Marijuana Effects on Simulated Driving Performance

Study Overview
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Brief Summary
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This study will examine the effects of various strains of marijuana on simulated driving performance; the effects of alcohol administration will also be examined to further understand how marijuana-induced driving changes compare to the effects of alcohol. Secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.

Official Title
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Marijuana Effects on Simulated Driving Performance

Conditions
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Cannabis, Cannabis Use, Marijuana, Marijuana Usage, Alcohol Drinking

Intervention / Treatment
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* Drug: Marijuana
* Drug: Alcohol
* Drug: placebo alcohol
* Drug: Inactive marijuana


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, adult participants Ages 21-50 History of marijuana use History of alcohol use Exclusion Criteria: Clinically significant medical conditions Ongoing/significant drug use outside of marijuana and alcohol use

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 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: Sequential Assignment
Interventional Model Description: Within-subject, randomized, placebo-controlled, double-dummy, double-blind study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Marijuana Dose<br>Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions | Drug: Marijuana<br>* Experimental, non-therapeutic administration of active marijuana dose(s)<br>* Other names: Active cannabis;|
| Placebo Comparator: Inactive Marijuana Dose<br>Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions | Drug: Inactive marijuana<br>* Experimental, non-therapeutic administration of inactive marijuana dose(s)<br>* Other names: inactive cannabis;|
| Active Comparator: Active Alcohol Dose<br>Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions | Drug: Alcohol<br>* Experimental, non-therapeutic administration of active alcohol dose(s)<br>* Other names: Active alcohol;|
| Placebo Comparator: Inactive Alcohol Dose<br>Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions | Drug: placebo alcohol<br>* Experimental, non-therapeutic administration of inactive alcohol dose(s)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simulated Driving Performance | We will examine various features of driving acuity (e.g.,break latency, lane departures) | These outcomes will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject- and Observer-Rated Outcomes | Participants will report the subjective effects of the drug dose(s) on standardized measures; trained observers rate participant outcomes on standardized scales | These outcomes (VAS scores) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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simulated driving, outpatient