- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07694466
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
Betingelser
Intervention / Behandling
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
- Navn: Paul A Nuzzo, M.A.
- Telefonnummer: 859-323-0002
- E-mail: pnuzz2@email.uky.edu
Studiesteder
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40508
- University Of Kentucky
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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:
- 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.
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 |
|---|---|
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Aktiv komparator: Tobacco Cigarette
Participants will inhale a leading brand of tobacco cigarette (~1.0 gram; Marlboro Gold; Phillip Morris International).
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A leading brand of tobacco cigarette (~1.0 gram; Marlboro Gold; Phillip Morris International)
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Eksperimentel: Vaporized Cannabis (THC)
Participants will receive a non-therapeutic, active vaporized marijuana.
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Active Cannabis (THC) will be inhaled.
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Eksperimentel: Combustible Cannabis (THC)
Participants will receive a non-therapeutic, active smoked marijuana.
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Active Cannabis (THC) will be inhaled.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Exhaled Breath Condensate (EBC)
Tidsramme: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration
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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.
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Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration
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Breath Volatile Organic Compound (BVOC)
Tidsramme: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration
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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.
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Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration
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Exhaled Nitric Oxide (FeNO)
Tidsramme: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration
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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.
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Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cigarette Evaluation Questionnaire (CEQ)
Tidsramme: Immediately following administration of combusted tobacco or cannabis cigarette (approximately 10 minutes after drug administration)
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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.
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Immediately following administration of combusted tobacco or cannabis cigarette (approximately 10 minutes after drug administration)
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Modified Cigarette Evaluation Questionnaire (mCEQ)
Tidsramme: Immediately following administration of vaporized cannabis (approximately 10 minutes after drug administration)
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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.
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Immediately following administration of vaporized cannabis (approximately 10 minutes after drug administration)
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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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 111900
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med Tobacco Cigarette
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US Department of Veterans AffairsAfsluttet
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Juul Labs, Inc.AfsluttetBrug af tobak | Tobaksrygning | Brug af elektronisk cigaret | Brug af cigaret, elektroniskForenede Stater
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Abramson Cancer Center at Penn MedicineNational Cancer Institute (NCI); New York University; Stanford UniversityAfsluttetRygning | Rygning, Tobak | Rygning, cigaretForenede Stater
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Stanford UniversityTobacco Related Disease Research ProgramTrukket tilbageOpførsel, sundhed | Adfærd, RygningForenede Stater
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IRCCS Azienda Ospedaliero-Universitaria di BolognaFondazione Salvatore MaugeriAfsluttet
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University of California, San FranciscoNational Institute on Drug Abuse (NIDA); National Institutes of Health... og andre samarbejdspartnereAfsluttet
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Medical University of ViennaUkendt
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Juul Labs, Inc.AfsluttetBrug af tobak | Tobaksrygning | Brug af elektronisk cigaret | Brug af cigaret, elektroniskForenede Stater
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Massachusetts General HospitalTrukket tilbageBrug af tobak | KOL
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St. Jude Children's Research HospitalNational Cancer Institute (NCI)Afsluttet