Tobacco DependenceNCT03249428
Cytisine vs Nicotine Replacement Therapy
A study testing Cytisine and Nicotine replacement therapy (NRT) in people with Tobacco Dependence and COPD Asthma, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence, COPD Asthma, Mental Illness
- What is being tested?
- Cytisine and Nicotine replacement therapy (NRT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 4 Nov 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Community-Based Participatory Action Pragmatic Randomized Controlled Trial Using Nicotine Mouth Spray for Tobacco Dependence in the Systemically Disadvantaged Population
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.
Read the detailed description
Aim: A 3-yr multi-centre, pragmatic Randomized Controlled Trial (RCT) to compare effectiveness of Cytisine (with counseling) with peer-led PROMPT strategy (nicotine replacement therapy (NRT) and counseling) for tobacco dependence in the inner-city population.
Background: Homelessness/at-risk for homelessness populations in Canada carry disproportionate burden of many diseases, mostly due to tobacco. With smoking rates at ~100% in some subpopulations as compared to 9-18% in the general population, tobacco inequity is translated into unequal morbidity and mortality (COPD, cancers, heart diseases). Tobacco use costs the Ontario economy ~$1.6 billion/year in healthcare costs. Smoking attributable hospitalization costs ~$38.2 million/year in Ottawa alone from 2008-10. The inner-city population in Canada dies ~25 years earlier than housed Canadians, largely due to tobacco. With negligible quit rates using conventional strategies, novel approaches to address tobacco inequity are urgently needed.
Cytisine is a naturally occurring alkaloid that has long been used as a tobacco dependence treatment and management aid in Eastern Europe. Health Canada has approved Cytisine as an over-the-counter health product, and the Canadian Agency for Drugs and Technologies in Health (CADTH) has determined Cytisine to be a cost-effective tobacco dependence treatment and management aid. Given its cost-effectiveness and affordability compared to nicotine replacement therapy, Cytisine may be more accessible and effective for marginalized populations. Cytisine will be made available to study participants as a Health Canada licensed natural health product.
Study Population: 200 Toronto and Ottawa inner city homeless/at-risk for homelessness participants using poly-substances.
Primary Patient-Oriented Outcome: To assess the impact of two pragmatic tobacco dependence strategies on changes in QOL and GAINSS score measured with the EQ-5D-5L; Secondary: i) To assess effectiveness of these two strategies with biochemically validated smoking abstinence at 13 and 26 weeks; ii) To assess effectiveness of these two strategies on conventional cigarette and/or e-cigarette consumption reduction and cessation at 13 and 26 weeks; iii) To assess self-reported reduction and cessation of other substance use at 13 and 26 weeks; and; iv) To describe the safety/tolerability of Cytisine or NRT SAEs, AEs, and drop-outs due to side effects, along with therapy adherence over 26 weeks; and, v) To compare lung function using oscillometry and spirometry, as well as self-efficacy at baseline, 13 weeks, and 26 weeks; Tertiary: i) To assess the cost-effectiveness of the pragmatic tobacco dependence strategies.
Study Design: A multi-centre pragmatic RCT trial comparing Cytisine (with nicotine) with counseling or NRT with counseling for a 13-week treatment period and 26-week follow up. Similar to the real world, all participants will be given an opportunity to choose either strategy at 26 wks. The primary analysis will be change in QOL and GAINSS score measured with the EQ-5D-5L at 13 weeks between participants.
Setting: 1) The Bridge Engagement Centre, Ottawa, adjacent to the largest homeless shelter downtown; and 2) The Parkdale Activity-Recreation Centre.
Expertise: The PI is well versed in community-based research and very experienced in tobacco dependence and the target population. She led the PROMPT project, a community-based smoking cessation project engaging the same target population.
Outcomes: Pragmatic community-based participatory and peer-led research holds a tremendous potential in investigating solutions 'for the people, by and with the people'. Outcomes of this trial will aid policy makers in implementing effective programs to treat tobacco dependence in marginalized population. The cost-effective community-based framework of this trial can be used as a template for intervention in other chronic diseases (e.g. obesity or diabetes).
Timeline: The trial will require 3 yrs to complete.
