CClinicalTrials.gg
CompletedNCT04826549COCOUpdated Jan 13, 2022

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 in Smoking, Cigarette, sponsored by Rose Research Center, LLC. Completed at 2 sites in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Rose Research Center, LLC · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
21 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Smoking, Cigarette
03

In context

Lead sponsor

Rose Research Center, LLC is the lead sponsor of 13 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Combustible cigarette smokers from Raleigh, NC and Charlotte, NC and surrounding areas.

Inclusion criteria

  1. Has signed the ICF and is able to read and understand the information provided in the ICF.
  2. Is 21 to 65 years of age (inclusive) at screening.
  3. No intention of quitting smoking in the next 30 days.
  4. Willing and able to comply with the requirements of the study.
  5. Owns a smartphone running iOS or Android with text message and data capabilities compatible with the eResearch app.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. 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.
  3. Body mass index (BMI) greater than 40.0 kg/m2
  4. Use of any of these products in the past 30 days:

    1. Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates),
    2. Experimental (investigational) drugs that are unknown to participant,
    3. Chronic opioid use.
  5. Pregnant or nursing (by self-report) or positive urine pregnancy test.
  6. Participant enrollment numbers met.

    -

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. eCO Monitor's agreement with the Vitalograph BreathCO monitor

    Comparing the CO values from the eCO Monitor and the Vitalograph BreathCO monitor.

    Time frame: Baseline

Secondary outcomes

  1. eRESEARCH APP VALIDATION

    Validate a new mobile app called eResearch through specific functionality testing by study participants.

    Time frame: Daily for 5 days

07

Study locations

2 sites
  • Rose Research Center
    Charlotte, North Carolina 28262, United States
  • Rose Research Center
    Raleigh, North Carolina 27617, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04826549
Lead sponsor
Rose Research Center, LLC
Collaborators
Foundation for a Smoke Free World INC
Responsible party
Sponsor
First posted
Apr 1, 2021
Start date
Mar 22, 2021
Primary completion
Oct 27, 2021
Completion
Oct 27, 2021
Last update
Jan 13, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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