An interventional study of E-cigarette e-liquid and Cytisine in Tobacco Smoking, Harm Reduction and Nicotine, sponsored by Centre for Addiction and Mental Health. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment
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.
264 studies on the registry are indexed under Tobacco Smoking; 42 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 119 across 229 interventional studies indexed under Tobacco Smoking.
Browse Tobacco Smoking studies →Centre for Addiction and Mental Health is the lead sponsor of 339 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants treated with Cytisine for smoking cessation
Dietary Supplement: Cytisine
Participants treated with E-cigarettes for smoking cessation
Device: E-cigarette e-liquid
E-cigarette used as a smoking cessation intervention
Cytisine used as a smoking cessation intervention
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.
Time frame: From enrollment to the 12-month follow-up
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.
Time frame: From enrollment to the 12-month follow-up
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Jan 2028, 20 months later.
Of 112 non-industry interventional studies with no phase under Tobacco Smoking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 35. This study's planned 20 months is below that.
Counting every sponsor, half of 151 studies reached it within 16 months; a quarter within 4 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cytisine
Centre for Addiction and Mental Health →