- Conditions
- Tobacco Dependence, COPD Asthma, Mental Illness, Substance Use
- Being tested
- Cytisine, Nicotine replacement therapy (NRT)
- Medical subject headings
- Tobacco Use Disorder, Mental Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytisineDrug
Cytisine: 2x 1.5mg capsules 3 times a day (3mg 3 times a day).
Nicotine replacement therapy (NRT)Drug
Nicotine Replacement Therapy (NRT): nicotine mouth sprays, nicotine patches, nicotine gum, nicotine lozenges, and nicotine oral inhalers
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Replacement Therapy (NRT) | Active comparator | Nicotine Replacement Therapy (NRT): nicotine mouth spray, nicotine patches, nicotine gum, nicotine lozenges, and nicotine oral inhalers Receives: Drug: Nicotine replacement therapy (NRT) |
| Cytisine | Active comparator | Cytisine: 2x 1.5mg capsules 3 times a day (3mg 3 times a day). Receives: Drug: Cytisine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Quality of Life
To assess impact of two tobacco dependence strategies on quality of life (QOL) measured by questionnaire (EQ-5D-5L scores)
Measured: 13 weeks
Secondary outcomes (5)
Smoking Prevalence
To assess effectiveness of two strategies (Cytisine with smoking cessation counseling vs NRT with smoking cessation counseling) with biochemically validated smoking abstinence at 13 and 26 weeks
Measured: 26 weeks
Tobacco and e-cigarette (with nicotine) use
To assess effectiveness of these two strategies on conventional cigarette and/or e-cigarette consumption reduction and cessation at 13 and 26 weeks
Measured: 26 weeks
Substance use
To assess self-reported reduction and cessation of other substance use at 13 and 26 weeks
Measured: 26 weeks
Safety and tolerability of Cytisine or NRT
To describe the safety/tolerability of Cytisine or NRT SAEs, AEs, and drop-outs due to side effects, along with therapy adherence over 26 weeks
Measured: 26 weeks
Lung function
To compare lung function using oscillometry and spirometry, as well as self-efficacy at baseline, 13 weeks, and 26 weeks
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start4 Nov 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3-yr multi-centre pragmatic Randomized Controlled Trial (RCT) to compare effectiveness of nicotine e-cigarettes (e-cigs) (with counseling) with peer-led PROMPT strategy (nicotine replacement therapy (NRT) and counseling) for tobacco dependence in the inner city population.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Smita Pakhale, MD, MSc, Principal investigator, The Ottawa Hospital, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249428
- Sponsor's protocol ID
- 20240335-01H
- Status last verified
- Mar 2026
- First submitted
- 10 Aug 2017
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Participatory Action Pragmatic Randomized Controlled Trial Using Nicotine Mouth Spray for Tobacco Dependence in the Systemically Disadvantaged Population
- ClinicalTrials.gov ID
- NCT03249428
- Acronym / sponsor ID
- 20240335-01H
- Conditions
- Tobacco Dependence, COPD Asthma, Mental Illness, Substance Use
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim: A 3-yr multi-centre, pragmatic Randomized Controlled Trial (RCT) to compare effectiveness of Cytisine (with counseling) with peer-led PROMPT strategy (nicotine replacement therapy (NRT) and counseling) for tobacco dependence in the inner-city population.
Background: Homelessness/at-risk for homelessness populations in Canada carry disproportionate burden of many diseases, mostly due to tobacco. With smoking rates at ~100% in some subpopulations as compared to 9-18% in the general population, tobacco inequity is translated into unequal morbidity and mortality (COPD, cancers, heart diseases). Tobacco use costs the Ontario economy ~$1.6 billion/year in healthcare costs. Smoking attributable hospitalization costs ~$38.2 million/year in Ottawa alone from 2008-10. The inner-city population in Canada dies ~25 years earlier than housed Canadians, largely due to tobacco. With negligible quit rates using conventional strategies, novel approaches to address tobacco inequity are urgently needed.
Cytisine is a naturally occurring alkaloid that has long been used as a tobacco dependence treatment and management aid in Eastern Europe. Health Canada has approved Cytisine as an over-the-counter health product, and the Canadian Agency for Drugs and Technologies in Health (CADTH) has determined Cytisine to be a cost-effective tobacco dependence treatment and management aid. Given its cost-effectiveness and affordability compared to nicotine replacement therapy, Cytisine may be more accessible and effective for marginalized populations. Cytisine will be made available to study participants as a Health Canada licensed natural health product.
