NCT Number: NCT06832085
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Ottawa, Ontario, K1Y 4W7, Canada
Location status: Recruiting
Evyanne Quirouette
CONTACT
613-696-7000 ext. 17596
Hassan Mir, MD
PRINCIPAL_INVESTIGATOR
Leah Margetson
CONTACT
613-696-7000 ext. 16114
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Nicotine Replacement Therapy gum, Nicotine Replacement Therapy lozenge
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Attendance will be recorded for each counselling visit and adherence will be totaled for each participant at the end of the study.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
The number of Sun Life clients emailed and the number of clients who click the link to self-refer to the program will be recorded by Sun Life and reported to the study team at the end of the study. This will be compared to the number of people screened and enrolled by the study team.
Time frame: 12 months
At the end of study participation, participants will be asked a series of satisfaction questions related to their counselling sessions (information provided, length and number of sessions etc) and medication delivery (instructions, actual delivery process etc).
Contact information is provided by the study sponsor or research team.
Ottawa Heart Institute Research Corporation
Other
Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation: A Randomized Controlled Trial
Acronym: CanQuit RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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