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

Cannabis Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05602649
• Other study ID #: IRB00354926
• Secondary ID: 1R01DA057201-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 2024
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Tory Spindle, PhD
• Phone: 410-550-0529
• Email: tspindle[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse

Intervention

Drug:
• Cannabis
Cannabis will be orally ingested
• Placebo
Placebo will be orally ingested

Locations

Country	Name	City	State
United States	Johns Hopkins Behavioral Pharmacology Research Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	"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
Primary	"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
Primary	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
Primary	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	CMax for THC metabolite - 11-OH-THC	Blood concentrations of 11-OH-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
Secondary	CMax for THC metabolite- THCCOOH	Blood concentrations of THCCOOH 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
Secondary	AUC for THC metabolite - 11-OH-THC	Blood concentrations of 11-OH-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	AUC for THC metabolite - THCCOOH	Blood concentrations of THCCOOH 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	Tmax for THC	Blood concentrations of THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.	8 hours
Secondary	Tmax for THC metabolite - 11-OH-THC	Blood concentrations of 11-OH-THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.	8 hours
Secondary	Tmax for THC metabolite - THCCOOH	Blood concentrations of THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.	8 hours
Secondary	Cmax for CBD	Blood concentrations of CBD 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
Secondary	Cmax for CBN	Blood concentrations of CBN 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
Secondary	Cmax for CBG	Blood concentrations of CBG 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
Secondary	AUC for CBD	Blood concentrations of CBD 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	AUC for CBN	Blood concentrations of CBN 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	AUC for CBG	Blood concentrations of CBG 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	Tmax for CBD	Blood concentrations of CBD will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.	8 hours
Secondary	Tmax for CBN	Blood concentrations of CBN will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.	8 hours
Secondary	Tmax for CBG	Blood concentrations of CBG will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.	8 hours
Secondary	Psychomotor performance as assessed by attempted Trials on the Digit Symbol Substitution Task(DSST)	Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Number of attempted trials is a secondary outcome.	8 hours
Secondary	Working memory performance as assessed by Reaction Time on Paced Auditory Serial Addition Task (PASAT)	Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. The secondary outcome is the mean reaction time (in milliseconds) to select correct responses.	8 hours
Secondary	Attention as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT)	Computerized version of the Divided Attention Task will be administered to assess attention. The secondary outcome is the number of peripheral stimuli correctly identified.	8 hours
Secondary	Executive functioning as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT)	Computerized version of the Divided Attention Task will be administered to assess executive functioning. The secondary outcome is the number of peripheral stimuli correctly identified.	8 hours
Secondary	"Unpleasant Drug Effect" as assessed by the Drug Effect Questionnaire	The DEQ will be used to obtain subjective ratings of "unpleasant drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.	8 hours
Secondary	"Feel Drug Effect" as assessed by the Drug Effect Questionnaire-	The DEQ will be used to obtain subjective ratings of "feel drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.	8 hours