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NCT Number: NCT02710331

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

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

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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% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) 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 naïve
  • Alcohol naïve
  • Positive pregnancy screen
  • Hearing deficits
  • Sesame oil allergy

Treatment and study plan

Active Dronabinol

Drug

10 mg capsule of Dronabinol will be administered orally.

Placebo

Drug

Control: no alcohol, administered for ~80 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. Change from Baseline: Road Tracking Error

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

Secondary outcomes

  1. Change from Baseline: Biphasic Alcohol Effects Scale (BAES)

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

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

  2. Change from Baseline: Visual Analog Scale (VAS)

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

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

  3. Change from Baseline: Cognitive Test Battery

    Time frame: baseline, +120 mins after start of dronabinol 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.

  4. Change from Baseline: Willingness to Drive Scale

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

  5. Change from Baseline: Number of Joints Scale

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

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

  6. Change from Baseline: Number of Drinks Scale

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

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2016
Registry last updated
Apr 27, 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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