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

ConditionTobacco
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)
  • Cytisine
  • Varenicline (Champix)

Treatment groups

150 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Ottawa Heart Institute Research Corporation

Lead sponsor

Sun Life Assurance Company of Canada

Collaborator

Vita Aid Professional Therapeutics

Collaborator

Pillway Health Pharmacy

Collaborator