Health TrialsbyHealthPanel

Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis

ConditionsCannabis UseTobaccoBiomarkers
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHannah Harris

About this trial

This outpatient study examines how inhaled cannabis, combustible or vaporized, alters lung health and breath biomarkers compared to a tobacco cigarette.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

English-speaking,

Literate adults,

Male or female,

Between the ages of 18 and 55,

Disqualifiers

Physiologic drug dependence on opioids, benzodiazepines, barbiturates, and/or alcohol that would require medical management,

Clinically significant acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders [e.g., asthma, COPD]),

Existing or significant lung health problems that could interfere with the study,

Current or history of major psychiatric disorder that would limit the participant's ability to participate in the study (e.g., bipolar disorder),

Trial design

Design model

Crossover

Treatments tested in this trial

  • Cannabis (THC)

    Drug

    Active Cannabis (THC) will be inhaled.

  • Tobacco Cigarette

    Drug

    A leading brand of tobacco cigarette (\~1.0 gram; Marlboro Gold; Phillip Morris International)

Treatment groups

12 Participants
are divided into 3 treatment groups
Group A: Tobacco CigaretteActive comparator 1 intervention
Group B: Vaporized Cannabis (THC)Experimental treatment 1 intervention
Group C: Combustible Cannabis (THC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Exhaled Breath Condensate (EBC)

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
2

Breath Volatile Organic Compound (BVOC)

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
3

Exhaled Nitric Oxide (FeNO)

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
Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration

Secondary outcomes

1

Cigarette Evaluation Questionnaire (CEQ)

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 combusted tobacco or cannabis cigarette (approximately 10 minutes after drug administration)
2

Modified Cigarette Evaluation Questionnaire (mCEQ)

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.

Time frame
Immediately following administration of vaporized cannabis (approximately 10 minutes after drug administration)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hannah Harris

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov

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