Nicotine Dependence, CigarettesINITIATENCT04163081
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
A study testing Quit Card Intervention (QCI) in people with Nicotine Dependence, Cigarettes and Nicotine Withdrawal, run by Ottawa Heart Institute Research Corporation at 4 sites in Canada.
Trial summary
The INITIATE Study is a randomized controlled trial that is testing an intervention designed to increase long-term abstinence among tobacco smokers seen in emergency departments (ED) and other high-volume hospital and community ambulatory care settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence, Cigarettes, Nicotine Withdrawal
- What is being tested?
- Quit Card Intervention (QCI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,208 participants
- Where
- 4 sitesCanada
- Study dates
- 19 Apr 2022to Sep 2027
- 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
- Current daily smoker (smokes ≥ 5 cigarettes per day);
- ≥ 18 years of age (the age of majority in Ontario);
- For ED sites only, assigned a CTAS level of 2-5 (emergent to non-urgent);
- Able to read and understand English or French;
- Resides in Ontario and eligible for Ontario Health Insurance Plan (to permit linkage with administrative data housed at the Institute for Clinical Evaluative Sciences [ICES]);
- Available and willing to participate in follow-up assessments over the next 12 months;
- Has access to a telephone or computer;
- Able to provide informed consent
Who cannot join
- Currently participating in this or another smoking cessation study;
- For ED sites only, assigned a CTAS level of 1 (resuscitation - the most seriously ill patients with highest likelihood of hospital admission) or in psychiatric emergency unit;
- Pregnant, planning to become pregnant over the next year, or breastfeeding;
- Has morbid illness which will prevent completion of 26-week follow-up (e.g., receiving palliative care);
- In the opinion of the attending physician, manifests acute physical and/or psychiatric illness or has cognitive impairment that would preclude participation in/benefit from the intervention.
- Scheduled for a known elected surgery, procedure, or future hospitalization during the study period.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
Civic Hospital
Ottawa, Ontario
Dr. Venkatesh Thiruganasambandamoorthy, 6137985555,17023, vthirug@toh.ca
- Recruiting
General Hospital
Ottawa, Ontario
Dr. Venkatesh Thiruganasambandamoorthy, 6137985555,17023, vthirug@toh.ca
- Recruiting
Riverside Hospital
Ottawa, Ontario
Dr. Venkatesh Thiruganasambandamoorthy, 6137985555,17023, vthirug@toh.ca
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
Dr. Kerri-Anne Mullen, 613-696-7000 ext.19095, KMullen@ottawaheart.ca
About this study
The INITIATE Study is a randomized controlled trial that is testing an intervention designed to increase long-term abstinence among tobacco smokers seen in emergency departments (ED) and other high-volume hospital and community ambulatory care settings. The intervention includes a behavioural incentive and tailored follow-up support on long-term smoking abstinence, health, healthcare utilization, and cost. Tobacco-related illnesses cost the healthcare system millions each year. Quitting smoking improves smoking-related outcomes, like the onset or management of heart disease, stroke, lung diseases, and several cancers. There are approximately 16 million visits to Canadian EDs each year; an estimated 3-4 million of these involve smokers. Effective quit smoking interventions exist, but are underutilized. Few hospital EDs, community healthcare centers, and other inpatient and outpatient clinics in Canada offer tobacco-use interventions. In order for clinicians to offer quit smoking support, interventions need to be simple given the realities of these high-volume environments. Considering that stopping smoking improves health outcomes, that tobacco-use is an important cause of preventable ED use, and the volume of smokers, Canadian EDs and other high-volume hospital and community ambulatory care settings are a missed opportunity in the initiation of quit smoking support. Our intervention has been designed to optimize uptake and smoking abstinence by including the most effective evidence-based behavioural and drug-related approaches, removing specific barriers and challenges that smokers face when trying to quit (e.g., affordability, low confidence and motivation), while packaging the intervention in a quick-to-initiate manner, making it ideal for fast-paced, complex environments.
