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| ID | Type | Description | Link |
|---|---|---|---|
| A523000 | Other Identifier | UW Madison | |
| Protocol Version 2/5/2025 | Other Identifier | UW Madison |
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This study is being done to assess the feasibility of administrating Δ9-THC and Δ8-THC isolates and simultaneously adopting several data harmonization measures to generate uniquely translatable data. This project aims to (1) evaluate the feasibility and acceptability of administering ∆9-THC and Δ8-THC isolates using standardized cannabis dosing units to quantify ∆9-THC and Δ8-THC pharmacokinetics; and (2) evaluate the feasibility and acceptability of adopting standardized impairment detection methods and driving performance definitions and measures on quantifying ∆9-THC and Δ8-THC driving impairment compared to a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| delta-9-THC | Experimental |
| |
| delta-8-THC | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delta-9-THC | Drug | Healthy volunteers will attend three test sessions, at least 14 days apart, in which cognition and driving performance will be assessed following vaporization of (1) Δ9-THC, (2) Δ8-THC, or (3) a placebo. The order of these conditions will be counterbalanced across participants. Serial blood samples will be drawn during each dosing visit and compared with concurrent dried blood spots from a finger stick. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantify analyte concentrations | Quantify delta-9-THC, delta-8-THC, and their primary metabolites in whole blood, plasma, oral fluid, and dried blood spots at several time points before and after acute study drug administration. | 9 months |
| Quantify impairing effects of cannabinoids | Quantify the impairing effects of delta-9-THC and delta-8-THC by measuring the standard deviation of lateral position within the driving simulation and by completing a drug recognition expert field sobriety test for signs of impairment. | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Barkholtz, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D011596 | Psychomotor Disorders |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| C035731 | delta-8-tetrahydrocannabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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|
| Delta-8-THC | Drug | Healthy volunteers will attend three test sessions, at least 14 days apart, in which cognition and driving performance will be assessed following vaporization of (1) Δ9-THC, (2) Δ8-THC, or (3) a placebo. The order of these conditions will be counterbalanced across participants. Serial blood samples will be drawn during each dosing visit and compared with concurrent dried blood spots from a finger stick. |
|
| Placebo | Drug | Healthy volunteers will attend three test sessions, at least 14 days apart, in which cognition and driving performance will be assessed following vaporization of (1) Δ9-THC, (2) Δ8-THC, or (3) a placebo. The order of these conditions will be counterbalanced across participants. Serial blood samples will be drawn during each dosing visit and compared with concurrent dried blood spots from a finger stick. |
|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |