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

Cannabis Clinical Trial

— THC-ETOH-III  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02710331
• Other study ID #: 1501015208.C
• 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 ethanol clamped at BAC 0.04% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) 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).

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Active Dronabinol
10 mg capsule of Dronabinol will be administered orally.
• Placebo
Control: no alcohol, administered for ~80 minutes.
• Placebo
Control: Placebo pill (no active cannabinoids) administered orally.
• Active Ethanol
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.

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	Change from Baseline: Road Tracking Error		baseline, +100, +210 mins after start of dronabinol administration
Secondary	Change from Baseline: Biphasic Alcohol Effects Scale (BAES)	A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication.	baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Secondary	Change from Baseline: Visual Analog Scale (VAS)	Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states.	baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Secondary	Change from Baseline: 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.	baseline, +120 mins after start of dronabinol administration
Secondary	Change from Baseline: 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, +60, +90, +210, +360 mins after start of dronabinol administration
Secondary	Change from Baseline: Number of Joints Scale	Subjects will be asked to rate the number of standard joints that they believe they have been administered.	baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Secondary	Change from Baseline: Number of Drinks Scale	Subjects will be asked to rate the number of standard drinks that they believe they have been administered.	baseline, +60, +90, +210, +360 mins after start of dronabinol administration