Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition

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 ethanol clamped at BAC 0.04% and THC (1.05 mg in a 70 kg individual) on driving.

Official Title
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Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition

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 delta-9-THC
* Drug: Placebo
* Drug: Active Ethanol
* Drug: Placebo


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). Exposed to cannabis at least once. Exposed to alcohol at least once. Able to provide informed consent. Exclusion Criteria: Cannabis naive. Alcohol naive. 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 delta-9-THC<br>* Low dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or joint. Administered over 20 minutes.<br>Drug: Placebo<br>* Control: no alcohol, administered for a total of 80 minutes.<br>|
| Experimental: Active THC and Active Ethanol<br> | Drug: Active delta-9-THC<br>* Low dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or joint. Administered over 20 minutes.<br>Drug: Active Ethanol<br>* 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.<br>|
| Experimental: Placebo THC and Active Ethanol<br> | Drug: Placebo<br>* Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes.<br>Drug: Active Ethanol<br>* 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.<br>|
| Placebo Comparator: Placebo THC and Placebo Ethanol<br> | Drug: Placebo<br>* Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes.<br>Drug: Placebo<br>* Control: no alcohol, administered for a total of 80 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Road Tracking Error | changes in road tracking errors between timepoints to assess the effects of alcohol and THC on road tracking errors. | baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion | 

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 and THC infusion | 
| 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 mins after start of alcohol and THC infusion | 
| 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 and THC infusion | 
| 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 mins after start of alcohol and THC infusion | 
| 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 mins after start of alcohol and THC infusion | 
| 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 mins after start of alcohol and THC infusion |