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

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

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 goal is to recruit a minimum of 150 participants for this Vanguard phase.

It had three arms (groups): Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge) (active comparator), Cytisine (active comparator) and Varenicline (Champix) (active comparator).

Nicotine replacement therapy patch (titrated based on cigarettes consumed at baseline) plus short term gum or lozenge (as needed).

The registry classes the interventions as drug.

More on the Plan

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.

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 Took Part

The registry lists 150 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults (≥18 years). Able to provide informed consent.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2025-04-30 with completion listed for 2027-04-30.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Participant's Smoking Status (time frame: 6 months).

It also tracked 9 secondary outcomes, for example Participant's Smoking Status at follow-up, Number of quit attempts made by participant, Participant's level of nicotine dependance, Participant's heaviness of smoking score, Participant's adherence to the counselling program and Participant's adherence to study medication.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 150 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.