Cannabis UseEarly Phase 1NCT07694466
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
A Early Phase 1 study testing Cannabis (THC) and Tobacco Cigarette in people with Cannabis Use and Tobacco, run by Hannah Harris at 1 site in United States.
Trial summary
This outpatient study examines how inhaled cannabis, combustible or vaporized, alters lung health and breath biomarkers compared to a tobacco cigarette. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Tobacco, Biomarkers
- What is being tested?
- Cannabis (THC) and Tobacco Cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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).
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Cannabis Use, Tobacco, Biomarkers
- Being tested
- Cannabis (THC), Tobacco Cigarette
- Keywords
- vaping, cannabis, tobacco
- Medical subject headings
- Vaping, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis (THC)Drug
Active Cannabis (THC) will be inhaled.
Tobacco CigaretteDrug
A leading brand of tobacco cigarette (~1.0 gram; Marlboro Gold; Phillip Morris International)
| Study group | Role | What they receive |
|---|---|---|
| Tobacco Cigarette | Active comparator | Participants will inhale a leading brand of tobacco cigarette (~1.0 gram; Marlboro Gold; Phillip Morris International). Receives: Drug: Tobacco Cigarette |
| Vaporized Cannabis (THC) | Experimental | Participants will receive a non-therapeutic, active vaporized marijuana. Receives: Drug: Cannabis (THC) |
| Combustible Cannabis (THC) | Experimental | Participants will receive a non-therapeutic, active smoked marijuana. Receives: Drug: Cannabis (THC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: Immediately following administration of combusted tobacco or cannabis cigarette (approximately 10 minutes after drug administration)
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.
Measured: Immediately following administration of vaporized cannabis (approximately 10 minutes after drug administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannah Harris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hannah Harris, University of Kentucky
- Investigators
- Hannah M Harris, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694466
- Sponsor's protocol ID
- 111900
- Status last verified
- Nov 2026
- First submitted
- 22 Jun 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Health and Breath Biomarkers: Acute Effects of Combusted and Vaporized Cannabis Inhalation Compared to Tobacco Cigarette Combustion in the Human Laboratory
- ClinicalTrials.gov ID
- NCT07694466
- Acronym / sponsor ID
- 111900
- Conditions
- Cannabis Use, Tobacco, Biomarkers
- Keywords
- vaping, cannabis, tobacco
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hannah HarrisUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This outpatient study examines how inhaled cannabis, combustible or vaporized, alters lung health and breath biomarkers compared to a tobacco cigarette.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tobacco Cigarette | Active comparator | Drug: Tobacco CigaretteParticipants will inhale a leading brand of tobacco cigarette (~1.0 gram; Marlboro Gold; Phillip Morris International). |
| Vaporized Cannabis (THC) | Experimental | Drug: Cannabis (THC)Participants will receive a non-therapeutic, active vaporized marijuana. |
| Combustible Cannabis (THC) | Experimental | Drug: Cannabis (THC)Participants will receive a non-therapeutic, active smoked marijuana. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis (THC)Active Cannabis (THC) will be inhaled. | Drug | Combustible Cannabis (THC), Vaporized Cannabis (THC) |
| Tobacco CigaretteA leading brand of tobacco cigarette (~1.0 gram; Marlboro Gold; Phillip Morris International) | Drug | Tobacco Cigarette |
Primary outcome
Exhaled Breath Condensate (EBC)
Time frame: 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.
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
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.
Exhaled Nitric Oxide (FeNO)
Time frame: 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.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hannah M Harris, Ph.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cannabis (THC) and Tobacco Cigarette in people with Cannabis Use and Tobacco, run by Hannah Harris at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul A Nuzzo, M.A. (859-323-0002, pnuzz2@email.uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled Breath Condensate (EBC) (time frame: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.