Tobacco DependencePhase 1/2NCT05327660
CO Monitoring for Tobacco Cessation in Quitlines
A Phase 1/2 study testing Quitline Treatment as Usual (TAU), Remote Carbon Monoxide (CO) Monitoring and Incentivized Remote CO Monitoring in people with Tobacco Dependence, run by Consumer Wellness Solutions at 1 site in United States.
Trial summary
The present study is a 3-arm randomized controlled pilot study. Participants who call the Maryland Tobacco Quitline and are eligible for study participation are randomized to receive quitline tobacco cessation treatment as usual (TAU), TAU plus remote carbon monoxide (CO) monitoring via smartphone app, or TAU plus… 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
- What is being tested?
- Quitline Treatment as Usual (TAU), Remote Carbon Monoxide (CO) Monitoring and Incentivized Remote CO Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2021to 1 Nov 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Daily cigarette smokers calling into participating quitlines
- 18 year or older
- Reads and speaks English
- Has a smartphone with a data plan
- Willing to download and use study app
- Willing to use CO monitor
Who cannot join
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Optum Center for Wellbeing Research
Seattle, Washington, 98125
About this study
Official title: Remote Carbon Monoxide Monitoring and Incentives for Tobacco Cessation in Quitlines
The present study is a 3-arm randomized controlled pilot study. Participants who call the Maryland Tobacco Quitline and are eligible for study participation are randomized to receive quitline tobacco cessation treatment as usual (TAU), TAU plus remote carbon monoxide (CO) monitoring via smartphone app, or TAU plus remote carbon monoxide monitoring plus incentives vis smartphone app. The investigators hypothesize that remote CO monitoring will be feasible and acceptable to deliver in the quitline setting, will increase treatment engagement, and will increase tobacco cessation and treatment satisfaction rates.
- Conditions
- Tobacco Dependence
- Being tested
- Quitline Treatment as Usual (TAU), Remote Carbon Monoxide (CO) Monitoring, Incentivized Remote CO Monitoring
- Keywords
- tobacco cessation, tobacco quitlines, carbon monoxide monitoring, incentives
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quitline Treatment as Usual (TAU)Combination product
Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).
Remote Carbon Monoxide (CO) MonitoringCombination product
Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.
Incentivized Remote CO MonitoringCombination product
Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.
| Study group | Role | What they receive |
|---|---|---|
| Quitline treatment as usual (TAU) | Active comparator | Quitline services provided by participating state quitlines Receives: Combination Product: Quitline Treatment as Usual (TAU) |
| Quitline TAU plus remote CO monitoring | Experimental | Quitline service plus daily CO monitoring via a smartphone app Receives: Combination Product: Quitline Treatment as Usual (TAU); Combination Product: Remote Carbon Monoxide (CO) Monitoring |
| Quitline TAU plus incentivized remote CO monitoring | Experimental | Quitline TAU plus remote CO monitoring with small monetary incentives Receives: Combination Product: Quitline Treatment as Usual (TAU); Combination Product: Incentivized Remote CO Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction
Rating of satisfaction with quitline services on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the quitline services provided where low numbers (1-3) mean dissatisfaction and high numbers (4-6) mean satisfaction. Participants that reported a score of 4 (somewhat satisfied) or more are represented in the data table.
Measured: 60 days
Treatment Engagement
Number of quitline calls each participant engages in, collected via clinical record system.
Measured: 60 days
Self-reported Tobacco Abstinence
7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey
Measured: 60 days
Secondary outcomes (3)
Biochemically Verified Tobacco Abstinence
CO monitor reading 60 days post randomization (must be 7ppm or less to be considered abstinent) collected via smartphone app
Measured: 60 days
Engagement With CO Monitor
Number of times remote CO monitor is used collected via smartphone app.
