Smoking Harm Reduction Using E-cigarettes and Cytisine (SHRECC)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Smoking; Harm Reduction; Nicotine
• Intervention / Treatment: Dietary supplement: Cytisine; Device: E-cigarette e-liquid

• Study Type: Interventional
• Enrollment (Estimated): 6000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurie Zawertailo, Ph.D; Phone Number: 77422 416-5358501; Email: laurie.zawertailo@camh.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Willingness to comply with all study procedures, for the full duration of the study period (12 months);
2. Age 18 years or older;
3. Currently smoking 5 or more cigarettes daily; and
4. Must have regular access to a phone and email to receive study communications and complete study monitoring.

Exclusion Criteria:

1. Individuals who smoke only occasionally or have quit smoking prior to the 6-month follow-up;
2. Daily or almost daily users of e-cigarettes for the past 30 days;
3. 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;
4. Known allergy or hypersensitivity to any components of the e-cigarettes, e-liquids, or cytisine;
5. Pregnant or breastfeeding, or planning to become pregnant within the next 12 months; or
6. Current use of pharmacological smoking cessation aids or participation in other smoking cessation clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cytisine group; Participants treated with Cytisine for smoking cessation	Dietary supplement: Cytisine; Cytisine used as a smoking cessation intervention
Active Comparator: E-cigarette group; Participants treated with E-cigarettes for smoking cessation	Device: E-cigarette e-liquid; E-cigarette used as a smoking cessation intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the 12-month follow-up

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: May 29, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Smoking cessation; Addiction; treatment-resistant; E-cigarettes; Clinical intervention; Cytisine
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior; Smoking; Health Behavior; Tobacco Use; Behavior, Addictive; Vaping; Smoking Cessation; Tobacco Smoking; Harm Reduction; cytisine
• Other Study ID Numbers: 2025/040; 2425-HQ-000023 (Other Grant/Funding Number: Health Canada)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No