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

OHSN-REB #20220696-01H

This investigator-led study, directed by Dr. Hassan Mir and his team at the University of Ottawa Heart Institute, evaluates the efficacy and safety of three pharmacotherapies 1) combination Nicotine Replacement Therapy (NRT), 2) cytisine, and 3) varenicline - within the CanQuit framework. The study aims to determine whether these treatments are non-inferior to one another for smoking cessation among adults enrolled through an insurance-based outreach program.

Background

Tobacco use remains a leading cause of preventable disease and premature death globally. The Ottawa Model for Smoking Cessation (OMSC), a structured, evidence-based program combining counselling and pharmacotherapy, has improved quit rates across over 500 healthcare settings in Canada. Building upon this model, CanQuit integrates free virtual counselling, follow-up, and medication delivery to support smokers across Canada, particularly those reached through Sun Life Assurance Company of Canada.

Study Overview

The CanQuit study includes two groups:

• Group 1 (Randomized Controlled Trial):
  1,500 participants will be randomized to receive one of three pharmacotherapies—combination NRT, cytisine, or varenicline—along with structured virtual counselling and follow-up.

• Group 2 (Observational Study):
  Participants who are ineligible or decline the RCT may enroll in a 6-month coaching and follow-up program without study-provided medication. They will be redirected to local cessation resources or providers for prescriptions if desired.

Intervention

Each participant receives a comprehensive intake assessment, personalized quit plan, and ongoing support through automated check-ins and live counselling.

• NRT Arm: Patch plus gum/lozenge for up to 26 weeks.

• Cytisine Arm: 3 mg three times daily for 12 weeks.

• Varenicline Arm: 1 mg twice daily for 12 weeks.
  All pharmacotherapies are titrated under supervision of a study physician and shipped directly through Lumino Health™ Pharmacy (Pillway).

Outcomes

Primary Outcome:
7-day point prevalence abstinence at 6 months (biochemically verified).

Secondary Outcomes:
Include 12-month abstinence, quit attempts, reduction in cigarette use, adherence to pharmacotherapy, counselling engagement, and participant satisfaction.

Recruitment & Follow-Up

Sun Life will distribute email invitations to clients nationwide, with interested participants screened and consented by the study team. All participants will receive automated TelASK follow-ups at multiple time points (days 3–180) and research visits at 1-, 3-, 6-, and 12-months. Cotinine verification will confirm abstinence.

Significance

This is among the first RCTs to directly compare combination NRT, cytisine, and varenicline. By evaluating pharmacotherapy within a fully virtual cessation model, this study will inform scalable, cost-effective strategies for national smoking cessation initiatives. The program also explores how quitting impacts insurance costs and public health outcomes, aligning with Canada’s 2035 target to reduce smoking prevalence below 5%.