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

Recruiting now · Not applicable

Conditions studied: Nicotine Dependence, Cigarettes, Nicotine Withdrawal

In brief

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.

Key facts

Study ID: NCT04163081
Run by: Ottawa Heart Institute Research Corporation
People needed: 1208
Starts: 2022-04-19
Expected to finish: 2027-03-01
Last updated by the study team: 2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Civic Hospital — Ottawa, Ontario, Canada (enrolling)
General Hospital — Ottawa, Ontario, Canada (enrolling)
Riverside Hospital — Ottawa, Ontario, Canada (enrolling)
University of Ottawa Heart Institute — Ottawa, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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