Cannabis
Cannabis will be orally ingested
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-04-13
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Cannabis will be orally ingested
marijuanaPlacebo will be orally ingested
Eligibility
primary outcomes
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).
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).
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).
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).
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).
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).
secondary outcomes
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Publications
No exact PMID-linked public article is currently readable locally.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 hours
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Number of attempted trials is a secondary outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.