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The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of oral delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.
This double-blind placebo controlled, within-subject study study will assess testing devices that can measure biochemical markers in oral fluid and neurocognitive-performance markers of recent THC or CBD use. Other pharmacodynamic effects of oral THC or CBD will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Oral placebo; sesame and MCT oil |
|
| 20 mg THC | Experimental | THC suspended in sesame oil |
|
| 20 mg CBD | Experimental | CBD suspended in MCT oil |
|
| 20 mg THC + 20 mg CBD | Experimental | THC and CBD in sesame and MCT oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral placebo |
| |
| THC |
| Measure | Description | Time Frame |
|---|---|---|
| Ratings of subjective drug effects | Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm). | 6 hours |
| Concentration of THC, CBD and metabolites in whole blood | Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH as measured in ng/ml | 6 hours |
| Behavioral task performance as assessed by the DRUID App Score | Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance | 6 hours |
| Concentration of THC in oral fluid | Liquid chromatography-tandem mass spectrometry | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziva Cooper, PhD | Contact | 310-206-9942 | zcooper@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ziva Cooper | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
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| Drug |
Oral THC (20 mg) |
|
| CBD | Drug | Oral CBD (20 mg) |
|
| THC + CBD | Drug | Oral THC (20 mg) + CBD (20 mg) |
|