Active, Not Recruiting

NCT Number: NCT02710097

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

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cannabis Alcohol Effect Chemically-Induced Disorders Driving Under the Influence of Alcohol and Other Drugs Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biological Studies Unit, VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Inhaled Cannabis

Drug

~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.

Placebo

Drug

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 Ethanol

Drug

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.

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)

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

A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication
Visual Analog Scale (VAS)

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

Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states.
Cognitive Test Battery

Time frame: +40 mins after start of alcohol administration

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.
Willingness to Drive Scale

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

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.
Number of Joints Scale

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

Subjects will be asked to rate the number of standard joints that they believe they have been administered.
Number of Drinks Scale

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

Subjects will be asked to rate the number of standard drinks that they believe they have been administered.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: THC-ETOH-II

Important dates

Study start: 2016
Primary completion: 2026
Study completion: 2026
First posted: Mar 16, 2016
Registry last updated: Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting