Study Summary
This trial is testing an intervention to help smokers quit in order to improve long-term abstinence and health outcomes. The intervention includes a behavioural incentive and tailored follow-up support.
Eligible Conditions
- Cigarette Addiction
- Nicotine Withdrawal
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: 26 weeks (6 months) after study enrollment
Month 6
Smoking Abstinence
Week 104
Cessation Medication and/or E-cigarette Use
Health Services Outcomes - Deaths
Health Services Outcomes - ED visits
Health Services Outcomes - Hospital Admissions
Number of Quit Attempts
Prolonged Abstinence
Smoking Reduction
Use of Behavioural Supports
Week 104
Point Prevalence Abstinence
Week 104
Cost-Effectiveness Ratios
Health-Related Quality of Life
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Usual Care (UC)
1 of 2
Quit Card Intervention (QCI)
1 of 2
Active Control
Experimental Treatment
1208 Total Participants · 2 Treatment Groups
Primary Treatment: Quit Card Intervention (QCI) · No Placebo Group · N/A
Quit Card Intervention (QCI)
Behavioral
Experimental Group · 1 Intervention: Quit Card Intervention (QCI) · Intervention Types: BehavioralUsual Care (UC)NoIntervention Group · 1 Intervention: Usual Care (UC) · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 26 weeks (6 months) after study enrollment
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
179 Previous Clinical Trials
86,624 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,233 Previous Clinical Trials
24,675,444 Total Patients Enrolled
Kerri-Anne Mullen, PhDPrincipal InvestigatorOttawa Heart Institute Research Corporation
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are assigned a CTAS level of 2-5 (emergent to non-urgent).
You are a resident of Ontario and eligible for Ontario Health Insurance Plan (to permit linkage with administrative data housed at the Institute for Clinical Evaluative Sciences [ICES]).
You are a current daily smoker.
You are willing and able to participate in follow-up assessments over the next 24 months.
References
- Mullen, Kerri A., Aditi Garg, Frederick Gagnon, George Wells, Atul Kapur, Steven Hawken, Andrew L. Pipe, et al.. 2021. “The INITIATE Trial Protocol: A Randomized Controlled Trial Testing the Effectiveness of a “quit Card” Intervention on Long-term Abstinence Among Tobacco Smokers Presenting to the Emergency Department”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05693-9.
- 2022. "The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04163081.
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Conditions
Cancer Related
Treatments