Smoking Harm Reduction Using E-cigarettes and Cytisine

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.

NCT Number	NCT07274475
Lead Sponsor	Centre for Addiction and Mental Health
Conditions	Tobacco Smoking, Harm Reduction, Nicotine
Enrollment	6,000 participants
Start Date	2026-05-01
Primary Completion	2028-01 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-03-19