Tobacco UseTCAY-OttawaNCT04812613
Tobacco-Concurrent Addictions in At-Risk Youth in Ottawa
An observational study of Tobacco Use and Substance Use, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
According to the 2015 Ontario Student Drug Use and Health Survey (OSDUHS), there has been a significant increase in the number of secondary school youth who use poly-substances. Not all youth have the same risk for problematic substance use. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tobacco Use, Substance Use, Cannabis Use
- How many people
- 520 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to 31 Dec 2027
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 20 youth and 500 adult participants
Who may be able to join
- Are currently living in Ottawa for at least 3 months prior to enrolment.
- Are homeless or insecurely housed (from OCH and the Bridge).
- 16 years or older.
- currently use or have a past history of cannabis use
- Self-report a mental illness.
Who cannot join
- Not meeting inclusion criteria
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: Tobacco Concurrent Addictions in At-Risk Youth in Ottawa: A Mixed Methods Community-Based Participatory Action Research Project (TCAY- Ottawa)
According to the 2015 Ontario Student Drug Use and Health Survey (OSDUHS), there has been a significant increase in the number of secondary school youth who use poly-substances. Not all youth have the same risk for problematic substance use. Health literature documents a high level of comorbidity between mental health and substance use, which is exacerbated in homeless youth populations. Therefore, the proposed study will focus on understanding poly-substance use among at-risk homeless school youth. As seen in substance use research and the PROMPT (2016) study (Participatory Research in Ottawa: Management and Point-of-Care for Tobacco Dependence, PI: Dr. Smita Pakhale), reduction and quitting of one substance (tobacco smoking) can lead to the reduction and quitting of other poly-substance use. A Community-Based Participatory Action Research (CBPAR) approach can help at-risk youth feel safe and comfortable enough to provide personal information about their poly-substance use and engagement with treatment or harm reduction programs. This project will be a first step in increasing health equity among at-risk homeless youth in Downtown Ottawa. The investigators aim to follow a group of at-risk youth to while providing an appropriately modified PROMPT intervention, including peers support and a licensed mental health and substance use nurse.
Read the detailed description
Part 1: Youth and Polysubstance Use This study aims to expand the reach of the existing PROMPT intervention operationalized at the Bridge for vulnerable polysubstance using youth who smoke tobacco. The peer-led PROMPT intervention aims to reduce rates of tobacco smoking and poly-substances use among populations who are homeless or at-risk for homelessness.
Research Objectives:
Understand the positive and negative experiences of cannabis use, the effect of cannabis use on mental health, and recognize the patterns of cannabis use between different generations among marginalized populations with a disproportionate burden of mental illness. Additionally, use meaningful qualitative methods to encourage storytelling and authentic sharing of individual experiences of cannabis use and mental health.
Sub-objectives: 1) Identify trends in tobacco and poly-substance use among at-risk youth in Ottawa. Surveys and interview guides have been created with the intention of understanding the root cause of tobacco and poly-substance use among at-risk youth who attend alternative schooling, their perception of tobacco/drug use, types of tobacco and drug use that are most prevalent among these youth, and where youth access tobacco and other substances.
- Appropriately modify and implement the peer-led PROMPT intervention for 20 youth recruited into the program. The peer-led intervention includes free access to nurse counselling and support on homelessness, addictions, and mental health. You will also access a safe and non-judgemental space for one-to-one peer support. Modifications to this intervention will be dependent on the findings from data collected in the first phase of the study (sub-objective 1).
- Upon completion of the research project, a manuscript will be submitted for publication in a peer-reviewed, open access journal, and various knowledge translation initiatives (e.g., infographics, seminars, etc.) will be undertaken to ensure that study findings are meaningfully available to organizations that serve at-risk youth who smoke tobacco and/or use poly-substances.
- Compare healthcare utilization (ER visits and hospitalizations) over one year after the study by linking the trial data to health administrative data available at the Institute for Clinical and Evaluative Sciences (ICES).
