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

Smoking, Cigarette Clinical Trial

— COCO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04826549
• Other study ID #: COCO
• Status: Completed
• Start date: March 22, 2021
• Est. completion date: October 27, 2021

Study information

• Verified date: January 2022
• Source: Rose Research Center, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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:

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. -

Related Conditions & MeSH terms

• Smoking, Cigarette

Locations

Country	Name	City	State
United States	Rose Research Center	Charlotte	North Carolina
United States	Rose Research Center	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Rose Research Center, LLC	Foundation for a Smoke-Free World

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	eCO Monitor's agreement with the Vitalograph BreathCO monitor	Comparing the CO values from the eCO Monitor and the Vitalograph BreathCO monitor.	Baseline
Secondary	eRESEARCH APP VALIDATION	Validate a new mobile app called eResearch through specific functionality testing by study participants.	Daily for 5 days