Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III

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% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) on driving.

Official Title
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Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III

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 Dronabinol
* Drug: Placebo
* Drug: Placebo
* Drug: Active 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). Exposed to cannabis at least once. Exposed to alcohol at least once. Able to provide informed consent. Exclusion Criteria: Cannabis naïve Alcohol naïve Positive pregnancy screen Hearing deficits Sesame oil allergy

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 Dronabinol<br>* 10 mg capsule of Dronabinol will be administered orally.<br>Drug: Placebo<br>* Control: no alcohol, administered for  80 minutes.<br>|
| Experimental: Active THC and Active Ethanol<br> | Drug: Active Dronabinol<br>* 10 mg capsule of Dronabinol will be administered orally.<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: Placebo pill (no active cannabinoids) administered orally.<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: no alcohol, administered for  80 minutes.<br>Drug: Placebo<br>* Control: Placebo pill (no active cannabinoids) administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline: Road Tracking Error |  | baseline, +100, +210 mins after start of dronabinol administration | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |