NCT05602649 · Johns Hopkins University
The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
What this study is about
This study will examine the how the drug moves through the body and how the drug affects the body 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.
View original scientific description
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.
Interventions
DRUG
Cannabis
Cannabis will be orally ingested
DRUG
Placebo
Placebo will be orally ingested
Primary outcome measures
Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Time frame: 8 hours
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).
Psychomotor performance as assessed by the Correct Trials on the Digit Symbol Substitution Task(DSST)
Time frame: 8 hours
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).
Attention as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT)
Time frame: 8 hours
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).
Executive functioning as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT)
Time frame: 8 hours
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).
DRiving Under the Influence of Drugs (DRUID) application global impairment score - Acute cognitive impairment
Time frame: 8 hours
Acute cognitive impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
DRUID application global impairment score - Acute behavioral impairment
Time frame: 8 hours
Acute behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
"Like Drug Effect" as assessed by the Drug Effect Questionnaire (DEQ)
Time frame: 8 hours
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.
"Want to take again" as assessed by the Drug Effect Questionnaire
Time frame: 8 hours
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.
CMax for THC
Time frame: 8 hours
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.
AUC for THC
Time frame: 8 hours
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Baltimore, Maryland
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations