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

NCT06334016 | Not Yet Recruiting Early Phase 1 FDA Drug

• 3 other identifiers: I-3597023NCI-2024-01556R01DA057228
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis Dependence

Outcome Measures

Primary Outcomes (3)

• Maximum concentration of THC in plasma (Cmax)

  Pharmacokinetics (PK) profiles of THC in plasma will be determined using a visual plot of plasma THC concentrations by time. Parameters will be derived using non-compartmental analysis in Phoenix WinNonlin and adjusted for baseline THC levels. Will be summarized by nicotine status using the appropriate descriptive statistics and graphical summaries.

  Up to 21 days

• Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360)

  Blood samples will be collected for plasma levels of THC. Parameters will be derived using linear mixed models

  Up to 21 days

• Time to maximum concentration of THC in plasma (Tmax)

  Blood samples will be collected for plasma levels of THC. Parameters will be derived using linear mixed models.

  Up to 21 days

Secondary Outcomes (8)

• Incidence of adverse events (AEs)

  Up to 30 days after completion of study intervention

• Puffing behaviors

  Up to 21 days

• Puffing behaviors

  Up to 21 days

• Short-term drug effects

  Up to 21 days

• Marijuana Withdrawal Checklist [MWC)

  Up to 21 days

Study Arms (3)

Arm A (placebo, THC, nicotine)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Cannabis sativa Extract; Drug: Nicotine; Drug: Placebo Administration; Other: Questionnaire Administration

Arm B (placebo, THC, nicotine)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Cannabis sativa Extract; Drug: Nicotine; Drug: Placebo Administration; Other: Questionnaire Administration

Arm C (placebo, THC, nicotine)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Cannabis sativa Extract; Drug: Nicotine; Drug: Placebo Administration; Other: Questionnaire Administration

Interventions

Cannabis sativa Extract DRUG

Vape THC

Also known as: Cannabis sativa, Cannabis sativa Flowering Top, Cannabis sativa Subsp. Flowering Top Extract, Cannabis sativa Top

Arm A (placebo, THC, nicotine); Arm B (placebo, THC, nicotine); Arm C (placebo, THC, nicotine)

Nicotine DRUG

Vape active nicotine

Also known as: (-)-Nicotine, NIC

Arm A (placebo, THC, nicotine); Arm B (placebo, THC, nicotine); Arm C (placebo, THC, nicotine)

Placebo Administration DRUG

Vape placebo nicotine

Arm A (placebo, THC, nicotine); Arm B (placebo, THC, nicotine); Arm C (placebo, THC, nicotine)

Questionnaire Administration OTHER

Ancillary studies

Arm A (placebo, THC, nicotine); Arm B (placebo, THC, nicotine); Arm C (placebo, THC, nicotine)

Biospecimen Collection PROCEDURE

Undergo blood collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm A (placebo, THC, nicotine); Arm B (placebo, THC, nicotine); Arm C (placebo, THC, nicotine)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Specimen Handling; nabiximols; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Danielle M Smith

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participants and clinical personnel will be blinded to the nicotine product sequence (active vs. placebo).
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject crossover study

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 27, 2024
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (1)