THC Vaping Liquids for Cannabis Use

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Roswell Park Cancer Institute

Must not be taking: Nicotine, CYP2A6 inducers, Stimulants, Sympatholytics

Disqualifiers: Schizophrenia, Bipolar, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Up to 21 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how THC, the active compound in cannabis, enters the bloodstream when vaped, particularly when nicotine vapes are used before or after. The goal is to compare THC delivery from vaping with traditional smoking methods to better understand the safety and effects of vaping THC. Participants must have used THC vaping products weekly and nicotine vapes daily for at least three months. As an Early Phase 1 trial, this research focuses on understanding how the body processes THC, offering participants a chance to contribute to foundational knowledge in cannabis research.

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those who regularly use medications containing nicotine, CYP2A6 inducers, stimulants, or sympatholytics (like beta-blockers). You should discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that vaping THC liquids might produce fewer harmful chemicals than smoking cannabis, potentially making vaping a less harmful option. However, vaping has links to serious lung illnesses and even some deaths, often due to certain vaping products. THC vapes can contain very high levels of THC, sometimes exceeding 95%, and may also include other harmful ingredients. For example, some flavorings in e-liquids have been found toxic to the lungs and heart.

At this early stage of the trial, researchers are primarily assessing the treatment's safety and participants' tolerance. Only a few individuals have tried the treatment so far, so limited safety information is available. While the prospect of fewer chemicals is promising, caution is necessary due to the risks associated with vaping. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about THC vaping liquids for cannabis use because they offer a novel delivery method that could potentially enhance the precision and control of THC consumption. Unlike traditional forms of cannabis use, such as smoking or edibles, vaping allows for rapid onset and adjustable dosing, which might help in managing cannabis use more effectively. This method could lead to reduced risks associated with smoking while providing a more consistent experience compared to edibles, where the effects can be unpredictable and delayed. By studying these different vaping combinations, researchers hope to better understand how to optimize THC delivery for therapeutic use, potentially offering a safer and more controlled option for users.

What evidence suggests that this trial's treatments could be effective?

This trial will explore the effects of THC vaping liquids, with participants experiencing different combinations of placebo, THC, and nicotine across various sessions. Studies have shown that vaping THC might be safer than smoking cannabis. Specifically, one study found that people who switched from smoking to vaping cannabis had healthier lungs, with better breathing and fewer respiratory issues. Research indicates that vaping THC is becoming more popular, especially among young people in the U.S. This trend might be due to the perception that vaping is less harmful than smoking. While more data is still being collected on THC delivery through vaping, current evidence suggests that vaping can effectively introduce THC into the bloodstream, possibly offering a safer method of use. ^{6 7 8 9 10}

Who Is on the Research Team?

Danielle M Smith

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals who are experiencing cannabis dependence or abuse. Participants should be current users of THC products and willing to use vaping devices in a controlled setting. The study excludes those with health conditions that may interfere with the trial's procedures or outcomes.

Inclusion Criteria

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

I have used THC vaping cartridges for over 3 months.

I use THC vaping liquids at least once a week.

Exclusion Criteria

Illegal or non-prescription drug use within the past 90 days as detected by NarcoCheck® Évolutive® at the first session and prior to receiving any study product. THC use detected by NarcoCheck® Évolutive® is permitted

I have been diagnosed with cancer before or currently have it.

Pregnant, currently trying to become pregnant, or breastfeeding (females) (self-reported; pregnancy validated on study visit by urine test)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 3 vaping sessions with different sequences of nicotine and THC, separated by 7-14 days

Up to 21 days

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• THC Vaping Liquids

Trial Overview The study investigates how using nicotine vapes before or after THC affects THC levels in the blood. It involves collecting biospecimens, administering nicotine, placebo, questionnaires, and Cannabis sativa extract to understand these effects compared to smoking cannabis.

How Is the Trial Designed?

Group I: Arm C (placebo, THC, nicotine) Experimental Treatment 5 Interventions

Participants complete 3 vaping sessions separated by 7-14 days on study: * VISIT 1: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. * VISIT 2: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. * VISIT 3: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. All participants also undergo blood sample collection throughout the trial.

