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NOT YET RECRUITING
NCT07274475
NA

Smoking Harm Reduction Using E-cigarettes and Cytisine

Sponsor: Centre for Addiction and Mental Health

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6000

Start Date

2026-05-01

Completion Date

2028-03

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DEVICE

E-cigarette e-liquid

E-cigarette used as a smoking cessation intervention

DIETARY_SUPPLEMENT

Cytisine

Cytisine used as a smoking cessation intervention