Clinical trial NCT06832085: Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation
Official title: Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Tobacco
Keywords: Tobacco
Tobacco cessation
Nicotine
Nicotine replacement therapy
Cytisine
Varenicline
counselling
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Sun Life Assurance Company of Canada
name: Vita Aid Professional Therapeutics
name: Lumino Health™ Pharmacy
First posted: 2025-02-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Detailed description: This study will engage people who smoke through an insurance-based outreach program (Sun Life Assurance Company of Canada) to evaluate the efficacy and safety of three pharmacotherapy arms (combination NRT, cytisine, or varenicline) within the OMSC framework, which includes the provision of cost-free virtual counselling, follow-up, and direct-to-consumer delivery of medications.

To our knowledge, there are no prior studies evaluating an entirely virtual smoking cessation intervention which includes virtual counselling/follow-up and direct-to-consumer delivery of pharmacotherapy. 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. Beyond cost savings associated with smoking cessation, this study may also reduce insurance premiums for patients, thus leading to additional source of cost savings.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Participant's Smoking Status
timeFrame: 6 months
Secondary outcomes:
measure: Participant's Smoking Status at follow-up
timeFrame: 1, 3, and 12 months
measure: Number of quit attempts made by participant
timeFrame: 6, and 12 months
measure: Participant's level of nicotine dependance
timeFrame: 6, and 12 months
measure: Participant's heaviness of smoking score
timeFrame: 6, and 12 months
measure: Participant's adherence to the counselling program
timeFrame: 12 months
measure: Participant's adherence to study medication
timeFrame: 6 months
measure: Participant's response to smoking cessation quality of life questionnaire
timeFrame: Baseline, 6 and 12 months
measure: Participant's response to the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 6 and 12 months
measure: Participant's response to the General Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Baseline, 6 and 12 months
Other outcomes:
measure: Participant recruitment metrics
timeFrame: 12 months
measure: Participant satisfaction metrics
timeFrame: 12 months
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
References: