Status:
COMPLETED
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
Lead Sponsor:
Rose Research Center, LLC
Collaborating Sponsors:
Foundation for a Smoke Free World INC
Conditions:
Smoking, Cigarette
Eligibility:
All Genders
21-65 years
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
March 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 27 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04826549
Start Date
March 22 2021
End Date
October 27 2021
Last Update
January 13 2022
Active Locations (2)
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1
Rose Research Center
Charlotte, North Carolina, United States, 28262
2
Rose Research Center
Raleigh, North Carolina, United States, 27617