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

Phase 1Active Not RecruitingNCT02710097

Yale University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

Active inhaled cannabisDRUG

\~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.

PlaceboDRUG

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.

Active Oral EthanolDRUG

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Biological Studies Unit, VA Connecticut Healthcare System

West Haven, Connecticut, United States

Outcomes

Primary Outcomes

Road Tracking Error

Time frame: baseline, +20, +50, +120, +180 mins after start of alcohol administration

Secondary Outcomes

Biphasic Alcohol Effects Scale (BAES)

A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication

Time frame: 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.

Time frame: 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.

Time frame: +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.

Time frame: 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.

Time frame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration

Number of Drinks Scale

Data from ClinicalTrials.gov

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