Health TrialsbyHealthPanel

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

ConditionCigarette Smoking-Related Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorRoswell Park Cancer Institute

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

• 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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Vape device

    Behavioral

    Consume THC via vape defice

  • Joint

    Behavioral

    Consume THC via joint

  • Marijuana via vape device

    Drug

    Given via vape device

  • Marijuana via joint

    Drug

    Given via joint

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Arm 1 (Vape followed by Joint)Experimental treatment 2 interventions
Group B: Arm II (Joint followed by Vape)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From baseline to 360 minutes after consuming product
2

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 frame
From baseline to 360 minutes after consuming product
3

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.

Time frame
From baseline to 360 minutes after consuming product

Secondary outcomes

1

Incidence of adverse events

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

Time frame
Up to 360 minutes after consuming product
2

Puffing behaviors

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

Time frame
Through study completion, an average of 14 days
3

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.

Time frame
Through Study completion, an average of 14 days
4

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.

Time frame
Through study completion, an average of 14 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roswell Park Cancer Institute

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: