Clinical trial NCT05602649: The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
Official title: The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cannabis Use
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-11-02
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will complete all dose conditions in a randomized order.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: The purpose of this study is to examine the pharmacokinetics (PK) and pharmacodynamics (PD) of 3 popular types of cannabis edibles: THC-infused chocolates, gummies, and drinks. This study will utilize a rigorous double-blind, placebo-controlled, within-subjects design. Healthy adults (N=40; 20 males, 20 females) will complete 9 outpatient drug administration sessions in a randomized order. After 8 hours of monitored fasting, participants will consume 1 of 3 types of edibles (chocolates, gummies, or drinks) that are representative of current retail cannabis products. Products will contain 0 (placebo), 10, or 25mg THC. PD assessments include a battery of cognitive/psychomotor performance tasks shown to be sensitive to oral cannabis at these doses and subjective drug effects. Blood samples will be drawn to measure THC and its primary metabolites. Vital signs will be recorded. These procedures will be completed during each of the 9 study sessions.

Eligibility criteria: 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.

Primary outcomes:
measure: Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT)
timeFrame: 8 hours
measure: Psychomotor performance as assessed by the Correct Trials on the Digit Symbol Substitution Task(DSST)
timeFrame: 8 hours
measure: Attention as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT)
timeFrame: 8 hours
measure: Executive functioning as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT)
timeFrame: 8 hours
measure: DRiving Under the Influence of Drugs (DRUID) application global impairment score - Acute cognitive impairment
timeFrame: 8 hours
measure: DRUID application global impairment score - Acute behavioral impairment
timeFrame: 8 hours
measure: "Like Drug Effect" as assessed by the Drug Effect Questionnaire (DEQ)
timeFrame: 8 hours
measure: "Want to take again" as assessed by the Drug Effect Questionnaire
timeFrame: 8 hours
measure: CMax for THC
timeFrame: 8 hours
measure: AUC for THC
timeFrame: 8 hours
Secondary outcomes:
measure: CMax for THC metabolite - 11-OH-THC
timeFrame: 8 hours
measure: CMax for THC metabolite- THCCOOH
timeFrame: 8 hours
measure: AUC for THC metabolite - 11-OH-THC
timeFrame: 8 hours
measure: AUC for THC metabolite - THCCOOH
timeFrame: 8 hours
measure: Tmax for THC
timeFrame: 8 hours
measure: Tmax for THC metabolite - 11-OH-THC
timeFrame: 8 hours
measure: Tmax for THC metabolite - THCCOOH
timeFrame: 8 hours
measure: Cmax for CBD
timeFrame: 8 hours
measure: Cmax for CBN
timeFrame: 8 hours
measure: Cmax for CBG
timeFrame: 8 hours
measure: AUC for CBD
timeFrame: 8 hours
measure: AUC for CBN
timeFrame: 8 hours
measure: AUC for CBG
timeFrame: 8 hours
measure: Tmax for CBD
timeFrame: 8 hours
measure: Tmax for CBN
timeFrame: 8 hours
measure: Tmax for CBG
timeFrame: 8 hours
measure: Psychomotor performance as assessed by attempted Trials on the Digit Symbol Substitution Task(DSST)
timeFrame: 8 hours
measure: Working memory performance as assessed by Reaction Time on Paced Auditory Serial Addition Task (PASAT)
timeFrame: 8 hours
measure: Attention as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT)
timeFrame: 8 hours
measure: Executive functioning as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT)
timeFrame: 8 hours
measure: "Unpleasant Drug Effect" as assessed by the Drug Effect Questionnaire
timeFrame: 8 hours
measure: "Feel Drug Effect" as assessed by the Drug Effect Questionnaire-
timeFrame: 8 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Tory Spindle, PhD
role: PRINCIPAL_INVESTIGATOR
References: