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OpenTrials
Completed

NCT Number: NCT04826549

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

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rose Research Center, Charlotte, North Carolina, United States

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • Chronic opioid use.
  • Pregnant or nursing (by self-report) or positive urine pregnancy test.
  • Participant enrollment numbers met.

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Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. eRESEARCH APP VALIDATION

    Time frame: Daily for 5 days

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

Sponsors and collaborators

Lead sponsor

Rose Research Center, LLC

Industry

Collaborators

  • Foundation for a Smoke Free World INC

Registry information

Acronym: COCO

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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