Tobacco
Conditions
Keywords
Tobacco, Tobacco cessation, Nicotine, Nicotine replacement therapy, Cytisine, Varenicline, counselling
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.
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
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.
DRUGCytisine
Participants in this group will take 3mg of cytisine 3 times per day for 12 weeks.
Participants in this group will take 1mg of varenicline 2 times per day for 12 weeks.
Sponsors
Ottawa Heart Institute Research Corporation
Sun Life Assurance Company of Canada
Vita Aid Professional Therapeutics
Pillway Health Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant's Smoking Status | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant's Smoking Status at follow-up | 1, 3, and 12 months | 7-Day Point Prevalence of Smoking Cessation will be measured at each follow-up time point via survey. For those who report they have quit smoking, this will be biochemically verified through a salivary cotinine test. |
| Number of quit attempts made by participant | 6, and 12 months | Participants will be asked via survey at each follow-up visit if they have had a reduction in their cigarette consumption or made a quit attempt (defined as abstaining from tobacco for at least 24-hours). If they have made a quit attempt, they will be asked to report how many quit attempts they have made since the last follow-up visit. The total number of times the participant has refrained from using tobacco for at least 24-hours will be recorded. |
| Participant's level of nicotine dependance | 6, and 12 months | Participants will be asked via survey response to complete the Fagerstrom Test for Nicotine Dependence at each follow-up visit. The total score will be calculated and recorded for each time point. |
| Participant's adherence to the counselling program | 12 months | Attendance will be recorded for each counselling visit and adherence will be totaled for each participant at the end of the study. |
| Participant's adherence to study medication | 6 months | Adherence to the prescribed medication and regime will be collected for each participant via self-report. The number of weeks on treatment will be recorded along with the number of missed doses. |
| Participant's response to smoking cessation quality of life questionnaire | Baseline, 6 and 12 months | The tobacco specific SF-36 questionnaire will be administered at each follow-up visit. The total score will be recorded for each visit. |
| Participant's response to the Patient Health Questionnaire (PHQ-9) | Baseline, 6 and 12 months | The PHQ-9 will be administered at each follow-up visit. The score will be calculated and recorded for each participant. |
| Participant's heaviness of smoking score | 6, and 12 months | Participants will be asked via survey response to complete the Heaviness of Smoking Index (to record the current level of dependence) at each follow-up visit. The total score will be calculated and recorded for each time point. |
| Participant's response to the General Anxiety Disorder Questionnaire (GAD-7) | Baseline, 6 and 12 months | The GAD-7 will be administered at each follow-up visit. The score will be calculated and recorded for each participant. |
Countries
Canada
Contacts
CONTACTEvyanne Quirouette
CONTACTLeah Margetson
Outcome results
None listed