University of Kentucky
Lexington, Kentucky, 40508, United States
NCT Number: NCT07694466
This outpatient study examines how inhaled cannabis, combustible or vaporized, alters lung health and breath biomarkers compared to a tobacco cigarette.
Trial opening soon.
Get Notified18 year–55 year
All sexes
Interventional
Early Phase 1
Lexington, Kentucky, 40508, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active Cannabis (THC) will be inhaled.
A leading brand of tobacco cigarette (~1.0 gram; Marlboro Gold; Phillip Morris International)
Time frame: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration
To capture Exhaled Breath Condensate (EBC) samples, the participant will inhale and exhale normally through an RTube device for ~10 minutes. The RTube will separate saliva from the main exhaled stream in the blue "Tee" section of the mouthpiece. The exhaled stream passes through a one-way duckbill valve into a gray condensation tube. Samples can be analyzed using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). The primary outcome of this measure is the identification of metals, proteins, as well as non-volatiles present before and after drug administration conditions.
Time frame: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration
For this test, participants will place the ReCIVA Breath Sampler device over their nose and mouth for ~15 minutes and breathe normally. Exhaled breath volatile organic compounds (BVOC) are collected on Breath Biopsy Cartridges and can be analyzed using Thermal Desorption-Gas Chromatography-Mass Spectrometry (TD-GC-MS) to identify over 200 volatile organic compound (VOC) biomarkers. The primary outcome of this measure is the identification of BVOC biomarkers present before and after drug administration conditions.
Time frame: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration
Elevated FeNO levels serve as a biomarker for airway inflammation. To measure this, the NIOX VERO FeNO device will be used. Participants will insert the NIOX mouthpiece into their mouth and be instructed to inhale through the device and, when prompted, exhale for ~10 seconds. The primary outcome of this measure is the level of FeNO present before and after drug administration conditions.
Time frame: Immediately following administration of combusted tobacco or cannabis cigarette (approximately 10 minutes after drug administration)
Immediately following drug administration of tobacco or cannabis cigarettes, participants are to rate each cigarette on a scale from 0 'Not at all' to 7- 'Extremely' for questions on satisfaction, similarity to usual brand, psychological reward, aversion, enjoyment of respiratory sensations, and perceived strength.
Time frame: Immediately following administration of vaporized cannabis (approximately 10 minutes after drug administration)
Immediately following drug administration of vaped cannabis, each participant will rate vaped cannabis on a 7-point response scale of 0 - 'Not at all' to 7- 'Extremely' for questions on satisfaction, similarity to usual brand, psychological reward, aversion, and enjoyment of respiratory sensations.
Contact information is provided by the study sponsor or research team.
Hannah Harris
Other
Lung Health and Breath Biomarkers: Acute Effects of Combusted and Vaporized Cannabis Inhalation Compared to Tobacco Cigarette Combustion in the Human Laboratory
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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