Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I

Study Overview
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Brief Summary
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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.

Detailed Description
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To study the effects of oral ethanol (a target BAC of  0.04 g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized THC (4 mg of THC dissolved in an ethanolic solution; equivalent to smoking approximately 1/4 of a marijuana cigarette, or joint) on driving.

Official Title
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Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I

Conditions
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Cannabis, Alcohol Effect, Driving Under the Influence of Alcohol and Other Drugs

Intervention / Treatment
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* Drug: Active inhaled delta-9-THC
* Drug: Placebo
* Drug: Placebo
* Drug: Active Oral Ethanol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females 21 to 55 years of age (extremes included). Occasional current cannabis users. Experience with drinking 2 or more standard drinks of alcohol at least once in lifetime. Able to provide informed consent. Exclusion Criteria: Cannabis naïve. Alcohol naïve. Positive pregnancy screen Hearing deficits.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active THC and Placebo Ethanol<br> | Drug: Active inhaled delta-9-THC<br>* Low dose THC ( 4 mg), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or joint. Administered over 20 minutes via a vaporizer.<br>Drug: Placebo<br>* Control: Approximately 4 drinks of orange juice or ginger ale covered by a trace amount of ethanol on the surface, each administered over approximately 10 minutes.<br>|
| Experimental: Active THC and Active Ethanol<br> | Drug: Active inhaled delta-9-THC<br>* Low dose THC ( 4 mg), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or joint. Administered over 20 minutes via a vaporizer.<br>Drug: Active Oral Ethanol<br>* 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 consuming approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.<br>|
| Experimental: Placebo THC and Active Ethanol<br> | Drug: Placebo<br>* Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.<br>Drug: Active Oral Ethanol<br>* 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 consuming approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.<br>|
| Placebo Comparator: Placebo THC and Placebo Ethanol<br> | Drug: Placebo<br>* Control: Approximately 4 drinks of orange juice or ginger ale covered by a trace amount of ethanol on the surface, each administered over approximately 10 minutes.<br>Drug: Placebo<br>* Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Road Tracking Error |  | baseline, +20, +50, +120, +180 mins after start of alcohol administration | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 
| 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 | 
| 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 | 
| 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 |