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

NCT06832085 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sun Life Assurance Company of Canada

    collaborator UNKNOWN

  • Vita Aid Professional Therapeutics

    collaborator UNKNOWN

  • Pillway Health Pharmacy

    collaborator UNKNOWN

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2027-04-30
Completion
2027-10-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06832085 on ClinicalTrials.gov