Part 2: Tobacco, Cannabis, and Mental Health Marginalized groups, such as polysubstance using street-involved, homeless, and/or racialized individuals, have been overlooked by studies that investigated the causal relationship between cannabis and mental health. As a result, a paucity of data exists on the motives and reasons that influence cannabis use in these populations, and their potential impact on mental health. This knowledge gap is concerning as marginalized groups experience disproportionate rates of mental illness, and due to social and structural inequities are more likely to abuse drugs, including cannabis, relative to the general population. Therefore, the unique experiences of this population should be investigated to further our understanding on the relationship between polysubstance use, cannabis, and mental health.
In marginalized communities, patterns of cannabis use, including type, duration, and frequency of use, may mediate the mental health effects of cannabis. While recreational cannabis is legal in Canada, marginalized populations may have limited access to Ontario's legal cannabis retailers. As a result, individuals may seek illegal or 'street' cannabis, which may be combined with other illicit drugs and/or tobacco that could influence mental health. Therefore, patterns of cannabis consumption, and the source of cannabis, should be evaluated in relation to mental health.
In light of the above, we propose the use of mixed methods to investigate the lived experience of people with mental illness, risk for cardiovascular disease, and current or past history of cannabis use. Cannabis use is a modifiable risk factor for poor mental health and cardiovascular disease. Using a qualitative focus group approach, we will prospectively explore patterns of cannabis use, tobacco use/other substance use, and their impact on mental health (e.g., depression, anxiety) and physical health (risk factors for cardiovascular disease). Using a quantitative survey, we will quantify the substance use (cannabis and other substance use), physical and mental health, and the prevalence of cardiovascular disease risk factors. The study will be carried out in conjunction with The Bridge Engagement Centre (The Bridge), which has over six years of Community Based Participatory Research (CBPR) experience with marginalized communities, including: people experiencing homeless or at-risk of homelessness, People Who Use Drugs (PWUD), racialized populations, and Indigenous peoples.
Research Objectives:
Objective 1: To understand perceptions, beliefs, cultural practices, and factors that influence cannabis use among marginalized populations with a disproportionate burden of mental illness.
Objective 2: To explore positive and negative experiences of cannabis use in marginalized populations with a disproportionate burden of mental illness.
Objective 3: To understand patterns of cannabis use from adolescence to adulthood and its perceived relationship to mental health in marginalized populations with mental illness.
Objective 4: To understand patterns of cannabis use and its effect on mental health in marginalized populations.
Objective 5: To understand different patterns of cannabis use and its effect on mental health in marginalized populations, specifically looking at youth and adult experiences simultaneously.
Objective 6: To use qualitative methods to encourage storytelling and authentic sharing of individual experiences of mental health and cannabis use among youth populations.
Objective 7: To quantify the prevalence of cardiovascular risk factors among marginalized populations with a cannabis use disorder and poor mental health.
Objective 8: To co-produce knowledge on cardiovascular disease prevention strategies for marginalized populations that use cannabis and report poor mental health.
Study Design:
Phase 1: will involve gathering information on the root causes or facilitators of poly-substance use among at-risk youth, the types of drug use that is most prevalent among at-risk youth, and the early and ongoing points of access to licit and illicit substances.
Phase 2: will involve a single arm prospective cohort study looking to tackle poly-substance use in marginalized youth by providing an individualized, youth-tailored (i.e. based on qualitative results obtained in phase I), social-based intervention with optional access to a licensed mental health and substance use nurse counselling.
A team of community-based (peer) researchers will enroll 20 youth and 500 adult and youth (16 years and older) participants from Operation Come Home and the Bridge, respectively using iPads for the proposed TCAY-Ottawa study. Participants will be eligible if they: 1) are currently living in Ottawa for at least 3 months prior to enrolment, 2) are homeless or insecurely housed (from Operation Come Home and the Bridge), 3) 16 years or older, 4) have used drugs in the past year, 5) have smoked tobacco in the past 7 days, currently co-use or have a past history of cannabis use, and/or 6) self-report a mental illness. Participation will be entirely voluntary. Community-based researchers will conduct recruitment by working with Operation Come Home and Bridge staff to assess youth and/or adults, who meet the eligibility criteria, and have an interest in participating upon receiving relevant study information (i.e. risks, benefits, remuneration, etc.), which will be provided verbally by the peer researchers or in written form on a study consent document. Upon enrolment, peer researchers will then provide an appointment time for Phase 1 study data collection. All those who are enrolled to participate in the study will be provided with consent forms to assent their own participation.
