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The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.
To study the effects of ethanol clamped at BAC 0.04% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) on driving.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active THC and Placebo Ethanol | Experimental |
| |
| Active THC and Active Ethanol | Experimental |
| |
| Placebo THC and Active Ethanol | Experimental |
| |
| Placebo THC and Placebo Ethanol | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Dronabinol | Drug | 10 mg capsule of Dronabinol will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline: Road Tracking Error | baseline, +100, +210 mins after start of dronabinol administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline: Biphasic Alcohol Effects Scale (BAES) | A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication. | baseline, +60, +90, +210, +360 mins after start of dronabinol administration |
| Change from Baseline: Visual Analog Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biological Studies Unit, VA Connecticut Healthcare System | West Haven | Connecticut | 06516 | United States |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug | Control: no alcohol, administered for ~80 minutes. |
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| Placebo | Drug | Control: Placebo pill (no active cannabinoids) administered orally. |
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| Active Ethanol | Drug | Target BrAC of 0.04% reached over 20 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 2 drinks over 1 hour. Administered over a total of 80 minutes. |
|
Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states. |
| baseline, +60, +90, +210, +360 mins after start of dronabinol administration |
| Change from Baseline: Cognitive Test Battery | Several computer tasks will be administered to assess alcohol and THC effects on driving related cognition, including: visual vigilance, visual motor function, attention and working memory, and processing speed. | baseline, +120 mins after start of dronabinol administration |
| Change from Baseline: Willingness to Drive Scale | Subjects will be asked to rate their willingness to drive at their current state in the context of various scenarios including willingness to drive from testing facility to a number of destinations that are different driving distances. | baseline, +60, +90, +210, +360 mins after start of dronabinol administration |
| Change from Baseline: Number of Joints Scale | Subjects will be asked to rate the number of standard joints that they believe they have been administered. | baseline, +60, +90, +210, +360 mins after start of dronabinol administration |
| Change from Baseline: Number of Drinks Scale | Subjects will be asked to rate the number of standard drinks that they believe they have been administered. | baseline, +60, +90, +210, +360 mins after start of dronabinol administration |