Recruiting

Nicotine Replacement Therapy, Cytisine, Varenicline

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT06832085

Conditions

Tobacco

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Cytisine

Varenicline (Champix)

Study Details

Brief 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. 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.

Conditions

Tobacco

Study ID

NCT06832085

Start date

Apr 30, 2025

Status verified date

Feb, 2026

Completion date

Oct 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

active comparator: Cytisine

Cytisine pills, standard dose

active comparator: Varenicline (Champix)

Varenicline - standard dose

Interventions

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.

Cytisine

Participants in this group will take 3mg of cytisine 3 times per day for 12 weeks.

Varenicline (Champix)

Participants in this group will take 1mg of varenicline 2 times per day for 12 weeks.

Primary outcome measure

  • Participant's Smoking Status [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Evyanne Quirouette

613-696-7000equirouette@ottawaheart.ca

Leah Margetson

613-696-7000lmargetson@ottawaheart.ca

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

Evyanne Quirouette

613-696-7000equirouette@ottawaheart.ca

Leah Margetson

613-696-7000lmargetson@ottawaheart.ca

Principal Investigator:

Hassan Mir, MD

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Mar 5, 2026

Last verified

Feb, 2026

Keywords

  • Tobacco
  • Tobacco cessation
  • Nicotine
  • Nicotine replacement therapy
  • Cytisine
  • Varenicline
  • counselling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-03-05.