Peer researchers will administer a one-time questionnaire about their cannabis use and how it relates to their physical and mental health. Some of those participants that co-use tobacco and marijuana and self-report a mental health illness will be invited to participate in a semi-structured interview to collect further data about their smoking and drug use (type of use, frequency of use, etc.), place of access, and facilitators and barriers to use. Participants will receive a $50 cash honorarium as compensation for their participation. Qualitative data will also be collected informally from social support workers and other key informants at Operation Come Home to gain a better understanding of tobacco/drug use patterns among youth, their progress upon joining Operation Come Home, drivers to join the program, and how the issue of addiction(s) affects the youth and their education/job status, mental health, social networks, quality of life, etc.
Understanding specific details from this phase about youth and adult smoking and concurrent illicit drug use will allow peer researchers to develop a more accurate hypothesis and potentially modify qualitative interview questions (from the PROMPT project) that will be asked on a monthly basis during the intervention.
Recruited participants can partake in the two following optional methods:
- Photovoice: 20 recruited participants will be trained on how to use Photovoice.
- Duoethnographic Dialogue: Ten interested Photovoice participants will be invited to be paired one-on-one with an adult-aged (aged 27+) participant of the MHCC OCM project.
Setting: 1) The Bridge Engagement Centre, Ottawa; and 2) Operation Come Home, Ottawa
Expertise: The PI is well versed in community-based research. Dr. Pakhale led the PROMPT project, a community-based smoking cessation project engaging a similar target population. Partnering with Operation Come Home and Ms. Elspeth McKay, the Executive Director of Operation Come Home, provides the PI with expert experience in engaging this marginalized youth population. Together, the team is very experienced in substance dependence and the target population. The investigators collective expertise with links to the target community will support the implementation of the trial.
Outcomes: 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 designing and implementing effective programs to treat substance dependence in marginalized youth populations.
- Conditions
- Tobacco Use, Substance Use, Cannabis Use
- Medical subject headings
- Tobacco Use, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Photovoice | Three youth community peer researchers from marginalized communities will be recruited and involved in every aspect of the project. We will recruit 20 participants from marginalized communities with a current or past history of cannabis use, who can speak English, and who are between 16 and 26 years old. Participants will receive training on study procedures, basics of photography and disposable camera to document their experiences with mental health and substance use over the span of two weeks. Community peer researchers and research team will conduct photoanalysis and creation of the description of the five photos chosen by each participant. Duoethnographic dialogue: 10 youth participants will be paired with an older participant of TCAY study to have an open discussion to explore their experiences with cannabis and mental health. This conversation will be facilitated by community peer researcher, recorded and transcribed verbatim. | |
| Mix-method community based participatory action research | Phase 1 study: 300 participants will be invited to participate in a one-time questionnaire. Consequently, up to 25 of those participants will be invited to participate in semi-structured interviews. Data from the participants and literature will then be triangulated, coded, and analyzed using NVivo software. Researchers will transcribe interviews, create a code guide, code, analyze and report the data to appropriately inform the intervention (Phase 2). Phase 2: 6 month follow-up with a questionnaire focused on socio-demographic data, questions on participants' smoking and other substance use habits, mental health, as well as questions on participants' social networks.. Participants will be informed that they can skip any of the questions if they are uncomfortable answering them. Qualitative data will be analyzed using NVivo, and quantitative data will be analyzed using SAS or R software. Phase 2 findings will be reported and submitted to an appropriate peer-review journal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the frequency of tobacco and other drug use
Understand the problem of substance use and addiction among youth between the ages of 16 years or older who are homeless or insecurely housed (as defined-by project step) in Downtown Ottawa, and who attend programs at project step partner, OCH
Measured: 6 Months
Tobacco and other drug use reduction
Design and deliver an individualized intervention (6 months) to help at-risk youth decrease concurrent poly-substance use.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Operation Come Home
- Responsible party
- Sponsor
- Investigators
- Smita Pakhale, M.D., Principal investigator, Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812613
- Sponsor's protocol ID
- 20180595-01H
- Acronym
- TCAY-Ottawa
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2019
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
- Tobacco Concurrent Addictions in At-Risk Youth in Ottawa: A Mixed Methods Community-Based Participatory Action Research Project (TCAY- Ottawa)
- ClinicalTrials.gov ID
- NCT04812613
- Acronym / sponsor ID
- TCAY-Ottawa / 20180595-01H
- Conditions
- Tobacco Use, Substance Use, Cannabis Use
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Operation Come Home
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Mar 2021 (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.
