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

NCT04826549 | Completed

• 1 other identifier: COCO
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Smoking, Cigarette

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline

• eCO Monitor's agreement with the Vitalograph BreathCO monitor

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

  Baseline

Secondary Outcomes (1)

• eRESEARCH APP VALIDATION

  Daily for 5 days

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rose Research Center, LLC: lead
• Foundation for a Smoke Free World INC: collaborator

Study Sites (2)

Rose Research Center

Charlotte, North Carolina, 28262, United States

Location

Rose Research Center

Raleigh, North Carolina, 27617, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: March 22, 2021
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)