Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis

NCT07694466 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 111900
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cannabis Use; Tobacco; Biomarkers

Keywords

vaping; cannabis; tobacco

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (2)

• Cigarette Evaluation Questionnaire (CEQ)

  Immediately following administration of combusted tobacco or cannabis cigarette (approximately 10 minutes after drug administration)

• Modified Cigarette Evaluation Questionnaire (mCEQ)

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

Study Arms (3)

Tobacco Cigarette

ACTIVE COMPARATOR

Participants will inhale a leading brand of tobacco cigarette (\~1.0 gram; Marlboro Gold; Phillip Morris International).

Drug: Tobacco Cigarette

Vaporized Cannabis (THC)

EXPERIMENTAL

Participants will receive a non-therapeutic, active vaporized marijuana.

Drug: Cannabis (THC)

Combustible Cannabis (THC)

EXPERIMENTAL

Participants will receive a non-therapeutic, active smoked marijuana.

Drug: Cannabis (THC)

Interventions

Cannabis (THC) DRUG

Active Cannabis (THC) will be inhaled.

Combustible Cannabis (THC); Vaporized Cannabis (THC)

Tobacco Cigarette DRUG

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

Tobacco Cigarette

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English-speaking,
• Literate adults,
• Male or female,
• Between the ages of 18 and 55,
• Body Mass Index from 18.5 and 32.0 kg/m2,
• Able to provide written informed consent and perform all study procedures,
• Current recreational cannabis users - must report past 30-day cannabis use and at least 5 exposures in the past year (minimum use criteria); no limit on maximum use,
• Past year history of vaporized or smoked cannabis use to intoxication,
• Past 30-day use of combusted tobacco,
• Not currently seeking treatment for cannabis, tobacco cigarettes, or other drug use,
• If female, a negative pregnancy test and use of an effective form of contraception during study participation (e.g., oral contraceptive, abstinence, barrier method),
• Negative urine drug test for drugs of abuse (other than cannabis) before every Laboratory Session, and
• Otherwise, healthy as determined by the investigator based on medical history, physical examination, vital signs, laboratory chemistries (blood chemistry with liver function tests and hematology, urinalysis, and microscopic evaluation, 12-lead electrocardiogram).

You may not qualify if:

• 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),
• Exclusive use of tobacco or cannabis through vapes and Electronic Nicotine Delivery Systems (ENDS) products,
• Currently using daily prescription medications to manage medical conditions or any drug that could interfere with the study (as determined by the study physician),
• Clinically significant abnormal ECG (as determined by study physician/cardiologist),
• Clinically significant abnormal laboratory findings (e.g., liver function tests greater than 3x the upper limits of normal range),
• History of seizure disorder,
• Clinically significant history of head injuries requiring medical management or long-lasting sequelae.

Sponsors & Collaborators

• Hannah Harris: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

MeSH Terms

Conditions

Vaping; Marijuana Abuse

Interventions

nabiximols; Dronabinol

Condition Hierarchy (Ancestors)

Smoking; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Hannah M Harris, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul A Nuzzo, M.A.

CONTACT

859-323-0002; pnuzz2@email.uky.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)