According to the 2015 Ontario Student Drug Use and Health Survey (OSDUHS), there has been a significant increase in the number of secondary school youth who use poly-substances. Not all youth have the same risk for problematic substance use. Health literature documents a high level of comorbidity between mental health and substance use, which is exacerbated in homeless youth populations. Therefore, the proposed study will focus on understanding poly-substance use among at-risk homeless school youth. As seen in substance use research and the PROMPT (2016) study (Participatory Research in Ottawa: Management and Point-of-Care for Tobacco Dependence, PI: Dr. Smita Pakhale), reduction and quitting of one substance (tobacco smoking) can lead to the reduction and quitting of other poly-substance use. A Community-Based Participatory Action Research (CBPAR) approach can help at-risk youth feel safe and comfortable enough to provide personal information about their poly-substance use and engagement with treatment or harm reduction programs. This project will be a first step in increasing health equity among at-risk homeless youth in Downtown Ottawa. The investigators aim to follow a group of at-risk youth to while providing an appropriately modified PROMPT intervention, including peers support and a licensed mental health and substance use nurse.
Detailed description
Part 1: Youth and Polysubstance Use This study aims to expand the reach of the existing PROMPT intervention operationalized at the Bridge for vulnerable polysubstance using youth who smoke tobacco. The peer-led PROMPT intervention aims to reduce rates of tobacco smoking and poly-substances use among populations who are homeless or at-risk for homelessness.
Research Objectives:
Understand the positive and negative experiences of cannabis use, the effect of cannabis use on mental health, and recognize the patterns of cannabis use between different generations among marginalized populations with a disproportionate burden of mental illness. Additionally, use meaningful qualitative methods to encourage storytelling and authentic sharing of individual experiences of cannabis use and mental health.
Sub-objectives: 1) Identify trends in tobacco and poly-substance use among at-risk youth in Ottawa. Surveys and interview guides have been created with the intention of understanding the root cause of tobacco and poly-substance use among at-risk youth who attend alternative schooling, their perception of tobacco/drug use, types of tobacco and drug use that are most prevalent among these youth, and where youth access tobacco and other substances.
- Appropriately modify and implement the peer-led PROMPT intervention for 20 youth recruited into the program. The peer-led intervention includes free access to nurse counselling and support on homelessness, addictions, and mental health. You will also access a safe and non-judgemental space for one-to-one peer support. Modifications to this intervention will be dependent on the findings from data collected in the first phase of the study (sub-objective 1).
- Upon completion of the research project, a manuscript will be submitted for publication in a peer-reviewed, open access journal, and various knowledge translation initiatives (e.g., infographics, seminars, etc.) will be undertaken to ensure that study findings are meaningfully available to organizations that serve at-risk youth who smoke tobacco and/or use poly-substances.
- Compare healthcare utilization (ER visits and hospitalizations) over one year after the study by linking the trial data to health administrative data available at the Institute for Clinical and Evaluative Sciences (ICES).
Part 2: Tobacco, Cannabis, and Mental Health Marginalized groups, such as polysubstance using street-involved, homeless, and/or racialized individuals, have been overlooked by studies that investigated the causal relationship between cannabis and mental health. As a result, a paucity of data exists on the motives and reasons that influence cannabis use in these populations, and their potential impact on mental health. This knowledge gap is concerning as marginalized groups experience disproportionate rates of mental illness, and due to social and structural inequities are more likely to abuse drugs, including cannabis, relative to the general population. Therefore, the unique experiences of this population should be investigated to further our understanding on the relationship between polysubstance use, cannabis, and mental health.
