Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA057201-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Gummy | Placebo Comparator | Participants will self-administer a gummy containing 0mg THC |
|
| Low Dose Gummy | Experimental | Participants will self-administer a gummy containing 10mg THC |
|
| High Dose Gummy | Experimental | Participants will self-administer a gummy containing 25mg THC |
|
| Placebo Chocolate | Placebo Comparator | Participants will self-administer chocolate containing 0mg THC |
|
| Low Dose Chocolate | Experimental | Participants will self-administer chocolate containing 10mg THC |
|
| High Dose Chocolate | Experimental | Participants will self-administer chocolate containing 25mg THC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis | Drug | Cannabis will be orally ingested |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| CMax for THC metabolite- THCCOOH |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tory Spindle, PhD | Contact | 410-550-0529 | tspindle@jhmi.edu | |
| Lindsay Howard | Contact | 410-550-0009 | lhowar29@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tory Spindle, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Behavioral Pharmacology Research Unit | Recruiting | Baltimore | Maryland | 21224 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C587251 | nabiximols |
Not provided
Not provided
Not provided
All participants will complete all dose conditions in a randomized order.
Not provided
Not provided
Double-blind, placebo controlled
|
| Placebo Beverage | Placebo Comparator | Participants will self-administer a beverage containing 0mg THC |
|
| Low Dose Beverage | Experimental | Participants will self-administer a beverage containing 10mg THC |
|
| High Dose Beverage | Experimental | Participants will self-administer a beverage containing 25mg THC |
|
|
| Placebo | Drug | Placebo will be orally ingested |
|
| 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 |
| "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 |
| "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 |
| 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 |
| 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 |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| "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 |
| "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 |