Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge), Cytisine, Varenicline (Champix).
- Who it may be relevant to
- Registry conditions: Tobacco. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation: A Randomized Controlled Trial
Overview
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.
Detailed description
This vanguard 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.
The goal is to recruit a minimum of 150 participants for this Vanguard phase. If successful, recruitment will continue until the budget is finished, or, until additional funding is received to support a full-scale trial (N=1650 participants).
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.
Primary outcome measures
- Participant's Smoking Status [Time frame: 6 months]
Secondary outcome measures (9)
- Participant's Smoking Status at follow-up [Time frame: 1, 3, and 12 months]
- Number of quit attempts made by participant [Time frame: 6, and 12 months]
- Participant's level of nicotine dependance [Time frame: 6, and 12 months]
- Participant's heaviness of smoking score [Time frame: 6, and 12 months]
- Participant's adherence to the counselling program [Time frame: 12 months]
- Participant's adherence to study medication [Time frame: 6 months]
- Participant's response to smoking cessation quality of life questionnaire [Time frame: Baseline, 6 and 12 months]
- Participant's response to the Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, 6 and 12 months]
- Participant's response to the General Anxiety Disorder Questionnaire (GAD-7) [Time frame: Baseline, 6 and 12 months]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- University of Ottawa Heart Institute — Ottawa
Identifiers
NCT: NCT06832085 · 20240741-01H