Group II: Arm B (placebo, THC, nicotine) Experimental Treatment 5 Interventions

Participants complete 3 vaping sessions separated by 7-14 days on study: * VISIT 1: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. * VISIT 2: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. * VISIT 3: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. All participants also undergo blood sample collection throughout the trial.

Group III: Arm A (placebo, THC, nicotine) Experimental Treatment 5 Interventions

Participants complete 3 vaping sessions separated by 7-14 days on study: * VISIT 1: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. * VISIT 2: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. * VISIT 3: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. All participants also undergo blood sample collection throughout the trial.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study involving six volunteers, both liquid and capsule forms of THC-containing hemp oils produced plasma THC levels comparable to synthetic THC (dronabinol) used for appetite stimulation, indicating their potential efficacy as dietary supplements.

The study found that THC and its metabolites were detectable in plasma for varying durations, with THCCOOH persisting for up to 39.5 hours after dosing, suggesting a prolonged effect of THC from hemp oils compared to synthetic forms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delta(9)-tetrahydrocannabinol, 11-hydroxy-delta(9)-tetrahydrocannabinol and 11-nor-9-carboxy-delta(9)-tetrahydrocannabinol in human plasma after controlled oral administration of cannabinoids. Goodwin, RS., Gustafson, RA., Barnes, A., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06334016

Evaluating the Delivery and Effects of THC Vaping Liquids ... This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8975973/

Are vaporizers a lower-risk alternative to smoking cannabis? A small non-randomized trial (n = 12) reported significantly improved respiratory symptoms and forced vital capacity (FVC) among cannabis smokers who switched ...

3. ajpmonline.org ajpmonline.org/article/S0749-3797(25)00147-3/fulltext

Adolescent Cannabis Vaping Trends (2021–2023): Delta-9 ... This study reveals that vaping of delta-9-tetrahydrocannabinol, cannabidiol, and synthetic cannabinoids has increased among US adolescents from 2021 to 2023.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0749379725001473

Adolescent Cannabis Vaping Trends (2021–2023): Delta-9 ... This study reveals that vaping of delta-9-tetrahydrocannabinol, cannabidiol, and synthetic cannabinoids has increased among US adolescents from 2021 to 2023.

5. stacks.cdc.gov stacks.cdc.gov/view/cdc/113488/cdc_113488_DS1.pdf

containing e-cigarette, or vaping, product use behaviors ... Results: Among 3,980 THC-EVP users, 23.5% used THC-EVPs daily. Common brands of THC-EVPs used were Dank Vapes (47.7%) and Golden Gorilla (38.7% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7757764/

Cannabis vaping: Understanding the health risks of a ... Studies suggest that vaporized cannabis may generate fewer chemicals than smoked cannabis and could thus represent a less harmful, or 'healthier ...

7. npr.org npr.org/2025/02/03/nx-s1-5246302/vape-marijuana-weed-pesticides-chemicals

Vaping weed is very popular, but users should be aware it ... Whereas the average cannabis flower contains about 17% or 18% THC, the concentration in vapes can reach 95% or higher.

8. fda.gov fda.gov/safety/medical-product-safety-information/tetrahydrocannabinol-thc-containing-vaping-products-vaping-illnesses

Tetrahydrocannabinol (THC)-containing Vaping Products Consumers are likely aware of the recent reports of respiratory illnesses – including some resulting in deaths – following the use of vaping products.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8251682/

Toxicology of flavoring- and cannabis-containing e-liquids ... At least 65 individual flavoring ingredients in e-liquids or aerosols from e-cigarettes induced toxicity in the respiratory tract, cardiovascular and ...

10. dea.gov dea.gov/sites/default/files/2020-06/Vaping%20and%20Marijuana%20Concentrates-2020.pdf

Drug Fact Sheet: Vaping and Marijuana Concentrates One method is the butane extraction process. This process is particularly dangerous because it uses highly flammable butane to extract the THC from the cannabis.