- Being tested
- Quit Card Intervention (QCI)
- Keywords
- Nicotine Replacement Therapy, Emergency Department, Nicotine Dependence, Tobacco Abstinence, Tobacco Treatment, Cigarette
- Medical subject headings
- Tobacco Use Disorder, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quit Card Intervention (QCI)Behavioural
The intervention is comprised of a behavioural incentive in the form of a gift card as well as tailored smoking cessation counseling. Eligible consenting smokers randomized to the QCI group will receive: a "Quit Card" (a gift card worth $300 that can be used to buy nicotine replacement therapies at any pharmacy); self-help information; and, enrollment in six months of telephone follow-up support tailored by treatment goal with a Nicotine Addiction Treatment Specialist.
| Study group | Role | What they receive |
|---|---|---|
| Quit Card Intervention (QCI) | Experimental | Study intervention group. Receives: Behavioral: Quit Card Intervention (QCI) |
| Usual Care (UC) | No intervention | Study control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
Smoking abstinence at 26 weeks, biochemically verified using an expired air carbon monoxide (CO) test
Measured: 26 weeks (6 months) after study enrollment
Secondary outcomes (11)
Prolonged Abstinence
Prolonged (since last time point) smoking abstinence, at 4, 26, and 52 weeks
Measured: 4, 26, and 52 weeks after study enrollment
Point Prevalence Abstinence
Point prevalence smoking abstinence, at 4, and 52 weeks
Measured: 4, and 52 weeks after study enrollment
Smoking Reduction
Smoking reduction (i.e., change in number of daily cigarettes), at 4, 26, and 52 weeks
Measured: 4, 26, and 52 weeks after study enrollment
Number of Quit Attempts
Number of quit attempts since study entry, at 4, 26, and 52 weeks
Measured: 4, 26, and 52 weeks after study enrollment
Cessation Medication and/or E-cigarette Use
Use of smoking cessation medication and/or e-cigarette, at 4, 26, and 52 weeks
Measured: 4, 26, and 52 weeks after study enrollment
Use of Behavioural Supports
Use of behavioural supports (e.g., counseling, quit lines), at 4, 26, and 52 weeks
Measured: 4, 26, and 52 weeks after study enrollment
Health-Related Quality of Life
Health-related quality of life (HR-QoL), at 52 weeks. This will be measured using the Hospital Anxiety and Depression Scale (HADS), designed to identify and measure the levels of anxiety and depression among individuals in non-psychiatric hospital settings, and the Health Questionnaire Assessment (EQ-5D-5L), using five graded severity levels to summarize perceived health across five foundational dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: 52 weeks after study enrollment
Health Services Outcomes - ED visits
Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) visits to ED at 4, 26, and 52 weeks
Measured: 4, 26, and 52 weeks after study enrollment
Health Services Outcomes - Hospital Admissions
Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) admissions to hospital at 4, 26, and 52 weeks
Measured: 4, 26, and 52 weeks after study enrollment
Health Services Outcomes - Deaths
Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) deaths at 4, 26, and 52 weeks
Measured: 4, 26, and 52 weeks after study enrollment
Cost-Effectiveness Ratios
Cost-effectiveness ratios related to health services at 52 weeks
Measured: 52 weeks after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start19 Apr 2022
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine Dependence, CigarettesStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Kerri-Anne Mullen, PhD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163081
- Sponsor's protocol ID
- 20190485-01H
- Acronym
- INITIATE
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2019
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mullen KA, Garg A, Gagnon F, Wells G, Kapur A, Hawken S, Pipe AL, Walker K, Thiruganasambandamoorthy V, Klepaczek M, Reid RD. 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. 2021 Oct 23;22(1):733. doi: 10.1186/s13063-021-05693-9.
PubMed 34688291
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
- ClinicalTrials.gov ID
- NCT04163081
- Acronym / sponsor ID
- INITIATE / 20190485-01H
- Keywords
- Nicotine Replacement Therapy, Emergency Department, Nicotine Dependence, Tobacco Abstinence, Tobacco Treatment, Cigarette
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,208 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 14 Nov 2019 (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.
