# Assessing pharmacokinetic and pharmacodynamic variability of Δ9-tetrahydrocannabinol delivered from vaping products with and without concurrent use of nicotine

> **NIH NIH R01** · ROSWELL PARK CANCER INSTITUTE CORP · 2024 · $666,413

## Abstract

PROJECT SUMMARY
There is a growing trend in the use of vaping devices used to administer liquid concentrates containing Δ9-
tetrahydrocannabinol (THC). However, there is a gap in our knowledge and understanding of the
pharmacokinetics (PK) and pharmacodynamics (PD) of THC delivered from this new generation of cannabis
products. The literature on nicotine vaping has clearly shown that vaping product characteristics and user
behaviors influence the PK/PD of vaped substances. Additionally, most cannabis consumers who vape liquid
cannabis concentrates also report concurrent use of nicotine-containing vaping products (e-cigarettes). Building
on strategies used to establish the evidence base on the PK/PD of nicotine-containing vaping products, this
project will examine the PK/PD profile of THC-containing liquid concentrates delivered through vaping
devices WITH and WITHOUT co-use of nicotine through completion of three specific aims: Aim 1 is to examine
how vaping product characteristics and user behaviors impact the PK/PD of THC. Aim 1 will characterize the
PK/PD variability in real-world settings. This will be achieved by using a mobile laboratory bus to recruit current
vapers of THC-containing liquids and examine their PK/PD. Study participants will use their own commercially
obtained THC cartridges ad lib through their usual vaping device. In Aim 2, a controlled laboratory paradigm will
be used to compare the PK/PD profiles of equivalent standard THC units delivered from vaping liquids vs smoked
cannabis. Aim 3 will assess the PK/PD profiles of THC vaping liquids sequentially administered with nicotine
using a double-blind, placebo-controlled, randomized within-subjects trial design. This highly innovative
approach will offer a significant advantage over the existing literature by combining naturalistic observational
methods and controlled laboratory assessments to provide a depiction of the PK/PD of THC delivered through
vaping liquids. The findings will be directly relevant for the existing cannabis market and consumers who use
these products. This project will improve our understanding of the PK/PD effects of THC by characterizing the
PK/PD profiles of THC vaping liquid formulations and devices used by cannabis consumers, establishing
differences in the effects of these products relative to smoked cannabis, and providing necessary data on how
co-use of vaped nicotine and THC may impact THC PK/PD. Data from this project will be highly relevant for
informing future regulatory and consumer safety efforts for THC vaping products.

## Key facts

- **NIH application ID:** 10868568
- **Project number:** 5R01DA057228-03
- **Recipient organization:** ROSWELL PARK CANCER INSTITUTE CORP
- **Principal Investigator:** Maciej Lukasz Goniewicz
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $666,413
- **Award type:** 5
- **Project period:** 2022-09-30 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10868568

## Citation

> US National Institutes of Health, RePORTER application 10868568, Assessing pharmacokinetic and pharmacodynamic variability of Δ9-tetrahydrocannabinol delivered from vaping products with and without concurrent use of nicotine (5R01DA057228-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10868568. Licensed CC0.

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