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New study aims to help vulnerable canadians quit smoking with nicotine spray and cytisine

NCT ID NCT03249428

Disease control Sponsor: Ottawa Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two approaches to help people who are homeless or at risk of homelessness quit smoking: cytisine (a plant-based pill) versus nicotine replacement therapy (like mouth spray, patches, or gum). Both groups also get counseling. The goal is to see which strategy works better and improves quality of life. The trial involves 200 participants in Ottawa and Toronto.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cytisine and nicotine replacement therapy (mouth spray, patches, gum, lozenges, inhalers)
What this could lead to
If successful, this could provide an effective, low-cost way to help disadvantaged populations quit smoking, reducing tobacco-related deaths and improving quality of life.
What could go wrong
This is a small, early-stage trial (200 participants) with no blinding, so results may not be generalizable. Quit rates may be low, and participants may relapse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Consent declined (refusal from participant or decision maker) * 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 * 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 * Terminal illness with a life expectancy of less than 3 months

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Conditions

The condition(s) this trial relates to.

nicotine dependence psychiatric disorder substance abuse substance-related disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COPD asthma Mental illness Substance use Tobacco dependence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Bridge Engagement Centre

    Ottawa, Ontario, K1K 4B7, Canada

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