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

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of THC Vaping Liquids as a treatment for cannabis use?

Research suggests that 'therapeutic cannavaping,' which involves vaping liquids enriched with cannabinoids like THC, could be an effective way to administer therapeutic cannabinoids. This method may require less concentrated liquid refills, making it a potentially efficient alternative to other forms of cannabis administration. ^{1 2 3 4 5}

Is vaping THC liquids safe for humans?

There is uncertainty about the safety of THC in vaping liquids, as the health consequences are largely unknown due to a lack of comprehensive studies. Additionally, there are concerns about harmful substances like ketene gas forming when certain THC products are heated, which could be harmful to the lungs. ^{1 2 6 7 8}

How is THC Vaping Liquids treatment different from other cannabis use treatments?

THC Vaping Liquids are unique because they involve inhaling vaporized THC, which can include various isomers (different forms of THC) not typically found in natural cannabis. This method of administration is different from traditional smoking or oral consumption, and the presence of these isomers may affect the experience and potential risks associated with use. ^{2 3 9 10 11}

What is the purpose of this trial?

This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety.

Research Team

Danielle M Smith

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Drug vaping applied to cannabis: Is "Cannavaping" a therapeutic alternative to marijuana? [2018]

2. England pubmed.ncbi.nlm.nih.gov

Tetrahydrocannabinol (THC)-containing e-cigarette, or vaping, product use behaviors among adults after the onset of the 2019 outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Absence of Relevant Thermal Conversion of Cannabidiol to Tetrahydrocannabinol in E-Cigarette Vapor and Low-Tetrahydrocannabinol Cannabis Smoke. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and tolerability of oral cannabis preparations in patients with medication overuse headache (MOH)-a pilot study. [2019]

5. United States 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. [2022]

6. Singapore pubmed.ncbi.nlm.nih.gov

Using the BMD Approach to Derive Acceptable Daily Intakes of Cannabidiol (CBD) and Tetrahydrocannabinol (THC) Relevant to Electronic Cigarette Liquids. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Reviewing the Risk of Ketene Formation in Dabbing and Vaping Tetrahydrocannabinol-O-Acetate. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

E-Cigarettes: A Review of New Trends in Cannabis Use. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

EVALI Vaping Liquids Part 1: GC-MS Cannabinoids Profiles and Identification of Unnatural THC Isomers. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Use of flavored cannabis vaping products in the US, Canada, Australia, and New Zealand: findings from the international cannabis policy study wave 4 (2021). [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Simultaneous Temperature Measurements and Aerosol Collection During Vaping for the Analysis of &#916;9-Tetrahydrocannabinol and Vitamin E Acetate Mixtures in Ceramic Coil Style Cartridges. [2021]