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

NCT06832085 | Recruiting Phase 4 DMC

• 1 other identifier: 20240741-01H
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Participant's Smoking Status

  7-Day Point Prevalence of Smoking Cessation will be measured at 6 months. For those who report they have quit smoking, this will be biochemically verified through a salivary cotinine test.

  6 months

Secondary Outcomes (9)

• Participant's Smoking Status at follow-up

  1, 3, and 12 months

• Number of quit attempts made by participant

  6, and 12 months

• Participant's level of nicotine dependance

  6, and 12 months

• Participant's heaviness of smoking score

  6, and 12 months

• Participant's adherence to the counselling program

  12 months

Other Outcomes (2)

• Participant recruitment metrics

  12 months

• Participant satisfaction metrics

  12 months

Study Arms (3)

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

ACTIVE COMPARATOR

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

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

Cytisine

ACTIVE COMPARATOR

Cytisine pills, standard dose

Drug: Cytisine

Varenicline (Champix)

ACTIVE COMPARATOR

Varenicline - standard dose

Drug: Varenicline (Champix)

Interventions

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

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.

Also known as: Nicotine Replacement Therapy gum, Nicotine Replacement Therapy lozenge

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

Cytisine DRUG

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

Cytisine

Varenicline (Champix) DRUG

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

Varenicline (Champix)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Sun Life Assurance Company of Canada: collaborator
• Vita Aid Professional Therapeutics: collaborator
• Pillway Health Pharmacy: collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Nicotine Replacement Therapy; Tobacco Use Cessation Devices; cytisine; Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Central Study Contacts

Evyanne Quirouette

CONTACT

613-696-7000; equirouette@ottawaheart.ca

Leah Margetson

CONTACT

613-696-7000; lmargetson@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 18, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)