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Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis

6. juli 2026 opdateret af: Hannah Harris

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

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

Studieoversigt

Status

Ikke rekrutterer endnu

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

12

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40508
        • University Of Kentucky

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. English-speaking,
  2. Literate adults,
  3. Male or female,
  4. Between the ages of 18 and 55,
  5. Body Mass Index from 18.5 and 32.0 kg/m2,
  6. Able to provide written informed consent and perform all study procedures,
  7. 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,
  8. Past year history of vaporized or smoked cannabis use to intoxication,
  9. Past 30-day use of combusted tobacco,
  10. Not currently seeking treatment for cannabis, tobacco cigarettes, or other drug use,
  11. If female, a negative pregnancy test and use of an effective form of contraception during study participation (e.g., oral contraceptive, abstinence, barrier method),
  12. Negative urine drug test for drugs of abuse (other than cannabis) before every Laboratory Session, and
  13. 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:

  1. Physiologic drug dependence on opioids, benzodiazepines, barbiturates, and/or alcohol that would require medical management,
  2. 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]),
  3. Existing or significant lung health problems that could interfere with the study,
  4. Current or history of major psychiatric disorder that would limit the participant's ability to participate in the study (e.g., bipolar disorder),
  5. Exclusive use of tobacco or cannabis through vapes and Electronic Nicotine Delivery Systems (ENDS) products,
  6. Currently using daily prescription medications to manage medical conditions or any drug that could interfere with the study (as determined by the study physician),
  7. Clinically significant abnormal ECG (as determined by study physician/cardiologist),
  8. Clinically significant abnormal laboratory findings (e.g., liver function tests greater than 3x the upper limits of normal range),
  9. History of seizure disorder,
  10. Clinically significant history of head injuries requiring medical management or long-lasting sequelae.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Tobacco Cigarette
Participants will inhale a leading brand of tobacco cigarette (~1.0 gram; Marlboro Gold; Phillip Morris International).
A leading brand of tobacco cigarette (~1.0 gram; Marlboro Gold; Phillip Morris International)
Eksperimentel: Vaporized Cannabis (THC)
Participants will receive a non-therapeutic, active vaporized marijuana.
Active Cannabis (THC) will be inhaled.
Eksperimentel: Combustible Cannabis (THC)
Participants will receive a non-therapeutic, active smoked marijuana.
Active Cannabis (THC) will be inhaled.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exhaled Breath Condensate (EBC)
Tidsramme: 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.
Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration
Breath Volatile Organic Compound (BVOC)
Tidsramme: 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.
Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration
Exhaled Nitric Oxide (FeNO)
Tidsramme: 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.
Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cigarette Evaluation Questionnaire (CEQ)
Tidsramme: 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.
Immediately following administration of combusted tobacco or cannabis cigarette (approximately 10 minutes after drug administration)
Modified Cigarette Evaluation Questionnaire (mCEQ)
Tidsramme: 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.
Immediately following administration of vaporized cannabis (approximately 10 minutes after drug administration)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Hannah M Harris, Ph.D., University Of Kentucky

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

6. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Tobacco Cigarette

3
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