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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05602649
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cannabis Use

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Cannabis — DRUG
    Cannabis will be orally ingested
  • Placebo — DRUG
    Placebo will be orally ingested

Study Details

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.

Key Dates

Start date
Jul 10, 2024
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Placebo Gummy
    Participants will self-administer a gummy containing 0mg THC
  • Experimental: Low Dose Gummy
    Participants will self-administer a gummy containing 10mg THC
  • Experimental: High Dose Gummy
    Participants will self-administer a gummy containing 25mg THC
  • Placebo Comparator: Placebo Chocolate
    Participants will self-administer chocolate containing 0mg THC
  • Experimental: Low Dose Chocolate
    Participants will self-administer chocolate containing 10mg THC
  • Experimental: High Dose Chocolate
    Participants will self-administer chocolate containing 25mg THC
  • Placebo Comparator: Placebo Beverage
    Participants will self-administer a beverage containing 0mg THC
  • Experimental: Low Dose Beverage
    Participants will self-administer a beverage containing 10mg THC
  • Experimental: High Dose Beverage
    Participants will self-administer a beverage containing 25mg THC

Primary Outcome Measure

Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT) [ Time Frame: 8 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Behavioral Pharmacology Research UnitBaltimoreMaryland21224
Tory Spindle, PhD
[email protected]
410-550-0529

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