In marginalized communities, patterns of cannabis use, including type, duration, and frequency of use, may mediate the mental health effects of cannabis. While recreational cannabis is legal in Canada, marginalized populations may have limited access to Ontario's legal cannabis retailers. As a result, individuals may seek illegal or 'street' cannabis, which may be combined with other illicit drugs and/or tobacco that could influence mental health. Therefore, patterns of cannabis consumption, and the source of cannabis, should be evaluated in relation to mental health.
In light of the above, we propose the use of mixed methods to investigate the lived experience of people with mental illness, risk for cardiovascular disease, and current or past history of cannabis use. Cannabis use is a modifiable risk factor for poor mental health and cardiovascular disease. Using a qualitative focus group approach, we will prospectively explore patterns of cannabis use, tobacco use/other substance use, and their impact on mental health (e.g., depression, anxiety) and physical health (risk factors for cardiovascular disease). Using a quantitative survey, we will quantify the substance use (cannabis and other substance use), physical and mental health, and the prevalence of cardiovascular disease risk factors. The study will be carried out in conjunction with The Bridge Engagement Centre (The Bridge), which has over six years of Community Based Participatory Research (CBPR) experience with marginalized communities, including: people experiencing homeless or at-risk of homelessness, People Who Use Drugs (PWUD), racialized populations, and Indigenous peoples.
Research Objectives:
Objective 1: To understand perceptions, beliefs, cultural practices, and factors that influence cannabis use among marginalized populations with a disproportionate burden of mental illness.
Objective 2: To explore positive and negative experiences of cannabis use in marginalized populations with a disproportionate burden of mental illness.
Objective 3: To understand patterns of cannabis use from adolescence to adulthood and its perceived relationship to mental health in marginalized populations with mental illness.
Objective 4: To understand patterns of cannabis use and its effect on mental health in marginalized populations.
Objective 5: To understand different patterns of cannabis use and its effect on mental health in marginalized populations, specifically looking at youth and adult experiences simultaneously.
Objective 6: To use qualitative methods to encourage storytelling and authentic sharing of individual experiences of mental health and cannabis use among youth populations.
Objective 7: To quantify the prevalence of cardiovascular risk factors among marginalized populations with a cannabis use disorder and poor mental health.
Objective 8: To co-produce knowledge on cardiovascular disease prevention strategies for marginalized populations that use cannabis and report poor mental health.
Study Design:
Phase 1: will involve gathering information on the root causes or facilitators of poly-substance use among at-risk youth, the types of drug use that is most prevalent among at-risk youth, and the early and ongoing points of access to licit and illicit substances.
Phase 2: will involve a single arm prospective cohort study looking to tackle poly-substance use in marginalized youth by providing an individualized, youth-tailored (i.e. based on qualitative results obtained in phase I), social-based intervention with optional access to a licensed mental health and substance use nurse counselling.
A team of community-based (peer) researchers will enroll 20 youth and 500 adult and youth (16 years and older) participants from Operation Come Home and the Bridge, respectively using iPads for the proposed TCAY-Ottawa study. Participants will be eligible if they: 1) are currently living in Ottawa for at least 3 months prior to enrolment, 2) are homeless or insecurely housed (from Operation Come Home and the Bridge), 3) 16 years or older, 4) have used drugs in the past year, 5) have smoked tobacco in the past 7 days, currently co-use or have a past history of cannabis use, and/or 6) self-report a mental illness. Participation will be entirely voluntary. Community-based researchers will conduct recruitment by working with Operation Come Home and Bridge staff to assess youth and/or adults, who meet the eligibility criteria, and have an interest in participating upon receiving relevant study information (i.e. risks, benefits, remuneration, etc.), which will be provided verbally by the peer researchers or in written form on a study consent document. Upon enrolment, peer researchers will then provide an appointment time for Phase 1 study data collection. All those who are enrolled to participate in the study will be provided with consent forms to assent their own participation.
