NCT07274475

Smoking Harm Reduction Using E-cigarettes and Cytisine

Exploring Alternative Approaches to Harm Reduction and Cessation for Treatment-Resistant Tobacco Dependence

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,000 (estimated)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tobacco Smoking
• Harm Reduction
• Nicotine

Interventions

Type	Name	Description
DEVICE	E-cigarette e-liquid	E-cigarette used as a smoking cessation intervention
DIETARY_SUPPLEMENT	Cytisine	Cytisine used as a smoking cessation intervention

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-01-01
• Completion: 2028-03-01
• First posted: 2025-12-10
• Last updated: 2026-03-19