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

Cannabis Clinical Trial

— THC-ETOH-I  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02709954
• Other study ID #: 1501015208.A
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 2016
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

To study the effects of oral ethanol (a target BAC of ~0.04 g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized THC (4 mg of THC dissolved in an ethanolic solution; equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") on driving.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Active inhaled delta-9-THC
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.
• Placebo
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.
• Placebo
Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.
• Active Oral Ethanol
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.

Locations

Country	Name	City	State
United States	Biological Studies Unit, VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Road Tracking Error		baseline, +20, +50, +120, +180 mins after start of alcohol administration
Secondary	Biphasic Alcohol Effects Scale (BAES)	A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication.	baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
Secondary	Visual Analog Scale (VAS)	Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states.	baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
Secondary	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.	baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
Secondary	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.	+40 mins after start of alcohol administration
Secondary	Number of Joints Scale	Subjects will be asked to rate the number of standard joints that they believe they have been administered.	baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
Secondary	Number of Drinks Scale	Subjects will be asked to rate the number of standard drinks that they believe they have been administered.	baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration