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The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of inhaled cannabis with varying amounts of 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 cannabis use. Other pharmacodynamic effects of inhaled cannabis with CBD and THC 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 | Smoked placebo cannabis |
|
| 20 mg CBD | Experimental | Smoked cannabis with CBD |
|
| 20 mg CBD + 20 mg THC | Experimental | Smoked cannabis with CBD and THC |
|
| 20 mg THC | Experimental | Smoked cannabis with THC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Cannabis | Drug | Smoked placebo cannabis |
| |
| 20 mg CBD Cannabis |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective drug effect ratings of impairment and abuse liability | Peak subjective ratings of drug effects associated with abuse liability and impairment as measured using visual analogue scales (VAS; 1-100mm). | 6 hours |
| Pharmacokinetics of THC, CBD and metabolites | Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH after exposure (Tmax) | 6 hours |
| Behavioral task performance as assessed by the DRUID App Score | Trough composite scores on the DRUID App | 6 hour |
| THC concentrations in oral fluid | Peak levels of THC in oral fluid after exposure | 6 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ziva Cooper, PhD | 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 |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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 |
Smoked cannabis with CBD |
|
| 20 mg CBD + 20 mg THC Cannabis | Drug | Smoked cannabis with CBD and THC |
|
| 20 mg THC Cannabis | Drug | Smoked cannabis with THC |
|