Recruiting
Phase 1

Cannabis Edibles

Sponsor:

Johns Hopkins University

Code:

NCT05602649

Conditions

Cannabis Use

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Interventions

Cannabis

Placebo

Study Details

Brief summary:

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.

Conditions

Cannabis Use

Study ID

NCT05602649

Start date

Jul 10, 2024

Status verified date

Apr, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Inclusion Criteria

  • 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.
  • Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at admission for each session.
  • Have prior experience using THC-dominant cannabis.
  • Have a body mass index (BMI) in the range of 16 to 38 kg/m2.
  • Have not donated blood in the past 30 days.

Exclusion Criteria

  • 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.
  • Evidence of current psychiatric condition (based on MINI for DSM-5).
  • Been in treatment previously for cannabis use disorder.
  • Receiving of any drug as part of a research study within the past 30 days.
  • History of epilepsy or other serious medical condition.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

Cannabis

Cannabis will be orally ingested

Placebo

Placebo will be orally ingested

Primary outcome measure

  • Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT) [ Time Frame: 8 hours ]
  • Psychomotor performance as assessed by the Correct Trials on the Digit Symbol Substitution Task(DSST) [ Time Frame: 8 hours ]
  • Attention as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT) [ Time Frame: 8 hours ]
  • Executive functioning as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT) [ Time Frame: 8 hours ]
  • DRiving Under the Influence of Drugs (DRUID) application global impairment score - Acute cognitive impairment [ Time Frame: 8 hours ]
  • DRUID application global impairment score - Acute behavioral impairment [ Time Frame: 8 hours ]
  • "Like Drug Effect" as assessed by the Drug Effect Questionnaire (DEQ) [ Time Frame: 8 hours ]
  • "Want to take again" as assessed by the Drug Effect Questionnaire [ Time Frame: 8 hours ]
  • CMax for THC [ Time Frame: 8 hours ]
  • AUC for THC [ Time Frame: 8 hours ]

Central Contacts and Locations

Central contacts

Tory Spindle, PhD

410-550-0529tspindle@jhmi.edu

Lindsay Howard

410-550-0009lhowar29@jhmi.edu

Locations

Johns Hopkins Behavioral Pharmacology Research Unit

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Tory Spindle, PhD

410-550-0529tspindle@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-04-13.