Tobacco SmokingVC-OMSCNCT06164678
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
A study testing OMSC in people with Tobacco Smoking and Vaping, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
This study aims to determine if a standardized approach including counselling and Nicotine Replacement Therapy (NRT) can help e-cigarette users quit vaping. Current e-cigarette users will be randomly assigned to either to counselling and NRT or counselling only group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking, Vaping
- What is being tested?
- OMSC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jul 2024to Dec 2026
- 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 of age or older
- Ontario resident
- Ability to speak English or French
- Regular use of e-cigarette (vaping at least once per week for the past four weeks)
Who cannot join
- Cognitive impairment or acute psychiatric illness that would alter their ability to participate
- Being institutionalized at a retirement home, nursing home or long-term care facility
- Participating in another smoking or vaping cessation program
- Allergy or intolerance to NRT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users: A Pilot RCT
This study aims to determine if a standardized approach including counselling and Nicotine Replacement Therapy (NRT) can help e-cigarette users quit vaping. Current e-cigarette users will be randomly assigned to either to counselling and NRT or counselling only group. Self-reported rates of vaping cessation will be measured throughout the year in both groups. The use of e-cigarettes has grown substantially among non-smokers, particularly among youth and young adults. These devices deliver high levels of nicotine, far greater than is possible with conventional cigarettes. Currently, they are not approved for smoking cessation or any purpose by Health Canada. Nonetheless, there is some evidence that e-cigarettes may be of assistance in smoking cessation. Conversely, there is evidence that using cigarettes and e-cigarettes together may result in increased cigarette consumption. E-cigarette use among youth also serves as a gateway to regular use of conventional cigarettes. Clinicians and patients are seeking guidance on vaping cessation. However, to date, there are no strong evidence-based interventions to support e-cigarette users in quitting. NRT is approved for smoking cessation by Health Canada. However, it is not approved for vaping cessation and thus its use to support e-cigarette users to quit by managing their nicotine withdrawal is considered "off-label". This represents a significant gap and opportunity, which this project will address.
The study hypothesizes that the OMSC approach, which includes the use of nicotine replacement therapy, will result in higher rates of vaping cessation compared to usual care.
Participants will all complete an initial counselling session to discuss vaping cessation and receive tips to help achieve cessation. They will all be asked to track their smoking/vaping behaviour and the amount of tobacco in their e-cigarette for 7 days. After 7 days, all participants will be randomly put into one of two groups (either the intervention or control group). They will have follow-up assessments with the research team at 1, 3, 6 and 12 months.
- Conditions
- Tobacco Smoking, Vaping
- Being tested
- OMSC
- Medical subject headings
- Tobacco Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMSCBehavioural
The OMSC program uses a counselling approach to assist clients with tobacco cessation. If required, nicotine replacement therapy may be offered.
| Study group | Role | What they receive |
|---|---|---|
| Ottawa Model for Smoking Cessation | Experimental | The OMSC group will receive counselling and pharmacotherapy if they choose (specifically NRT) with follow-up calls to support medication titration. Participants will be provided with quit cards, which are pre-loaded with $300 worth of funds that can only be used by the assigned study participant to purchase NRT (if they choose).
For those in the intervention group, the study counsellor who is a trained Nicotine Addiction Treatment Specialist (NATS) will facilitate follow-up, monitor NRT use, and advise participants to titrate NRT dose as required based on their minimum daily nicotine intake. These counselling calls will be conducted at day 3, 7, 14, 21, 30, 60, 90, and 180 as is standard in OMSC for people who smoke and are interested in quitting. A diary will also be provided to the participants to track their usage. Receives: Behavioral: OMSC |
| Usual Care | No intervention | The usual care group will receive the initial counselling session but no further follow-up or NRT. They will be able to self-initiate a follow-up call if they choose. Participants will not be excluded if they choose to initiate NRT on their own at their own expense. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaping Cessation
7-day point prevalence of vaping cessation measured at 3-months.
Measured: baseline to 3 months
Secondary outcomes (2)
Continuous Abstinence
Continuous abstinence rates at 1-day, 7-day, 1-month, 3-month, 6-month, and 12-month follow up.
Measured: 1-day, 7-day, 1-month, 3-month, 6-month, and 12-month from baseline date
Successful cessation
Self-reported cessation will be measured by a self-administered salivary cotinine test.
