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

Phase 1Active Not RecruitingNCT02710331

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

10 mg capsule of Dronabinol will be administered orally.

PlaceboDRUG

Control: no alcohol, administered for \~80 minutes.

PlaceboDRUG

Control: Placebo pill (no active cannabinoids) administered orally.

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 naïve * Alcohol naïve * Positive pregnancy screen * Hearing deficits * Sesame oil allergy

Locations (1)

Biological Studies Unit, VA Connecticut Healthcare System

West Haven, Connecticut, United States

Outcomes

Primary Outcomes

Change from Baseline: Road Tracking Error

Time frame: baseline, +100, +210 mins after start of dronabinol administration

Secondary Outcomes

Change from Baseline: Biphasic Alcohol Effects Scale (BAES)

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.