Tobacco SmokingSHRECCNCT07274475
Smoking Harm Reduction Using E-cigarettes and Cytisine
A study testing E-cigarette e-liquid and Cytisine in people with Tobacco Smoking and Harm Reduction, run by Centre for Addiction and Mental Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Smoking, Harm Reduction, Nicotine
- What is being tested?
- E-cigarette e-liquid and Cytisine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Tobacco Smoking, Harm Reduction, Nicotine
- Being tested
- E-cigarette e-liquid, Cytisine
- Keywords
- Cytisine, E-cigarettes, Smoking cessation, treatment-resistant, Addiction, Clinical intervention
- Medical subject headings
- Tobacco Smoking, Harm Reduction, Vaping, Smoking Cessation, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigarette e-liquidDevice
E-cigarette used as a smoking cessation intervention
CytisineDietary supplement
Cytisine used as a smoking cessation intervention
| Study group | Role | What they receive |
|---|---|---|
| Cytisine group | Active comparator | Participants treated with Cytisine for smoking cessation Receives: Dietary Supplement: Cytisine |
| E-cigarette group | Active comparator | Participants treated with E-cigarettes for smoking cessation Receives: Device: E-cigarette e-liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From enrollment to the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 May 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurie Zawertailo, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274475
- Sponsor's protocol ID
- 2025/040
- Other IDs
- 2425-HQ-000023
- Acronym
- SHRECC
- Status last verified
- Mar 2026
- First submitted
- 29 May 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Alternative Approaches to Harm Reduction and Cessation for Treatment-Resistant Tobacco Dependence
- ClinicalTrials.gov ID
- NCT07274475
- Acronym / sponsor ID
- SHRECC / 2025/040
- Conditions
- Tobacco Smoking, Harm Reduction, Nicotine
- Keywords
- Cytisine, E-cigarettes, Smoking cessation, treatment-resistant, Addiction, Clinical intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytisine group | Active comparator | Dietary Supplement: CytisineParticipants treated with Cytisine for smoking cessation |
| E-cigarette group | Active comparator | Device: E-cigarette e-liquidParticipants treated with E-cigarettes for smoking cessation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-cigarette e-liquidE-cigarette used as a smoking cessation intervention | Device | E-cigarette group |
| CytisineCytisine used as a smoking cessation intervention | Dietary supplement | Cytisine group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing E-cigarette e-liquid and Cytisine in people with Tobacco Smoking and Harm Reduction, run by Centre for Addiction and Mental Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie Zawertailo, Ph.D (416-5358501 ext. 77422, laurie.zawertailo@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voucher redemption rates as measures of feasibility for e-cigarettes and cytisine (time frame: From enrollment to the 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.