NCT03249428Enrolling by invitation
Cytisine vs Nicotine Replacement Therapy
Community-Based Participatory Action Pragmatic Randomized Controlled Trial Using Nicotine Mouth Spray for Tobacco Dependence in the Systemically Disadvantaged Population
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
Tobacco is the most preventable cause of disease and death in Canada. Although the tobacco use rate has substantially gone down in the general population, significant differences exist between sub-populations in Canada, for example Ottawa's highly vulnerable homeless or at-risk for homelessness population has an almost 100% tobacco smoking rate relative to 9-18% in the rest of the Canadian general population. This stark inequity in tobacco use translates into devastating healthcare outcomes such as a disproportionate amount of cancer, stroke, heart disease and death. Canadians who are homeless or at-risk for homelessness die 25 years earlier than housed Canadians, mostly due to tobacco. In order to tackle this tobacco use related inequity - a novel approach is urgently needed. Despite commonly held dogma that People Who Use Drugs (PWUD) don't want to quit smoking, many studies have demonstrated that in fact they are very interested in quitting. Moreover, the investigators pragmatic peer-led community-based action approach used in their PROMPT project has demonstrated that tobacco dependence strategies can be implemented with great success in this population. The majority of PROMPT participants reduced or quit tobacco use, in addition to reducing or quitting all other drug use. Importantly, the investigators have demonstrated that it is possible to gain the trust and engagement of marginalized populations and that researchers can create a community space that is low-threshold, safe and non-judgmental. The investigators aim to compare two tobacco dependence management strategies in the homeless (or at-risk for homelessness) multi-drug use population in Ottawa and Toronto. They will use the same peer-led approach in PROMPT with community peer researchers with lived experience; with the hope that the cost-effective community based framework derived from this trial will serve as a template for interventions and treatments in community settings for chronic diseases such as obesity and diabetes.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 10 Aug 2017
- Start date
- 4 Nov 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Ottawa Hospital Research Institute
- Diseases
- Asthma
- NCT number
- NCT03249428
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 4 Nov 2025 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any person who is in or planning on accessing addictions treatment (in-patient drug rehabilitation) in Ottawa or Toronto and hence will be unavailable for follow up
Other illness
- Terminal illness with a life expectancy of less than 3 months
Other
- Consent declined (refusal from participant or decision maker)
- Currently or recently (in the past 30 days) enrolled in any other smoking cessation program or have used/is using any e-cigs (nicotine or non-nicotine) in the past 60 days
Who the study is looking for
- 18 years or older
- Currently living in Ottawa or Toronto
- Actively used tobacco and/or nicotine products (i.e., cigarettes, vape) in the past 7 days; 2) and want to use NRT or Cytisine
- Identify as being low socioeconomic status, experiencing homelessness or at-risk for homelessness, and/or racialized
- Available for in-person follow-ups for six months
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Bridge Engagement Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.