Smoking Harm Reduction Using E-cigarettes and Cytisine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre for Addiction and Mental Health
About this trial
Smoking remains the leading cause of preventable death globally, with high prevalence in disadvantaged populations despite access to free nicotine replacement therapy (NRT) and counseling through Ontario's STOP Program. This study aims to evaluate the acceptability, feasibility, and comparative effectiveness of e-cigarettes and cytisine as harm-reduction tools for individuals who continue to smoke despite standard treatments. Over four years, 6,000 STOP participants who smoke ≥5 cigarettes daily at six months post-treatment will be randomized to receive either an e-cigarette starter kit or a 28-day cytisine supply. Data will be collected via REDCap and include biomarkers (NNAL, PAH), self-reported smoking behavior, nicotine dependence, and quality of life. Statistical analyses will assess changes and compare outcomes between groups. Results will inform public health strategies and enhance equitable cessation support for underserved populations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willingness to comply with all study procedures, for the full duration of the study period (12 months);
Age 18 years or older;
Currently smoking 5 or more cigarettes daily; and
Must have regular access to a phone and email to receive study communications and complete study monitoring.
Disqualifiers
Individuals who smoke only occasionally or have quit smoking prior to the 6-month follow-up;
Daily or almost daily users of e-cigarettes for the past 30 days;
Presence of medical or psychiatric conditions that may interfere with safe participation or compliance with the study protocol, including severe cardiovascular disorders, renal impairment or respiratory conditions;
Known allergy or hypersensitivity to any components of the e-cigarettes, e-liquids, or cytisine;
Trial design
Design model
Parallel
Treatments tested in this trial
E-cigarette e-liquid
DeviceE-cigarette used as a smoking cessation intervention
Cytisine
Dietary supplementCytisine used as a smoking cessation intervention
Treatment groups
6,000 Participants
are divided into 2 treatment groupsGroup A: Cytisine groupActive comparator 1 intervention
Group B: E-cigarette groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Voucher redemption rates as measures of feasibility for e-cigarettes and cytisine
To test the feasibility of e-cigarettes and cytisine as alternatives to standard evidence-based treatment in a group of individuals who were unable to quit using standard evidence-based treatment of NRT and counselling.
Time frame
From enrollment to the 12-month follow-upSecondary outcomes
1
Effectiveness of e-cigarettes and cytisine for smoking cessation measured by change in cigarettes per day
The objective is to compare the effectiveness of e-cigarettes and cytisine. The main effectiveness outcome is change from baseline in cigarettes per day (CPD) at end of treatment. Researchers will dichotomize this variable to assess the proportion of participants in each group that achieve ≥ 50% reduction in CPD.
Time frame
From enrollment to the 12-month follow-upLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: