The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
- Registration Number
- NCT05602649
- Lead Sponsor
- Johns Hopkins University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Low Dose Chocolate Cannabis Participants will self-administer chocolate containing 10mg THC High Dose Chocolate Cannabis Participants will self-administer chocolate containing 25mg THC Placebo Beverage Placebo Participants will self-administer a beverage containing 0mg THC Placebo Gummy Placebo Participants will self-administer a gummy containing 0mg THC Low Dose Beverage Cannabis Participants will self-administer a beverage containing 10mg THC Low Dose Gummy Cannabis Participants will self-administer a gummy containing 10mg THC High Dose Gummy Cannabis Participants will self-administer a gummy containing 25mg THC Placebo Chocolate Placebo Participants will self-administer chocolate containing 0mg THC High Dose Beverage Cannabis Participants will self-administer a beverage containing 25mg THC
- Primary Outcome Measures
Name Time Method Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT) 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).
DRiving Under the Influence of Drugs (DRUID) application global impairment score - Acute cognitive impairment 8 hours Acute cognitive impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
Attention as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT) 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) 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).
DRUID application global impairment score - Acute behavioral impairment 8 hours Acute behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
"Want to take again" as assessed by the Drug Effect Questionnaire 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.
AUC for THC 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.
Psychomotor performance as assessed by the Correct Trials on the Digit Symbol Substitution Task(DSST) 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).
CMax for THC 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.
"Like Drug Effect" as assessed by the Drug Effect Questionnaire (DEQ) 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.
- Secondary Outcome Measures
Name Time Method Tmax for THC metabolite - 11-OH-THC 8 hours 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.
Cmax for CBN 8 hours 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.
Tmax for THC metabolite - THCCOOH 8 hours 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.
CMax for THC metabolite - 11-OH-THC 8 hours 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.
AUC for THC metabolite - 11-OH-THC 8 hours 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.
Cmax for CBG 8 hours 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.
AUC for CBD 8 hours 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.
CMax for THC metabolite- THCCOOH 8 hours 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.
AUC for THC metabolite - THCCOOH 8 hours 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.
Tmax for THC 8 hours 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.
Cmax for CBD 8 hours 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.
AUC for CBN 8 hours 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.
Tmax for CBD 8 hours 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.
Tmax for CBG 8 hours 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.
Attention as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT) 8 hours Computerized version of the Divided Attention Task will be administered to assess attention. The secondary outcome is the number of peripheral stimuli correctly identified.
"Unpleasant Drug Effect" as assessed by the Drug Effect Questionnaire 8 hours 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.
Tmax for CBN 8 hours 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.
Working memory performance as assessed by Reaction Time on Paced Auditory Serial Addition Task (PASAT) 8 hours 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.
"Feel Drug Effect" as assessed by the Drug Effect Questionnaire- 8 hours 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.
AUC for CBG 8 hours 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.
Psychomotor performance as assessed by attempted Trials on the Digit Symbol Substitution Task(DSST) 8 hours Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Number of attempted trials is a secondary outcome.
Executive functioning as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT) 8 hours 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.
Trial Locations
- Locations (1)
Johns Hopkins Behavioral Pharmacology Research Unit
🇺🇸Baltimore, Maryland, United States