Study Population: 200 Toronto and Ottawa inner city homeless/at-risk for homelessness participants using poly-substances.
Primary Patient-Oriented Outcome: To assess the impact of two pragmatic tobacco dependence strategies on changes in QOL and GAINSS score measured with the EQ-5D-5L; Secondary: i) To assess effectiveness of these two strategies with biochemically validated smoking abstinence at 13 and 26 weeks; ii) To assess effectiveness of these two strategies on conventional cigarette and/or e-cigarette consumption reduction and cessation at 13 and 26 weeks; iii) To assess self-reported reduction and cessation of other substance use at 13 and 26 weeks; and; iv) To describe the safety/tolerability of Cytisine or NRT SAEs, AEs, and drop-outs due to side effects, along with therapy adherence over 26 weeks; and, v) To compare lung function using oscillometry and spirometry, as well as self-efficacy at baseline, 13 weeks, and 26 weeks; Tertiary: i) To assess the cost-effectiveness of the pragmatic tobacco dependence strategies.
Study Design: A multi-centre pragmatic RCT trial comparing Cytisine (with nicotine) with counseling or NRT with counseling for a 13-week treatment period and 26-week follow up. Similar to the real world, all participants will be given an opportunity to choose either strategy at 26 wks. The primary analysis will be change in QOL and GAINSS score measured with the EQ-5D-5L at 13 weeks between participants.
Setting: 1) The Bridge Engagement Centre, Ottawa, adjacent to the largest homeless shelter downtown; and 2) The Parkdale Activity-Recreation Centre.
Expertise: The PI is well versed in community-based research and very experienced in tobacco dependence and the target population. She led the PROMPT project, a community-based smoking cessation project engaging the same target population.
Outcomes: Pragmatic community-based participatory and peer-led research holds a tremendous potential in investigating solutions 'for the people, by and with the people'. Outcomes of this trial will aid policy makers in implementing effective programs to treat tobacco dependence in marginalized population. The cost-effective community-based framework of this trial can be used as a template for intervention in other chronic diseases (e.g. obesity or diabetes).
Timeline: The trial will require 3 yrs to complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 3-yr multi-centre pragmatic Randomized Controlled Trial (RCT) to compare effectiveness of nicotine e-cigarettes (e-cigs) (with counseling) with peer-led PROMPT strategy (nicotine replacement therapy (NRT) and counseling) for tobacco dependence in the inner city population.
| Arm | Type | Receives |
|---|---|---|
| Nicotine Replacement Therapy (NRT) | Active comparator | Drug: Nicotine replacement therapy (NRT)Nicotine Replacement Therapy (NRT): nicotine mouth spray, nicotine patches, nicotine gum, nicotine lozenges, and nicotine oral inhalers |
| Cytisine | Active comparator | Drug: CytisineCytisine: 2x 1.5mg capsules 3 times a day (3mg 3 times a day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytisineCytisine: 2x 1.5mg capsules 3 times a day (3mg 3 times a day). | Drug | Cytisine |
| Nicotine replacement therapy (NRT)Nicotine Replacement Therapy (NRT): nicotine mouth sprays, nicotine patches, nicotine gum, nicotine lozenges, and nicotine oral inhalers | Drug | Nicotine Replacement Therapy (NRT) |
Primary outcome
Overall Quality of Life
Time frame: 13 weeks
To assess impact of two tobacco dependence strategies on quality of life (QOL) measured by questionnaire (EQ-5D-5L scores)
5 secondary outcomes
Smoking Prevalence
Time frame: 26 weeks
Tobacco and e-cigarette (with nicotine) use
Time frame: 26 weeks
Substance use
Time frame: 26 weeks
Safety and tolerability of Cytisine or NRT
Time frame: 26 weeks
Lung function
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Smita Pakhale, MD, MSc principal investigator
The Ottawa Hospital, Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytisine and Nicotine replacement therapy (NRT) in people with Tobacco Dependence and COPD Asthma, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Quality of Life (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.