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Active, Not Recruiting

NCT Number: NCT02404688

Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition

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 ethanol clamped at BAC 0.04% and THC (1.05 mg in a 70 kg individual) 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).
  • 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.

Treatment and study plan

Active Delta-9-THC

Drug

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.

Placebo

Drug

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

Active Ethanol

Drug

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.

Primary outcomes

  1. Road Tracking Error

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

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

Secondary outcomes

  1. Biphasic Alcohol Effects Scale (BAES)

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

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

  2. Visual Analog Scale (VAS)

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

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

  3. Cognitive Test Battery

    Time frame: +40 mins after start of alcohol and THC infusion

    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.

  4. Willingness to Drive Scale

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

    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.

  5. Number of Joints Scale

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

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

  6. Number of Drinks Scale

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

    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

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2015
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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