Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition

Phase 1

Active, not recruiting

• Conditions: Cannabis; Alcohol Effect; Driving Under the Influence of Alcohol and Other Drugs
• Interventions: Drug: Active delta-9-THC; Drug: Placebo; Drug: Active Ethanol

• Registration Number: NCT02404688
• Lead Sponsor: Yale University

Brief Summary

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

Detailed Description

To study the effects of ethanol clamped at BAC 0.04% and THC (1.05 mg in a 70 kg individual) on driving.

Study Timeline

• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Study Start: 2015-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active THC and Placebo Ethanol	Active delta-9-THC	-
Active THC and Active Ethanol	Active Ethanol	-
Placebo THC and Active Ethanol	Placebo	-
Placebo THC and Placebo Ethanol	Placebo	-
Active THC and Placebo Ethanol	Placebo	-
Placebo THC and Active Ethanol	Active Ethanol	-
Active THC and Active Ethanol	Active delta-9-THC	-

Primary Outcome Measures

Name	Time	Method
Road Tracking Error	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 Outcome Measures

Name	Time	Method
Cognitive Test Battery	+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.
Biphasic Alcohol Effects Scale (BAES)	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.
Visual Analog Scale (VAS)	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.
Willingness to Drive Scale	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.
Number of Joints Scale	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.
Number of Drinks Scale	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.

Trial Locations

Locations (1)

Biological Studies Unit, VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States