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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 oral ethanol (target BAC of ~0.04g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized cannabis (~450 mg cannabis plant material at a THC concentration of ~1.7%; roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active inhaled cannabis | Drug | ~450 mg of active cannabis, which is roughly equivalent to smoking 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes via a vaporizer. |
| Measure | Description | Time Frame |
|---|---|---|
| Road Tracking Error | baseline, +20, +50, +120, +180 mins after start of alcohol administration |
| Measure | Description | Time Frame |
|---|---|---|
| Biphasic Alcohol Effects Scale (BAES) | A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication | baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration |
| 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 | Approximately 4 drinks of orange juice or ginger ale covered with a trace amount of ethanol on the surface, each administered over approximately 10 minutes. |
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| Active Oral Ethanol | Drug | 0.4 g/kg ethanol in orange juice or ginger ale to reach a target BrAC of approximately 0.04%. This dose is equivalent to approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes. |
|
| Placebo | Drug | No active cannabinoids. Administered over 20 minutes via a vaporizer. |
|
Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states.
| baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration |
| 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. | +40 mins after start of alcohol administration |
| 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, +20, +50, +120, +180, +240 mins after start of alcohol administration |
| Number of Joints Scale | Subjects will be asked to rate the number of standard joints that they believe they have been administered. | baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration |
| Number of Drinks Scale | Subjects will be asked to rate the number of standard drinks that they believe they have been administered. | baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration |