacy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832085
- Sponsor's protocol ID
- 20240741-01H
- Acronym
- CanQuit RCT
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06832085
- Acronym / sponsor ID
- CanQuit RCT / 20240741-01H
- Conditions
- Tobacco
- Keywords
- Tobacco, Tobacco cessation, Nicotine, Nicotine replacement therapy, Cytisine, Varenicline, counselling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Sun Life Assurance Company of Canada, Vita Aid Professional Therapeutics, Pillway Health Pharmacy
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge) | Active comparator | Drug: 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 | Active comparator | Drug: CytisineCytisine pills, standard dose |
| Varenicline (Champix) | Active comparator | Drug: Varenicline (Champix)Varenicline - standard dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)Also: Nicotine Replacement Therapy gum, Nicotine Replacement Therapy lozengeParticipants 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 | Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge) |
| CytisineParticipants in this group will take 3mg of cytisine 3 times per day for 12 weeks. | Drug | Cytisine |
| Varenicline (Champix)Participants in this group will take 1mg of varenicline 2 times per day for 12 weeks. | Drug | Varenicline (Champix) |
Primary outcome
Participant's Smoking Status
Time frame: 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.
9 secondary outcomes
Participant's Smoking Status at follow-up
Time frame: 1, 3, and 12 months
Number of quit attempts made by participant
Time frame: 6, and 12 months
Participant's level of nicotine dependance
Time frame: 6, and 12 months
Participant's heaviness of smoking score
Time frame: 6, and 12 months
Participant's adherence to the counselling program
Time frame: 12 months
Participant's adherence to study medication
Time frame: 6 months
Participant's response to smoking cessation quality of life questionnaire
Time frame: Baseline, 6 and 12 months
Participant's response to the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 6 and 12 months
Participant's response to the General Anxiety Disorder Questionnaire (GAD-7)
Time frame: Baseline, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge), Cytisine and Varenicline (Champix) in people with Tobacco, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evyanne Quirouette (613-696-7000 ext. 17596, equirouette@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant's Smoking Status (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.