Measured: 60 days
Satisfaction With CO Monitor
Satisfaction with CO monitor measures on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the CO monitor device and app where low numbers (1-3) mean dissatisfaction and high numbers (4-6) mean satisfaction. Participants that reported a score of 4 (somewhat satisfied) or more are represented in the data table.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start31 Dec 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consumer Wellness Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vincere Health, Maryland State Tobacco Quitline
- Responsible party
- Sponsor
- Investigators
- Kelly Carpenter, PhD, Principal investigator, Consumer Wellness Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327660
- Sponsor's protocol ID
- 2021-0056
- Status last verified
- Oct 2024
- First submitted
- 6 Apr 2022
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Carbon Monoxide Monitoring and Incentives for Tobacco Cessation in Quitlines
- ClinicalTrials.gov ID
- NCT05327660
- Acronym / sponsor ID
- 2021-0056
- Conditions
- Tobacco Dependence
- Keywords
- tobacco cessation, tobacco quitlines, carbon monoxide monitoring, incentives
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Consumer Wellness SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Vincere Health, Maryland State Tobacco Quitline
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is a 3-arm randomized controlled pilot study. Participants who call the Maryland Tobacco Quitline and are eligible for study participation are randomized to receive quitline tobacco cessation treatment as usual (TAU), TAU plus remote carbon monoxide (CO) monitoring via smartphone app, or TAU plus remote carbon monoxide monitoring plus incentives vis smartphone app. The investigators hypothesize that remote CO monitoring will be feasible and acceptable to deliver in the quitline setting, will increase treatment engagement, and will increase tobacco cessation and treatment satisfaction rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quitline treatment as usual (TAU) | Active comparator | Combination Product: Quitline Treatment as Usual (TAU)Quitline services provided by participating state quitlines |
| Quitline TAU plus remote CO monitoring | Experimental | Combination Product: Quitline Treatment as Usual (TAU), Combination Product: Remote Carbon Monoxide (CO) MonitoringQuitline service plus daily CO monitoring via a smartphone app |
| Quitline TAU plus incentivized remote CO monitoring | Experimental | Combination Product: Quitline Treatment as Usual (TAU), Combination Product: Incentivized Remote CO MonitoringQuitline TAU plus remote CO monitoring with small monetary incentives |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Daily cigarette smokers calling into participating quitlines
- 18 year or older
- Reads and speaks English
- Has a smartphone with a data plan
- Willing to download and use study app
Key exclusion criteria (1 listed)
- Pregnant or breast feeding
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 |
|---|---|---|
| Quitline Treatment as Usual (TAU)Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content). | Combination product | Quitline TAU plus incentivized remote CO monitoring, Quitline TAU plus remote CO monitoring, Quitline treatment as usual (TAU) |
| Remote Carbon Monoxide (CO) MonitoringRemote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor. | Combination product | Quitline TAU plus remote CO monitoring |
| Incentivized Remote CO MonitoringIncentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor. | Combination product | Quitline TAU plus incentivized remote CO monitoring |
Primary outcome
Treatment Satisfaction
Time frame: 60 days
Rating of satisfaction with quitline services on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the quitline services provided where low numbers (1-3) mean dissatisfaction and high numbers (4-6) mean satisfaction. Participants that reported a score of 4 (somewhat satisfied) or more are represented in the data table.
Treatment Engagement
Time frame: 60 days
Number of quitline calls each participant engages in, collected via clinical record system.
Self-reported Tobacco Abstinence
Time frame: 60 days
7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey
3 secondary outcomes
Biochemically Verified Tobacco Abstinence
Time frame: 60 days
Engagement With CO Monitor
Time frame: 60 days
Satisfaction With CO Monitor
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kelly Carpenter, PhD principal investigator
Consumer Wellness Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Quitline Treatment as Usual (TAU), Remote Carbon Monoxide (CO) Monitoring and Incentivized Remote CO Monitoring in people with Tobacco Dependence, run by Consumer Wellness Solutions at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 28 Oct 2024. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Satisfaction (time frame: 60 days). The study lists 3 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 28 Oct 2024.