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

NCT05602649 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB003549261R01DA057201-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• 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).

  8 hours

• 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).

  8 hours

• 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).

  8 hours

• 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).

  8 hours

• DRiving Under the Influence of Drugs (DRUID) application global impairment score - Acute cognitive impairment

  Acute cognitive impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).

  8 hours

• DRUID application global impairment score - Acute behavioral impairment

  Acute behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).

  8 hours

• "Like Drug Effect" as assessed by the Drug Effect Questionnaire (DEQ)

  The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.

  8 hours

• "Want to take again" as assessed by the Drug Effect Questionnaire

  The DEQ will be used to obtain subjective ratings of "want to take drug again". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.

  8 hours

• CMax for THC

  Blood concentrations of 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.

  8 hours

• AUC for THC

  Blood concentrations of 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.

  8 hours

Secondary Outcomes (22)

• CMax for THC metabolite - 11-OH-THC

  8 hours

• CMax for THC metabolite- THCCOOH

  8 hours

• AUC for THC metabolite - 11-OH-THC

  8 hours

• AUC for THC metabolite - THCCOOH

  8 hours

• Tmax for THC

  8 hours

Study Arms (9)

Placebo Gummy

PLACEBO COMPARATOR

Participants will self-administer a gummy containing 0mg THC

Drug: Placebo

Low Dose Gummy

EXPERIMENTAL

Participants will self-administer a gummy containing 10mg THC

Drug: Cannabis

High Dose Gummy

EXPERIMENTAL

Participants will self-administer a gummy containing 25mg THC

Drug: Cannabis

Placebo Chocolate

PLACEBO COMPARATOR

Participants will self-administer chocolate containing 0mg THC

Drug: Placebo

Low Dose Chocolate

EXPERIMENTAL

Participants will self-administer chocolate containing 10mg THC

Drug: Cannabis

High Dose Chocolate

EXPERIMENTAL

Participants will self-administer chocolate containing 25mg THC

Drug: Cannabis

Placebo Beverage

PLACEBO COMPARATOR

Participants will self-administer a beverage containing 0mg THC

Drug: Placebo

Low Dose Beverage

EXPERIMENTAL

Participants will self-administer a beverage containing 10mg THC

Drug: Cannabis

High Dose Beverage

EXPERIMENTAL

Participants will self-administer a beverage containing 25mg THC

Drug: Cannabis

Interventions

Placebo DRUG

Placebo will be orally ingested

Placebo Beverage; Placebo Chocolate; Placebo Gummy

Cannabis DRUG

Cannabis will be orally ingested

Also known as: marijuana

High Dose Beverage; High Dose Chocolate; High Dose Gummy; Low Dose Beverage; Low Dose Chocolate; Low Dose Gummy

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Interventions

nabiximols

Study Officials

• Tory Spindle, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tory Spindle, PhD

CONTACT

410-550-0529; tspindle@jhmi.edu

Lindsay Howard

CONTACT

410-550-0009; lhowar29@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo controlled
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will complete all dose conditions in a randomized order.

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 2, 2022
• Study Start: July 10, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)