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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)
Drug
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.
Cytisine
Drug
Participants in this group will take 3mg of cytisine 3 times per day for 12 weeks.
Varenicline (Champix)
Drug
Participants in this group will take 1mg of varenicline 2 times per day for 12 weeks.

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)Active comparator 1 intervention

Group B: CytisineActive comparator 1 intervention

Group C: Varenicline (Champix)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Participant's Smoking Status

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

6 months

Secondary outcomes

Participant's Smoking Status at follow-up

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

1, 3, and 12 months

Number of quit attempts made by participant

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

Participant's level of nicotine dependance

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

Participant's heaviness of smoking score

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

6, and 12 months

Other outcomes

Participant recruitment metrics

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

Participant satisfaction metrics

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).

Time frame

12 months