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

NCT02709954 | Active Not Recruiting Phase 1

• 1 other identifier: 1501015208.A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cannabis; Alcohol Effect; Driving Under the Influence of Alcohol and Other Drugs

Outcome Measures

Primary Outcomes (1)

• Road Tracking Error

  baseline, +20, +50, +120, +180 mins after start of alcohol administration

Secondary Outcomes (6)

• Biphasic Alcohol Effects Scale (BAES)

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

• Visual Analog Scale (VAS)

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

• Willingness to Drive Scale

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

• Cognitive Test Battery

  +40 mins after start of alcohol administration

• Number of Joints Scale

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

Study Arms (4)

Active THC and Placebo Ethanol

EXPERIMENTAL

Drug: Active inhaled delta-9-THC; Drug: Placebo

Active THC and Active Ethanol

EXPERIMENTAL

Drug: Active inhaled delta-9-THC; Drug: Active Oral Ethanol

Placebo THC and Active Ethanol

EXPERIMENTAL

Drug: Placebo; Drug: Active Oral Ethanol

Placebo THC and Placebo Ethanol

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Active inhaled delta-9-THC DRUG

Low dose THC (\~4 mg), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes via a vaporizer.

Active THC and Active Ethanol; Active THC and Placebo Ethanol

Placebo DRUG

Control: Approximately 4 drinks of orange juice or ginger ale covered by a trace amount of ethanol on the surface, each administered over approximately 10 minutes.

Active THC and Placebo Ethanol; Placebo THC and Placebo Ethanol

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 consuming approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.

Active THC and Active Ethanol; Placebo THC and Active Ethanol

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Cannabis naïve.
• Alcohol naïve.
• Positive pregnancy screen
• Hearing deficits.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Biological Studies Unit, VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 16, 2016
• Study Start: March 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)