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NCT Number: NCT06055231

PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis

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

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Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vape device

Behavioral

Consume THC via vape defice

Other names: Behavioral Conditioning therapy, Behavioral Modification

Joint

Behavioral

Consume THC via joint

Other names: Behavior Conditioning Therapy, Behavior Modification

Marijuana via vape device

Drug

Given via vape device

Other names: Cannibis

Marijuana via joint

Drug

Given via joint

Other names: Cannibis

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: From baseline to 360 minutes after consuming product

    Blood samples will be collected for plasma levels of THC. All individual pharmacokinetic (PK) parameters will be derived from plasma THC concentrations-versus-time data by non-compartmental analysis using Phoenix WinNonlin, corrected for baseline THC concentrations. Mean differences for each measure will be compared between the experimental (THC vaping) and active control (smoked cannabis) conditions, and by sex

  2. Area under the plasma concentration time curve from 0-360 minutes ((AUC^0-360)

    Time frame: From baseline to 360 minutes after consuming product

    Blood samples will be collected for plasma levels of THC. All individual pharmacokinetic (PK) parameters will be derived from plasma THC concentrations-versus-time data by non-compartmental analysis using Phoenix WinNonlin, corrected for baseline THC concentrations. Mean differences for each measure will be compared between the experimental (THC vaping) and active control (smoked cannabis) conditions, and by sex.

  3. Time to maximum concentration of THC in plasma (Tmax)

    Time frame: From baseline to 360 minutes after consuming product

    Blood samples will be collected for plasma levels of THC.All individual pharmacokinetic (PK) parameters will be derived from plasma THC concentrations-versus-time data by non-compartmental analysis using Phoenix WinNonlin, corrected for baseline THC concentrations. Mean differences for each measure will be compared between the experimental (THC vaping) and active control (smoked cannabis) conditions, and by sex.

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Up to 360 minutes after consuming product

    Number of subjects who experienced an adverse event during the study .

  2. Puffing behaviors

    Time frame: Through study completion, an average of 14 days

    Measure changes in subject puffing behavior by mean number of puffs and duration

  3. Short term effects of THC

    Time frame: Through Study completion, an average of 14 days

    The Drug Effect Questionnaire (DEQ) rates sixteen component items using a visual analog scale (0-100) to examine drug effects pre- and post-use.

  4. Cognitive Performance as assessed by the Digit Symbol Substitution Task (DSST)

    Time frame: Through study completion, an average of 14 days

    computerized sensitive and valid assessment of cognitive dysfunction that correlates with real-world functional ability to complete daily tasks. The outcome is the total number of correct responses.

  5. Paced Auditory Serial Addition Task (PASET)

    Time frame: Through study completion , an average of 14 days

    a validated measure used to assess attention, concentration, working memory, and information processing.

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Smith

CONTACT

[email protected]

8772757724

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Randomized Within-Subject Cross-Over Study to Compare Short-Term PK/PD Effects of Vaping THC-containing Liquids vs. Smoked Cannabis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 26, 2023
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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