Health TrialsbyHealthPanel

The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles

ConditionCannabis Use
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-55
SponsorJohns Hopkins University

About this trial

This study will examine the pharmacokinetics and pharmacodynamics of delta-9-tetrahydrocannabinol (THC)-infused chocolates, gummies, and drinks. Healthy adults (N=40) will complete 9 drug administration sessions, including an overnight stay prior to each session. Participants will consume THC containing products in a fasted state; following drug administration, the participants will complete cognitive and psychomotor tasks, subjective assessments, have blood collected, and vital signs monitored.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Have provided written informed consent.

Be between the ages of 21 and 55.

Be in good general health based on screening procedures (e.g., physical exam, medical history interview, vital signs, routine blood tests).

Test negative for illicit drugs (including cannabis) and test negative for alcohol (0% BAC) at screening and before any study sessions.

Disqualifiers

Self-reported use of illicit drugs (e.g., amphetamine, cannabis, cocaine, methamphetamine, MDMA, LSD, ketamine, heroin, psilocybin, prescription medications not prescribed to the person) in the past 30 days.

History of significant allergic reaction or significant hypersensitivity to cannabis or to any of the other ingredients in the study products.

Current concomitant medication use that may interact with the study drug including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow therapeutic index such as warfarin, cyclosporine, and amphotericin B.

History of or current evidence of a significant medical condition that, in the opinion of the investigator or medical staff, will impact the participant's safety or interfere with study outcomes.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Cannabis

    Drug

    Cannabis will be orally ingested

  • Placebo

    Drug

    Placebo will be orally ingested

Treatment groups

80 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Placebo GummyPlacebo comparator 1 intervention
Group B: Low Dose GummyExperimental treatment 1 intervention
Group C: High Dose GummyExperimental treatment 1 intervention
Group D: Placebo ChocolatePlacebo comparator 1 intervention
Group E: Low Dose ChocolateExperimental treatment 1 intervention
Group F: High Dose ChocolateExperimental treatment 1 intervention
Group G: Placebo BeveragePlacebo comparator 1 intervention
Group H: Low Dose BeverageExperimental treatment 1 intervention
Group I: High Dose BeverageExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT)

Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Total correct trials out of 90 recorded is primary outcome (lower scores indicate worse performance).

Time frame
8 hours
2

Psychomotor performance as assessed by the Correct Trials on the Digit Symbol Substitution Task(DSST)

Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Total correct trials in 90 seconds is primary outcome (lower scores indicate worse performance).

Time frame
8 hours
3

Attention as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT)

Computerized version of the Divided Attention Task will be administered to assess attention. Mean distance (in computer pixels) of the mouse cursor from the center target stimulus is primary outcome (lower scores indicate worse performance).

Time frame
8 hours
4

Executive functioning as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT)

Computerized version of the Divided Attention Task will be administered to assess executive functioning. Mean distance (in computer pixels) of the mouse cursor from the center target stimulus is primary outcome (lower scores indicate worse performance).

Time frame
8 hours

Secondary outcomes

1

CMax for THC metabolite - 11-OH-THC

Blood concentrations of 11-OH-THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.

Time frame
8 hours
2

CMax for THC metabolite- THCCOOH

Blood concentrations of THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.

Time frame
8 hours
3

AUC for THC metabolite - 11-OH-THC

Blood concentrations of 11-OH-THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.

Time frame
8 hours
4

AUC for THC metabolite - THCCOOH

Blood concentrations of THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.

Time frame
8 hours

Other outcomes

Sponsors and contacts

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

Johns Hopkins University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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