Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04163081

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

Led by Ottawa Heart Institute Research Corporation · Updated on 2026-05-06

1208

Participants Needed

4

Research Sites

25 weeks

Total Duration

On this page

Sponsors

O

Ottawa Heart Institute Research Corporation

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an intervention aimed at increasing long-term smoking abstinence among tobacco smokers who visit emergency departments and other busy hospital and community healthcare settings. This randomized controlled trial focuses on improving quit rates by combining behavioral incentives with tailored follow-up support. Smoking causes many preventable health problems, including heart disease, stroke, lung diseases, and cancers, and quitting can reduce these risks. The study addresses the gap in quit smoking support offered in high-volume care environments in Canada. The intervention group receives a "Quit Card," which is a $300 gift card to purchase nicotine replacement therapies at pharmacies, along with self-help materials and six months of personalized telephone counseling from a Nicotine Addiction Treatment Specialist. Participants are randomly assigned to either this Quit Card Intervention (QCI) group or a usual care group that receives no intervention. The study design allows for direct comparison of the impact of this behavioral and drug-related support against standard care. Participants will be followed for up to 12 months, with assessments at 4, 26 (6 months), and 52 weeks after enrollment. Researchers will measure smoking abstinence, quit attempts, smoking reduction, use of cessation medications or e-cigarettes, behavioral support use, quality of life, healthcare visits, hospital admissions, deaths, and cost-effectiveness. Follow-up includes telephone assessments and linkage to health administrative data. The total participation duration covers one year with multiple evaluations to understand long-term outcomes and healthcare impacts.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Current daily smoker who smokes 5 or more cigarettes per day
  • 18 years of age or older
  • For emergency department sites, assigned a CTAS level between 2 and 5 (emergent to non-urgent)
  • Able to read and understand English or French
  • Resident of Ontario with eligibility for Ontario Health Insurance Plan
  • Available and willing to participate in follow-up assessments for 12 months
  • Has access to a telephone or computer
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Currently participating in this or another smoking cessation study
  • For emergency department sites, assigned a CTAS level of 1 (resuscitation) or admitted to a psychiatric emergency unit
  • Pregnant, planning to become pregnant within the next year, or breastfeeding
  • Has a serious illness that prevents completion of 26-week follow-up (e.g., receiving palliative care)
  • Has acute physical or psychiatric illness or cognitive impairment that would prevent participation or benefit, as judged by the attending physician
  • Scheduled for an elective surgery, procedure, or planned hospitalization during the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at emergency department

Treatment

Duration - 6 months

Participants receive a Quit Card gift card, self-help information, and tailored smoking cessation counseling with telephone follow-up support for six months.

Telephone follow-up visits over 6 months

Follow-up

Duration - 6 months

Participants are followed for an additional 6 months to assess smoking abstinence and other outcomes.

Follow-up assessments at 4, 26, and 52 weeks after enrollment

Trial Site Locations

Total: 4 locations

1

Civic Hospital

Ottawa, Ontario, Canada

Actively Recruiting

2

General Hospital

Ottawa, Ontario, Canada

Actively Recruiting

3

Riverside Hospital

Ottawa, Ontario, Canada

Actively Recruiting

4

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Actively Recruiting

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Research Team

C

Chantelle Masterson, BPhil

E

Evyanne Wooding, R.Kin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Kerri A Mullen, Aditi Garg, Frederick Gagnon...

https://pubmed.ncbi.nlm.nih.gov/34688291