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NCT Number: NCT07274475

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.

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Key information

Conditions

Tobacco Smoking Behavior Behavior, Addictive Compulsive Behavior Harm Reduction Health Behavior Impulsive Behavior Nicotine Smoking Smoking Cessation Tobacco Use Vaping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Pregnant or breastfeeding, or planning to become pregnant within the next 12 months; or
  • Current use of pharmacological smoking cessation aids or participation in other smoking cessation clinical trials.

Treatment and study plan

E-cigarette e-liquid

Device

E-cigarette used as a smoking cessation intervention

Cytisine

Dietary Supplement

Cytisine used as a smoking cessation intervention

Primary outcomes

  1. Voucher redemption rates as measures of feasibility for e-cigarettes and cytisine

    Time frame: From enrollment to the 12-month follow-up

    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.

Secondary outcomes

  1. Effectiveness of e-cigarettes and cytisine for smoking cessation measured by change in cigarettes per day

    Time frame: From enrollment to the 12-month follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurie Zawertailo, Ph.D

CONTACT

[email protected]

416-5358501 ext. 77422

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

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

Acronym: SHRECC

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 10, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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