Clinical trial Recruiting at 4 sites Interventional Ages 18 and up

Helping smokers quit during emergency department visits

Official title: The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments

Run by Ottawa Heart Institute Research Corporation · NCT04163081 · Data updated 2026-11-12

This study is testing a new way to help daily smokers quit by giving them support and incentives during their emergency department visits to see if it helps them stay smoke-free for longer.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1208 (estimated)
SponsorOttawa Heart Institute Research Corporation
Academic / other
Locations4 sites (Ottawa, Ontario and 3 other locations)
StatusRecruiting
StartedApril 19, 2022
Main results expectedSeptember 2027
Study endsSeptember 2027
Registry record updatedNovember 4, 2026
Trial IDNCT04163081 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are current daily smokers aged 18 and older who visit emergency departments in Ontario.

Probably not a fit

Patients who are not current smokers or those with severe health conditions that prevent participation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The INITIATE Study is a randomized controlled trial aimed at increasing long-term smoking abstinence among tobacco smokers who visit emergency departments. It involves a Quit Card Intervention (QCI) that provides behavioral incentives and tailored follow-up support to participants. The study targets smokers who are daily users of tobacco and assesses the impact of the intervention on smoking cessation, health outcomes, and healthcare utilization over a 24-month period. With millions of emergency department visits involving smokers each year, this study seeks to address the underutilization of effective smoking cessation interventions in healthcare settings.

Why it matters

Potential benefit: If successful, this study could significantly improve smoking cessation rates among patients who visit emergency departments.

How similar studies have gone: Other studies have shown success with similar interventions in promoting smoking cessation, indicating a promising approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Civic Hospital
    Ottawa, Ontario, Canada
    Recruiting
  • General Hospital
    Ottawa, Ontario, Canada
    Recruiting
  • Riverside Hospital
    Ottawa, Ontario, Canada
    Recruiting
  • University of Ottawa Heart Institute
    Ottawa, Ontario, Canada
    Recruiting

Study contacts

  • Principal investigator: Kerri-Anne Mullen, PhD — Ottawa Heart Institute Research Corporation
  • Study coordinator: Chantelle Masterson, BPhil
  • Email: cmasterson@ottawaheart.ca
  • Phone: 613-696-7000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Ear acupressure plus nicotine replacement to ease withdrawal in psychiatric inpatients

    This study will test whether adding ear acupressure (ear seeds) to standard nicotine replacement therapy helps psychiatric inpatients who must stop smoking reduce withdrawal symptoms, cravings, and anxiety.

    Recruiting TsaoTun Psychiatric Center, Department of Health, Taiwan · Nantou City · NCT07466875

  • Exploring how childhood experiences affect smoking risk in young adults

    This study is trying to see how tough childhood experiences affect the brain's response to nicotine in young adults who don't smoke, to understand why they might be at a higher risk of starting to smoke.

    Recruiting Early Phase 1 Duke University · Durham, North Carolina · NCT05665465

  • Helping smokers practice quitting tobacco

    This study is testing a new way to help smokers practice quitting tobacco by trying short breaks from smoking without pressure, comparing it to regular counseling, to see which method helps them make more quit attempts over six months.

    Recruiting Phase 1/2 Rush University Medical Center · Chicago, Illinois · NCT05513872

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.