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RECRUITING
NCT06832085
PHASE4

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

Sponsor: Ottawa Heart Institute Research Corporation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-04-30

Completion Date

2027-10-30

Last Updated

2026-03-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

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.

DRUG

Cytisine

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

DRUG

Varenicline (Champix)

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

Locations (1)

University of Ottawa Heart Institute

Ottawa, Ontario, Canada