Peer researchers will administer a one-time questionnaire about their cannabis use and how it relates to their physical and mental health. Some of those participants that co-use tobacco and marijuana and self-report a mental health illness will be invited to participate in a semi-structured interview to collect further data about their smoking and drug use (type of use, frequency of use, etc.), place of access, and facilitators and barriers to use. Participants will receive a $50 cash honorarium as compensation for their participation. Qualitative data will also be collected informally from social support workers and other key informants at Operation Come Home to gain a better understanding of tobacco/drug use patterns among youth, their progress upon joining Operation Come Home, drivers to join the program, and how the issue of addiction(s) affects the youth and their education/job status, mental health, social networks, quality of life, etc.
Understanding specific details from this phase about youth and adult smoking and concurrent illicit drug use will allow peer researchers to develop a more accurate hypothesis and potentially modify qualitative interview questions (from the PROMPT project) that will be asked on a monthly basis during the intervention.
Recruited participants can partake in the two following optional methods:
- Photovoice: 20 recruited participants will be trained on how to use Photovoice.
- Duoethnographic Dialogue: Ten interested Photovoice participants will be invited to be paired one-on-one with an adult-aged (aged 27+) participant of the MHCC OCM project.
Setting: 1) The Bridge Engagement Centre, Ottawa; and 2) Operation Come Home, Ottawa
Expertise: The PI is well versed in community-based research. Dr. Pakhale led the PROMPT project, a community-based smoking cessation project engaging a similar target population. Partnering with Operation Come Home and Ms. Elspeth McKay, the Executive Director of Operation Come Home, provides the PI with expert experience in engaging this marginalized youth population. Together, the team is very experienced in substance dependence and the target population. The investigators collective expertise with links to the target community will support the implementation of the trial.
Outcomes: 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 designing and implementing effective programs to treat substance dependence in marginalized youth populations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photovoice | – | –Three youth community peer researchers from marginalized communities will be recruited and involved in every aspect of the project. We will recruit 20 participants from marginalized communities with a current or past history of cannabis use, who can speak English, and who are between 16 and 26 years old. Participants will receive training on study procedures, basics of photography and disposable camera to document their experiences with mental health and substance use over the span of two weeks. Community peer researchers and research team will conduct photoanalysis and creation of the description of the five photos chosen by each participant. Duoethnographic dialogue: 10 youth participants will be paired with an older participant of TCAY study to have an open discussion to explore their experiences with cannabis and mental health. This conversation will be facilitated by community peer researcher, recorded and transcribed verbatim. |
| Mix-method community based participatory action research | – | –Phase 1 study: 300 participants will be invited to participate in a one-time questionnaire. Consequently, up to 25 of those participants will be invited to participate in semi-structured interviews. Data from the participants and literature will then be triangulated, coded, and analyzed using NVivo software. Researchers will transcribe interviews, create a code guide, code, analyze and report the data to appropriately inform the intervention (Phase 2). Phase 2: 6 month follow-up with a questionnaire focused on socio-demographic data, questions on participants' smoking and other substance use habits, mental health, as well as questions on participants' social networks.. Participants will be informed that they can skip any of the questions if they are uncomfortable answering them. Qualitative data will be analyzed using NVivo, and quantitative data will be analyzed using SAS or R software. Phase 2 findings will be reported and submitted to an appropriate peer-review journal. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 20 youth and 500 adult participants
Key inclusion criteria (5 listed)
- Are currently living in Ottawa for at least 3 months prior to enrolment.
- Are homeless or insecurely housed (from OCH and the Bridge).
- 16 years or older.
- currently use or have a past history of cannabis use
- Self-report a mental illness.
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Explore the frequency of tobacco and other drug use
Time frame: 6 Months
Understand the problem of substance use and addiction among youth between the ages of 16 years or older who are homeless or insecurely housed (as defined-by project step) in Downtown Ottawa, and who attend programs at project step partner, OCH
Tobacco and other drug use reduction
Time frame: 6 Months
Design and deliver an individualized intervention (6 months) to help at-risk youth decrease concurrent poly-substance use.
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: Yes
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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, M.D. principal investigator
Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Use and Substance Use, 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 1 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?
Explore the frequency of tobacco and other drug use (time frame: 6 Months). The study lists 2 primary outcomes in all. 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.