Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition

Phase 1Active Not RecruitingNCT02404688

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 ethanol clamped at BAC 0.04% and THC (1.05 mg in a 70 kg individual) 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 delta-9-THCDRUG

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.

PlaceboDRUG

Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes.

Active EthanolDRUG

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.

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). * 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.

Locations (1)

Biological Studies Unit, VA Connecticut Healthcare System

West Haven, Connecticut, United States

Outcomes

Primary Outcomes

Road Tracking Error

changes in road tracking errors between timepoints to assess the effects of alcohol and THC on road tracking errors.

Time frame: baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion

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 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.

Time frame: 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.

Time frame: +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.

Time frame: 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.

Time frame: baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion

Data from ClinicalTrials.gov

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