Clinical trial NCT06055231: PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Official title: A Randomized Within-Subject Cross-Over Study to Compare Short-Term PK/PD Effects of Vaping THC-containing Liquids vs. Smoked Cannabis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: We will conduct a randomized, within-subjects clinical study to compare short-term pharmacokinetic (PK) and pharmacodynamic (PD) effects of Δ9-tetrahydrocannabinol (THC) vaping liquids vs. smoked cannabis containing 6 equivalent standard THC units (5 mg THC=1 Standard THC Unit (STU)) in healthy community members who are current users of both products. While smoking cannabis remains the most common mode of THC use among adults and youth, alternative modes of delivery, such as Electronic Vaping Products (EVPs), are becoming increasingly popular for the delivery of cannabinoids. Declining cannabis risk perceptions, increasing normalization of cannabis, greater legal access and availability to cannabis, ease of administration, and ability to conceal vaped THC use have likely contributed to increasing prevalence of use throughout the population across all age groups. Comparing vaping THC containing liquids with smoking cannabis can serve as an important benchmark for evaluating the delivery and effects of THC vaping products and, their relative safety

Detailed description: PRIMARY OBJECTIVE:

I. Compare the PK/PD profiles of delta-9 tetrahydrocannabinol (THC) from equivalent standard THC doses (30mg) administered as vaped THC liquid vs. smoked cannabis using a within-subject design.

SECONDARY OBJECTIVES:

I. Safety

PRIMARY OBJECTIVE:

I. Compare the PK/PD profiles of delta-9 tetrahydrocannabinol (THC) from equivalent standard THC doses (30mg) administered as vaped THC liquid vs. smoked cannabis using a within-subject design.

SECONDARY OBJECTIVES:

I. Safety

Eligibility criteria: Inclusion Criteria:

* Age \>= 21 years of age
* Report concurrent use of commercial (medical or recreational) smoked cannabis and THC vaping cartridges for at least 3 months prior to enrollment
* Report smoking cannabis and THC- vaping liquid use at the potency level of the study product at least weekly (4x/month)
* 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) and semi -quantitative urinary tetrahydrocannabinol-carboxylic acid (THCA) rapid test (NarcoCheck® THC PreDosage) during baseline testing, prior to receiving any study-related products
* 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:

* • Illegal or non-prescription drug use within the past 90 days. As detected by NacroCheck® Évolutive® (detection in human urine of the 12 most currently abused drugs) at the first session and prior to receiving any study product

  * Report 2 or more drinking occasions/week with 4 or more drinks/occasion
  * Report of daily nicotine use
  * Current or prior diagnosis of any psychotic disorders
  * Current or prior diagnosis of chronic heart conditions
  * Current or prior diagnosis of any respiratory condition
  * Pregnant or currently trying to become pregnant (females)
  * Detection level 4-5 (\>300 ng/mL) from a semi-quantitative urinary THCA rapid test (NarcoCheck® THC PreDosage)
  * Unwilling or unable to follow protocol requirements
  * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for participation

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: From baseline to 360 minutes after consuming product
measure: Area under the plasma concentration time curve from 0-360 minutes ((AUC^0-360)
timeFrame: From baseline to 360 minutes after consuming product
measure: Time to maximum concentration of THC in plasma (Tmax)
timeFrame: From baseline to 360 minutes after consuming product
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 360 minutes after consuming product
measure: Puffing behaviors
timeFrame: Through study completion, an average of 14 days
measure: Short term effects of THC
timeFrame: Through Study completion, an average of 14 days
measure: Cognitive Performance as assessed by the Digit Symbol Substitution Task (DSST)
timeFrame: Through study completion, an average of 14 days
measure: Paced Auditory Serial Addition Task (PASET)
timeFrame: Through study completion , an average of 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Roswell Park Comprehensive Cancer Center
name: Danielle Smith
role: PRINCIPAL_INVESTIGATOR
References: