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Not yet recruiting NCT07694466

Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis

Early Phase I Interventional Cannabis Use Tobacco Biomarkers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cannabis (THC), Tobacco Cigarette.
Who it may be relevant to
Registry conditions: Cannabis Use, Tobacco, Biomarkers. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Lung Health and Breath Biomarkers: Acute Effects of Combusted and Vaporized Cannabis Inhalation Compared to Tobacco Cigarette Combustion in the Human Laboratory

Overview

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

Interventions

  • Drug Cannabis (THC)
    Active Cannabis (THC) will be inhaled.
  • Drug Tobacco Cigarette
    A leading brand of tobacco cigarette (\~1.0 gram; Marlboro Gold; Phillip Morris International)

Primary outcome measures

  • Exhaled Breath Condensate (EBC) [Time frame: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration]
  • Breath Volatile Organic Compound (BVOC) [Time frame: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration]
  • Exhaled Nitric Oxide (FeNO) [Time frame: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration]
Secondary outcome measures (2)
  • Cigarette Evaluation Questionnaire (CEQ) [Time frame: Immediately following administration of combusted tobacco or cannabis cigarette (approximately 10 minutes after drug administration)]
  • Modified Cigarette Evaluation Questionnaire (mCEQ) [Time frame: Immediately following administration of vaporized cannabis (approximately 10 minutes after drug administration)]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Kentucky — Lexington

Identifiers

NCT: NCT07694466 · 111900

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