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

Primary Purpose

Cigarette Smoking-Related Carcinoma

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Vape device
Joint
Marijuana via vape device
Marijuana via joint
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cigarette Smoking-Related Carcinoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm 1 (Vape followed by Joint)

    Arm II (Joint followed by Vape)

    Arm Description

    Patients receive a vape device with THC containing liquid and consume the provided amount in up to 10 minutes. 7 to 14 days later patients receive a cannabis joint and smoke the provided joint in up to 10 minutes. Patients also undergo blood sample collection throughout the study.

    Patients receive a cannabis joint and smoke the provided joint in up to 10 minutes. 7 to 14 days later patients receive a vape device with THC containing liquid and consume the provided amount in up to 10 minutes. Patients also undergo blood sample collection throughout the study.

    Outcomes

    Primary Outcome Measures

    Peak Plasma Concentration (Cmax)
    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
    Area under the plasma concentration time curve from 0-360 minutes ((AUC^0-360)
    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.
    Time to maximum concentration of THC in plasma (Tmax)
    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 Outcome Measures

    Incidence of adverse events
    Number of subjects who experienced an adverse event during the study .
    Puffing behaviors
    Measure changes in subject puffing behavior by mean number of puffs and duration
    Short term effects of THC
    The Drug Effect Questionnaire (DEQ) rates sixteen component items using a visual analog scale (0-100) to examine drug effects pre- and post-use.
    Cognitive Performance as assessed by the Digit Symbol Substitution Task (DSST)
    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.
    Paced Auditory Serial Addition Task (PASET)
    a validated measure used to assess attention, concentration, working memory, and information processing.

    Full Information

    First Posted
    September 7, 2023
    Last Updated
    October 23, 2023
    Sponsor
    Roswell Park Cancer Institute
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06055231
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 15, 2023 (Anticipated)
    Primary Completion Date
    March 30, 2025 (Anticipated)
    Study Completion Date
    March 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Roswell Park Cancer Institute
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cigarette Smoking-Related Carcinoma

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1 (Vape followed by Joint)
    Arm Type
    Experimental
    Arm Description
    Patients receive a vape device with THC containing liquid and consume the provided amount in up to 10 minutes. 7 to 14 days later patients receive a cannabis joint and smoke the provided joint in up to 10 minutes. Patients also undergo blood sample collection throughout the study.
    Arm Title
    Arm II (Joint followed by Vape)
    Arm Type
    Experimental
    Arm Description
    Patients receive a cannabis joint and smoke the provided joint in up to 10 minutes. 7 to 14 days later patients receive a vape device with THC containing liquid and consume the provided amount in up to 10 minutes. Patients also undergo blood sample collection throughout the study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Vape device
    Other Intervention Name(s)
    Behavioral Conditioning therapy, Behavioral Modification
    Intervention Description
    Consume THC via vape defice
    Intervention Type
    Behavioral
    Intervention Name(s)
    Joint
    Other Intervention Name(s)
    Behavior Conditioning Therapy, Behavior Modification
    Intervention Description
    Consume THC via joint
    Intervention Type
    Drug
    Intervention Name(s)
    Marijuana via vape device
    Other Intervention Name(s)
    Cannibis
    Intervention Description
    Given via vape device
    Intervention Type
    Drug
    Intervention Name(s)
    Marijuana via joint
    Other Intervention Name(s)
    Cannibis
    Intervention Description
    Given via joint
    Primary Outcome Measure Information:
    Title
    Peak Plasma Concentration (Cmax)
    Description
    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
    Time Frame
    From baseline to 360 minutes after consuming product
    Title
    Area under the plasma concentration time curve from 0-360 minutes ((AUC^0-360)
    Description
    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.
    Time Frame
    From baseline to 360 minutes after consuming product
    Title
    Time to maximum concentration of THC in plasma (Tmax)
    Description
    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.
    Time Frame
    From baseline to 360 minutes after consuming product
    Secondary Outcome Measure Information:
    Title
    Incidence of adverse events
    Description
    Number of subjects who experienced an adverse event during the study .
    Time Frame
    Up to 360 minutes after consuming product
    Title
    Puffing behaviors
    Description
    Measure changes in subject puffing behavior by mean number of puffs and duration
    Time Frame
    Through study completion, an average of 14 days
    Title
    Short term effects of THC
    Description
    The Drug Effect Questionnaire (DEQ) rates sixteen component items using a visual analog scale (0-100) to examine drug effects pre- and post-use.
    Time Frame
    Through Study completion, an average of 14 days
    Title
    Cognitive Performance as assessed by the Digit Symbol Substitution Task (DSST)
    Description
    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.
    Time Frame
    Through study completion, an average of 14 days
    Title
    Paced Auditory Serial Addition Task (PASET)
    Description
    a validated measure used to assess attention, concentration, working memory, and information processing.
    Time Frame
    Through study completion , an average of 14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Danielle Smith
    Phone
    8772757724
    Email
    askroswell@roswellpark.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Danielle Smith
    Organizational Affiliation
    Roswell Park Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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