Recruiting

Nicotine Dependence

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT04163081

Conditions

Nicotine Dependence, Cigarettes

Nicotine Withdrawal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quit Card Intervention (QCI)

Study Details

Brief 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. 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.

Conditions

Nicotine Dependence, Cigarettes

Nicotine Withdrawal

Study ID

NCT04163081

Start date

Apr 19, 2022

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1208 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Quit Card Intervention (QCI)

Study intervention group.

no intervention: Usual Care (UC)

Study control group.

Interventions

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.

Primary outcome measure

  • Smoking Abstinence [ Time Frame: 26 weeks (6 months) after study enrollment ]

Central Contacts and Locations

Central contacts

Locations

Civic Hospital

Recruiting

Ottawa, Ontario, Canada

Contacts

Dr. Venkatesh Thiruganasambandamoorthy

6137985555,17023vthirug@toh.ca

General Hospital

Recruiting

Ottawa, Ontario, Canada

Contacts

Dr. Venkatesh Thiruganasambandamoorthy

6137985555,17023vthirug@toh.ca

Riverside Hospital

Recruiting

Ottawa, Ontario, Canada

Contacts

Dr. Venkatesh Thiruganasambandamoorthy

6137985555,17023vthirug@toh.ca

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada

Contacts

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • Nicotine Replacement Therapy
  • Emergency Department
  • Nicotine Dependence
  • Tobacco Abstinence
  • Tobacco Treatment
  • Cigarette

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-05-06.