Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This outpatient study examines how inhaled cannabis, combustible or vaporized, alters lung health and breath biomarkers compared to a tobacco cigarette.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobacco Cigarette | Active Comparator | Participants will inhale a leading brand of tobacco cigarette (~1.0 gram; Marlboro Gold; Phillip Morris International). |
|
| Vaporized Cannabis (THC) | Experimental | Participants will receive a non-therapeutic, active vaporized marijuana. |
|
| Combustible Cannabis (THC) | Experimental | Participants will receive a non-therapeutic, active smoked marijuana. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis (THC) | Drug | Active Cannabis (THC) will be inhaled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately following administration of combusted tobacco or cannabis cigarette (approximately 10 minutes after drug administration) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul A Nuzzo, M.A. | Contact | 859-323-0002 | pnuzz2@email.uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hannah M Harris, Ph.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40508 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000072137 | Vaping |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C587251 | nabiximols |
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tobacco Cigarette | Drug | A leading brand of tobacco cigarette (~1.0 gram; Marlboro Gold; Phillip Morris International) |
|
| 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. | Immediately following administration of vaporized cannabis (approximately 10 minutes after drug administration) |
| D001523 |
| Mental Disorders |