The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments (INITIATE)

April 29, 2026 updated by: Ottawa Heart Institute Research Corporation
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1208

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • Recruiting
        • University of Ottawa Heart Institute
        • Contact:
      • Ottawa, Ontario, Canada
        • Recruiting
        • Civic Hospital
        • Contact:
          • Dr. Venkatesh Thiruganasambandamoorthy
          • Phone Number: 6137985555,17023
          • Email: vthirug@toh.ca
      • Ottawa, Ontario, Canada
        • Recruiting
        • General Hospital
        • Contact:
          • Dr. Venkatesh Thiruganasambandamoorthy
          • Phone Number: 6137985555,17023
          • Email: vthirug@toh.ca
      • Ottawa, Ontario, Canada
        • Recruiting
        • Riverside Hospital
        • Contact:
          • Dr. Venkatesh Thiruganasambandamoorthy
          • Phone Number: 6137985555,17023
          • Email: vthirug@toh.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Quit Card Intervention (QCI)
Study intervention group.
Behavioral: 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.
No Intervention: Usual Care (UC)
Study control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
26 weeks (6 months) after study enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prolonged Abstinence
Time Frame: 4, 26, and 52 weeks after study enrollment
Prolonged (since last time point) smoking abstinence, at 4, 26, and 52 weeks
4, 26, and 52 weeks after study enrollment
Point Prevalence Abstinence
Time Frame: 4, and 52 weeks after study enrollment
Point prevalence smoking abstinence, at 4, and 52 weeks
4, and 52 weeks after study enrollment
Smoking Reduction
Time Frame: 4, 26, and 52 weeks after study enrollment
Smoking reduction (i.e., change in number of daily cigarettes), at 4, 26, and 52 weeks
4, 26, and 52 weeks after study enrollment
Number of Quit Attempts
Time Frame: 4, 26, and 52 weeks after study enrollment
Number of quit attempts since study entry, at 4, 26, and 52 weeks
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 smoking cessation medication and/or e-cigarette, at 4, 26, and 52 weeks
4, 26, and 52 weeks after study enrollment
Use of Behavioural Supports
Time Frame: 4, 26, and 52 weeks after study enrollment
Use of behavioural supports (e.g., counseling, quit lines), at 4, 26, and 52 weeks
4, 26, and 52 weeks after study enrollment
Health-Related Quality of Life
Time Frame: 52 weeks after study enrollment
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.
52 weeks after study enrollment
Health Services Outcomes - ED visits
Time Frame: 4, 26, and 52 weeks after study enrollment
Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) visits to ED at 4, 26, and 52 weeks
4, 26, and 52 weeks after study enrollment
Health Services Outcomes - Hospital Admissions
Time Frame: 4, 26, and 52 weeks after study enrollment
Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) admissions to hospital at 4, 26, and 52 weeks
4, 26, and 52 weeks after study enrollment
Health Services Outcomes - Deaths
Time Frame: 4, 26, and 52 weeks after study enrollment
Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) deaths at 4, 26, and 52 weeks
4, 26, and 52 weeks after study enrollment
Cost-Effectiveness Ratios
Time Frame: 52 weeks after study enrollment
Cost-effectiveness ratios related to health services at 52 weeks
52 weeks after study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Heart Institute Research Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kerri-Anne Mullen, PhD, Ottawa Heart Institute Research Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20190485-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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