The INITIATE Study is a randomized controlled trial that is testing an intervention designed to increase long-term abstinence among tobacco smokers seen in emergency departments (ED) and other high-volume hospital and community ambulatory care settings. The intervention includes a behavioural incentive and tailored follow-up support on long-term smoking abstinence, health, healthcare utilization, and cost. Tobacco-related illnesses cost the healthcare system millions each year. Quitting smoking improves smoking-related outcomes, like the onset or management of heart disease, stroke, lung diseases, and several cancers. There are approximately 16 million visits to Canadian EDs each year; an estimated 3-4 million of these involve smokers. Effective quit smoking interventions exist, but are underutilized. Few hospital EDs, community healthcare centers, and other inpatient and outpatient clinics in Canada offer tobacco-use interventions. In order for clinicians to offer quit smoking support, interventions need to be simple given the realities of these high-volume environments. Considering that stopping smoking improves health outcomes, that tobacco-use is an important cause of preventable ED use, and the volume of smokers, Canadian EDs and other high-volume hospital and community ambulatory care settings are a missed opportunity in the initiation of quit smoking support. Our intervention has been designed to optimize uptake and smoking abstinence by including the most effective evidence-based behavioural and drug-related approaches, removing specific barriers and challenges that smokers face when trying to quit (e.g., affordability, low confidence and motivation), while packaging the intervention in a quick-to-initiate manner, making it ideal for fast-paced, complex environments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quit Card Intervention (QCI) | Experimental | Behavioral: Quit Card Intervention (QCI)Study intervention group. |
| Usual Care (UC) | No intervention | –Study control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Current daily smoker (smokes ≥ 5 cigarettes per day);
- ≥ 18 years of age (the age of majority in Ontario);
- For ED sites only, assigned a CTAS level of 2-5 (emergent to non-urgent);
- Able to read and understand English or French;
- Resides in Ontario and eligible for Ontario Health Insurance Plan (to permit linkage with administrative data housed at the Institute for Clinical Evaluative Sciences [ICES]);
Key exclusion criteria (6 listed)
- Currently participating in this or another smoking cessation study;
- For ED sites only, assigned a CTAS level of 1 (resuscitation - the most seriously ill patients with highest likelihood of hospital admission) or in psychiatric emergency unit;
- Pregnant, planning to become pregnant over the next year, or breastfeeding;
- Has morbid illness which will prevent completion of 26-week follow-up (e.g., receiving palliative care);
- In the opinion of the attending physician, manifests acute physical and/or psychiatric illness or has cognitive impairment that would preclude participation in/benefit from the intervention.
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 |
|---|---|---|
| Quit Card Intervention (QCI)The intervention is comprised of a behavioural incentive in the form of a gift card as well as tailored smoking cessation counseling. Eligible consenting smokers randomized to the QCI group will receive: a "Quit Card" (a gift card worth $300 that can be used to buy nicotine replacement therapies at any pharmacy); self-help information; and, enrollment in six months of telephone follow-up support tailored by treatment goal with a Nicotine Addiction Treatment Specialist. | Behavioural | Quit Card Intervention (QCI) |
Primary outcome
Smoking Abstinence
Time frame: 26 weeks (6 months) after study enrollment
Smoking abstinence at 26 weeks, biochemically verified using an expired air carbon monoxide (CO) test
11 secondary outcomes
Prolonged Abstinence
Time frame: 4, 26, and 52 weeks after study enrollment
Point Prevalence Abstinence
Time frame: 4, and 52 weeks after study enrollment
Smoking Reduction
Time frame: 4, 26, and 52 weeks after study enrollment
Number of Quit Attempts
Time frame: 4, 26, and 52 weeks after study enrollment
Cessation Medication and/or E-cigarette Use
Time frame: 4, 26, and 52 weeks after study enrollment
Use of Behavioural Supports
Time frame: 4, 26, and 52 weeks after study enrollment
Health-Related Quality of Life
Time frame: 52 weeks after study enrollment
Health Services Outcomes - ED visits
Time frame: 4, 26, and 52 weeks after study enrollment
Health Services Outcomes - Hospital Admissions
Time frame: 4, 26, and 52 weeks after study enrollment
Health Services Outcomes - Deaths
Time frame: 4, 26, and 52 weeks after study enrollment
Cost-Effectiveness Ratios
Time frame: 52 weeks after study enrollment
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 4 Nov 2026.
- Derived from this study: PubMed 34688291Mullen KA, Garg A, Gagnon F, Wells G, Kapur A, Hawken S, Pipe AL, Walker K, Thiruganasambandamoorthy V, Klepaczek M, Reid RD. 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. 2021 Oct 23;22(1):733. doi: 10.1186/s13063-021-05693-9.
- 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.
Kerri-Anne Mullen, PhD principal investigator
Ottawa Heart Institute Research Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quit Card Intervention (QCI) in people with Nicotine Dependence, Cigarettes and Nicotine Withdrawal, run by Ottawa Heart Institute Research Corporation at 4 sites in Canada.
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 8 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Chantelle Masterson, BPhil (613-696-7000 ext. 19157, cmasterson@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Abstinence (time frame: 26 weeks (6 months) after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04163081, which also lists 1 linked publication.
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 4 Nov 2026.