Measured: 12 month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start11 Jul 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies 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
- Parallel groups
- Model description
- Participants are randomized 1:1
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hassan Mir, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164678
- Sponsor's protocol ID
- 20230670-01H
- Acronym
- VC-OMSC
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2023
- Last updated
- 8 Sep 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users: A Pilot RCT
- ClinicalTrials.gov ID
- NCT06164678
- Acronym / sponsor ID
- VC-OMSC / 20230670-01H
- Conditions
- Tobacco Smoking, Vaping
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Dec 2023 (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.
This study aims to determine if a standardized approach including counselling and Nicotine Replacement Therapy (NRT) can help e-cigarette users quit vaping. Current e-cigarette users will be randomly assigned to either to counselling and NRT or counselling only group. Self-reported rates of vaping cessation will be measured throughout the year in both groups. The use of e-cigarettes has grown substantially among non-smokers, particularly among youth and young adults. These devices deliver high levels of nicotine, far greater than is possible with conventional cigarettes. Currently, they are not approved for smoking cessation or any purpose by Health Canada. Nonetheless, there is some evidence that e-cigarettes may be of assistance in smoking cessation. Conversely, there is evidence that using cigarettes and e-cigarettes together may result in increased cigarette consumption. E-cigarette use among youth also serves as a gateway to regular use of conventional cigarettes. Clinicians and patients are seeking guidance on vaping cessation. However, to date, there are no strong evidence-based interventions to support e-cigarette users in quitting. NRT is approved for smoking cessation by Health Canada. However, it is not approved for vaping cessation and thus its use to support e-cigarette users to quit by managing their nicotine withdrawal is considered "off-label". This represents a significant gap and opportunity, which this project will address.
The study hypothesizes that the OMSC approach, which includes the use of nicotine replacement therapy, will result in higher rates of vaping cessation compared to usual care.
Participants will all complete an initial counselling session to discuss vaping cessation and receive tips to help achieve cessation. They will all be asked to track their smoking/vaping behaviour and the amount of tobacco in their e-cigarette for 7 days. After 7 days, all participants will be randomly put into one of two groups (either the intervention or control group). They will have follow-up assessments with the research team at 1, 3, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| Ottawa Model for Smoking Cessation | Experimental | Behavioral: OMSCThe OMSC group will receive counselling and pharmacotherapy if they choose (specifically NRT) with follow-up calls to support medication titration. Participants will be provided with quit cards, which are pre-loaded with $300 worth of funds that can only be used by the assigned study participant to purchase NRT (if they choose). For those in the intervention group, the study counsellor who is a trained Nicotine Addiction Treatment Specialist (NATS) will facilitate follow-up, monitor NRT use, and advise participants to titrate NRT dose as required based on their minimum daily nicotine intake. These counselling calls will be conducted at day 3, 7, 14, 21, 30, 60, 90, and 180 as is standard in OMSC for people who smoke and are interested in quitting. A diary will also be provided to the participants to track their usage. |
| Usual Care | No intervention | –The usual care group will receive the initial counselling session but no further follow-up or NRT. They will be able to self-initiate a follow-up call if they choose. Participants will not be excluded if they choose to initiate NRT on their own at their own expense. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years of age or older
- Ontario resident
- Ability to speak English or French
- Regular use of e-cigarette (vaping at least once per week for the past four weeks)
Key exclusion criteria (4 listed)
- Cognitive impairment or acute psychiatric illness that would alter their ability to participate
- Being institutionalized at a retirement home, nursing home or long-term care facility
- Participating in another smoking or vaping cessation program
- Allergy or intolerance to NRT
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 |
|---|---|---|
| OMSCThe OMSC program uses a counselling approach to assist clients with tobacco cessation. If required, nicotine replacement therapy may be offered. | Behavioural | Ottawa Model for Smoking Cessation |
Primary outcome
Vaping Cessation
Time frame: baseline to 3 months
7-day point prevalence of vaping cessation measured at 3-months.
2 secondary outcomes
Continuous Abstinence
Time frame: 1-day, 7-day, 1-month, 3-month, 6-month, and 12-month from baseline date
Successful cessation
Time frame: 12 month assessment
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 8 Sep 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. This study is not recruiting at the moment.
Hassan Mir, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMSC in people with Tobacco Smoking and Vaping, run by Ottawa Heart Institute Research Corporation 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 4 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 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?
Vaping Cessation (time frame: baseline to 3 months). 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 8 Sep 2026.