Smoking, CigaretteCOCONCT04826549
A Comparison of Exhaled Carbon Monoxide Measurements Using the iCOquit Smokerlyzer and Vitalograph Breath CO Monitor vs Carboxyhemoglobin From Venous Samples While Validating a Mobile Research Application
An observational study of Smoking, Cigarette, run by Rose Research Center, LLC at 2 sites in United States.
Trial summary
The main objective of this study is to determine the accuracy and precision of the iCOquit Smokerlyzer as compared with the gold standard of COHb levels measured in venous plasma samples, as well as assessing its agreement with the Vitalograph BreathCO monitor. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Smoking, Cigarette
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2021to 27 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- Adult, Older adult
Study population: Combustible cigarette smokers from Raleigh, NC and Charlotte, NC and surrounding areas.
Who may be able to join
- Has signed the ICF and is able to read and understand the information provided in the ICF.
- Is 21 to 65 years of age (inclusive) at screening.
- No intention of quitting smoking in the next 30 days.
- Willing and able to comply with the requirements of the study.
- Owns a smartphone running iOS or Android with text message and data capabilities compatible with the eResearch app.
Who cannot join
- Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigators or designated medical staff based on all available assessments from the screening period (e.g., vital signs, physical examination, concomitant medications and medical history).
- PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts you would be better off dead, or of hurting yourself in some way") at screening.
- Body mass index (BMI) greater than 40.0 kg/m2
- Use of any of these products in the past 30 days:
- Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates),
- Experimental (investigational) drugs that are unknown to participant,
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- Chronic opioid use.
- Pregnant or nursing (by self-report) or positive urine pregnancy test.
- Participant enrollment numbers met.
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Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rose Research Center
Charlotte, North Carolina, 28262
Rose Research Center
Raleigh, North Carolina, 27617
About this study
The main objective of this study is to determine the accuracy and precision of the iCOquit Smokerlyzer as compared with the gold standard of COHb levels measured in venous plasma samples, as well as assessing its agreement with the Vitalograph BreathCO monitor. Validating the precision and accuracy of the iCOquit Smokerlyzer could establish an additional, less expensive, reliable method for determining smoking status in tobacco research. Additionally, the portability of the device would allow for remote biochemical verification of smoking status, thus enlarging the number of participants that can be included in intervention studies.
- Conditions
- Smoking, Cigarette
- Medical subject headings
- Cigarette Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
eCO Monitor Accuracy compared to COHb
Determine the accuracy and precision of the iCOquit Smokerlyzer as compared with the gold standard of COHb levels measured in venous plasma samples.
Measured: Baseline
eCO Monitor's agreement with the Vitalograph BreathCO monitor
Comparing the CO values from the eCO Monitor and the Vitalograph BreathCO monitor.
Measured: Baseline
Secondary outcomes (1)
eRESEARCH APP VALIDATION
Validate a new mobile app called eResearch through specific functionality testing by study participants.
Measured: Daily for 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start22 Mar 2021
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, CigaretteStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rose Research Center, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Foundation for a Smoke Free World INC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826549
- Sponsor's protocol ID
- COCO
- Acronym
- COCO
- Status last verified
- Jan 2022
- First submitted
- 26 Mar 2021
- Last updated
- 13 Jan 2022
- 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 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Exhaled Carbon Monoxide Measurements Using the iCOquit Smokerlyzer and Vitalograph Breath CO Monitor vs Carboxyhemoglobin From Venous Samples While Validating a Mobile Research Application
- ClinicalTrials.gov ID
- NCT04826549
- Acronym / sponsor ID
- COCO / COCO
- Conditions
- Smoking, Cigarette
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rose Research Center, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Foundation for a Smoke Free World INC
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 1 Apr 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.
The main objective of this study is to determine the accuracy and precision of the iCOquit Smokerlyzer as compared with the gold standard of COHb levels measured in venous plasma samples, as well as assessing its agreement with the Vitalograph BreathCO monitor. Validating the precision and accuracy of the iCOquit Smokerlyzer could establish an additional, less expensive, reliable method for determining smoking status in tobacco research. Additionally, the portability of the device would allow for remote biochemical verification of smoking status, thus enlarging the number of participants that can be included in intervention studies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Combustible cigarette smokers from Raleigh, NC and Charlotte, NC and surrounding areas.
Key inclusion criteria (5 listed)
- Has signed the ICF and is able to read and understand the information provided in the ICF.
- Is 21 to 65 years of age (inclusive) at screening.
- No intention of quitting smoking in the next 30 days.
- Willing and able to comply with the requirements of the study.
- Owns a smartphone running iOS or Android with text message and data capabilities compatible with the eResearch app.
Key exclusion criteria (10 listed)
- Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigators or designated medical staff based on all available assessments from the screening period (e.g., vital signs, physical examination, concomitant medications and medical history).
- PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts you would be better off dead, or of hurting yourself in some way") at screening.
- Body mass index (BMI) greater than 40.0 kg/m2
- Use of any of these products in the past 30 days:
- Pregnant or nursing (by self-report) or positive urine pregnancy test.
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
eCO Monitor Accuracy compared to COHb
Time frame: Baseline
Determine the accuracy and precision of the iCOquit Smokerlyzer as compared with the gold standard of COHb levels measured in venous plasma samples.
eCO Monitor's agreement with the Vitalograph BreathCO monitor
Time frame: Baseline
Comparing the CO values from the eCO Monitor and the Vitalograph BreathCO monitor.
1 secondary outcome
eRESEARCH APP VALIDATION
Time frame: Daily for 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, Cigarette, run by Rose Research Center, LLC at 2 sites 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 5 inclusion and 10 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
eCO Monitor Accuracy compared to COHb (time frame: Baseline). 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 13 Jan 2022.