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NCT Number: NCT06832085

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

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.

Recruiting

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Key information

Conditions

Tobacco Behavior Health Behavior Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Drug

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

cytisine

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Participant's Smoking Status at follow-up

    Time frame: 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.

  2. Number of quit attempts made by participant

    Time frame: 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.

  3. Participant's level of nicotine dependance

    Time frame: 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.

  4. Participant's heaviness of smoking score

    Time frame: 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.

  5. Participant's adherence to the counselling program

    Time frame: 12 months

    Attendance will be recorded for each counselling visit and adherence will be totaled for each participant at the end of the study.

  6. Participant's adherence to study medication

    Time frame: 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.

  7. Participant's response to smoking cessation quality of life questionnaire

    Time frame: 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.

  8. Participant's response to the Patient Health Questionnaire (PHQ-9)

    Time frame: 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.

  9. Participant's response to the General Anxiety Disorder Questionnaire (GAD-7)

    Time frame: 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.

Other outcomes

  1. Participant recruitment metrics

    Time frame: 12 months

    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.

  2. Participant satisfaction metrics

    Time frame: 12 months

    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).

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • Pillway Health Pharmacy
  • Sun Life Assurance Company of Canada
  • Vita Aid Professional Therapeutics

Registry information

Official study title

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

Acronym: CanQuit RCT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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