Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream

Launched by ROSWELL PARK CANCER INSTITUTE · Mar 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how vaping THC, the active ingredient in cannabis, affects the body, especially when nicotine is involved. Researchers want to understand how THC from vaping gets into the bloodstream compared to smoking cannabis, which is the most common way people use it. This study aims to gather important safety information about vaping THC products, especially since there has been a lot of discussion about the safety of vaping in recent years.

To participate in this trial, you need to be at least 21 years old and have used THC vaping products regularly for at least three months. You'll also need to have experience using nicotine vapes. Participants will go through several tests to ensure they meet the study's requirements and will need to avoid cannabis and nicotine for a certain period before each session. If you join, you can expect to learn more about how vaping THC works in your body and contribute to important research on cannabis use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 21 years of age; (self-reported on screening, verified at study visit).
• • Report use of commercial THC vaping cartridges for at least 3 months prior to enrollment; (self-reported).
• • Experience with THC potency at or above the study product AND experience with chasing THC with nicotine (at least monthly); (self-reported).
• • Report use of THC vaping liquids at least weekly (4x/month); (self-reported).
• • Daily use of nicotine vaping products containing 5% nicotine for at least 3 months prior to enrollment; (self-reported).
• • Report of not currently trying to become pregnant (females). Women of childbearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures.
• • Willing to complete a THC saliva test to check for recent use (NarcoCheck Ref#: NCE-STHC-1), semi-quantitative urinary THCA rapid test (NarcoCheck® THC Pre Dosage), and an illicit drug urine test (NarcoCheck® Évolutive®) during baseline testing, prior to receiving any study-related products.
• • Negative THC saliva test (NarcoCheck Ref#: NCE-S-THC-1), detection level 1-3 on urinary THCA rapid test (NarcoCheck® THC PreDosage), and illicit drug screen negative for all drugs except THC (NarcoCheck® Évolutive®).
• • Willing to abstain from nicotine use for 8 hours prior to each study session and abstain from cannabis use 7 days prior to each session.
• • Participant must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
• Exclusion Criteria:
• • Detection level 4-5 (\> 300 ng/mL) on urinary THCA rapid test (NarcoCheck® THC PreDosage Ref#: DOA-M03-9B) and a positive result on THC saliva test (NarcoCheck Ref#: NCE-S-THC-1).
• • Illegal or non-prescription drug use within the past 90 days. As detected by NarcoCheck® Évolutive® (detection in human urine of the 12 most currently abused drugs) at the first session and prior to receiving any study product. THC use detected by NarcoCheck® Évolutive® is permitted
• • Illegal or non-prescription drug use/alcohol substance use disorder (SUD) within the past year; (self-reported).
• • Report 2 or more drinking occasions/week with 4 or more drinks/occasion; (self-reported).
• • Report of daily cigarette use; (self-reported).
• • Current or prior diagnosis of schizophrenia, bipolar disorder, or other severe psychotic mental illness; (self-reported).
• • Current or prior diagnosis of myocardial infarction, arrhythmia, or congestive heart failure (self-reported).
• • Current or prior cancer diagnosis.
• • Pregnant, currently trying to become pregnant, or breastfeeding (females); (self-reported; pregnancy validated on study visit by urine test).
• • Regular use of medications that contain nicotine, induce CYP2A6, stimulants, or sympatholytics (e.g., beta-blockers); (self-reported).
• • Unwilling or unable to follow protocol requirements.
• • Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for participation.
• * The following special populations will be excluded:
• • Cognitively impaired adults/adults with impaired decision-making capacity
• • Individuals who are not yet adults (infants, children, teenagers)
• • Pregnant women
• • Prisoners
• • No children or person under the age of 21 will be involved in the study. While those under 21 may use cannabis smoked or vaping products, the legal age of purchasing and using those products in New York State is 21. The current legal age to purchase and use tobacco products in New York State (NYS) is 21. Thus, our provision of study product to adults aged 21 and older is in line with current NYS law.