Combination Nicotine Replacement Therapy + Cytisine + Varenicline for Tobacco Use
(Sun Life RCT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Ottawa Heart Institute Research Corporation

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this 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) over a 12-week treatment period. 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) among people who are already clients of Sun Life

Eligibility Criteria

This trial is for Sun Life clients who smoke and are interested in quitting. Participants will receive counseling and tobacco cessation products over a year, with a focus on the first 12 weeks. The study excludes individuals not meeting specific health criteria or those unable to commit to the program's duration.

Inclusion Criteria

I am 18 or older and a client of Sun Life Assurance Company of Canada.

Able to provide informed consent

Living in Ontario, Canada

+1 more

Exclusion Criteria

Pregnant or breastfeeding individuals

Actively enrolled in another formal smoking cessation program

Unable to engage in follow-up for any reason (for example an acute mental illness, cognitive impairment, unable to speak English or French)

+3 more

Participant Groups

The trial tests three smoking cessation methods: Cytisine, Nicotine Replacement Therapy (patch plus gum/lozenge), and Varenicline (Champix). It evaluates their effectiveness when combined with counseling and direct delivery from a virtual pharmacy over 12 weeks.

3Treatment groups

Active Control

Group I: Varenicline (Champix)Active Control1 Intervention

Varenicline - standard dose

Group II: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)Active Control1 Intervention

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

Group III: CytisineActive Control1 Intervention

Cytisine pills, standard dose