Smoking Harm Reduction Using E-cigarettes and Cytisine

NCT07274475 | Not Yet Recruiting DMC

• 2 other identifiers: 2025/0402425-HQ-000023
• Study Type: interventional
• Target: 6,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cytisine; E-cigarettes; Smoking cessation; treatment-resistant; Addiction; Clinical intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  From enrollment to the 12-month follow-up

Study Arms (2)

Cytisine group

ACTIVE COMPARATOR

Participants treated with Cytisine for smoking cessation

Dietary Supplement: Cytisine

E-cigarette group

ACTIVE COMPARATOR

Participants treated with E-cigarettes for smoking cessation

Device: E-cigarette e-liquid

Interventions

E-cigarette e-liquid DEVICE

E-cigarette used as a smoking cessation intervention

E-cigarette group

Cytisine DIETARY_SUPPLEMENT

Cytisine used as a smoking cessation intervention

Cytisine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

MeSH Terms

Conditions

Tobacco Smoking; Harm Reduction; Vaping; Smoking Cessation; Behavior, Addictive

Interventions

cytisine

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Health Behavior; Compulsive Behavior; Impulsive Behavior

Central Study Contacts

Laurie Zawertailo, Ph.D

CONTACT

416-5358501; laurie.zawertailo@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: December 10, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share