Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04163081 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: INITIATE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 6, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion date: Aug 2025 to Sep 2026v16
  2. Minor Study sites: 3 to 4
    • Secondary endpoints: details revised at 11 of 11 entries
    • Eligibility criteria shortened, about 1 word
    v15
  3. Minor Study sites: 2 to 3v14
  4. Minor Study completion date: Nov 2026 to Mar 2027
    • Eligibility criteria expanded, about 22 words
    v13
  5. Notable Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v11
  2. Notable Primary completion date: Jul 2023 to Aug 2025
    • Study completion date: Nov 2025 to Nov 2026
    v10
  3. Minor Re-verified, no change to tracked fieldsv9
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jul 2022 to Jul 2023
    • Start date changed from estimate of Jun 1, 2021 to Apr 19, 2022
    • Site details revised at 2 of 2 sites
    v8
  5. Notable Start date: Apr 10, 2021 to Jun 1, 2021v7
  6. Notable Primary completion date: Jul 2021 to Jul 2022
    • Start date: Nov 30, 2020 to Apr 10, 2021
    • Study completion date: Nov 2022 to Nov 2025
    v6
  7. Notable Start date: Aug 2020 to Nov 30, 2020v5
  8. Notable Start date: Apr 2020 to Aug 2020v4
  9. Notable Start date: Feb 2020 to Apr 2020v3
  10. Notable Start date: Nov 2019 to Feb 2020v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04163081
Lead Sponsor Ottawa Heart Institute Research Corporation
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions
(from sponsor)
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Related terms Emergencies, Tobacco Use Disorder
Enrollment 1,208 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov