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

Phase 1

Active, not recruiting

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

• Registration Number: NCT02710331
• 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% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) on driving.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-10
• Study First Posted: 2016-03-16
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01
• 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.

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Exclusion Criteria

• Cannabis naïve
• Alcohol naïve
• Positive pregnancy screen
• Hearing deficits
• Sesame oil allergy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active THC and Placebo Ethanol	Active Dronabinol	-
Active THC and Placebo Ethanol	Placebo	-
Active THC and Active Ethanol	Active Dronabinol	-
Placebo THC and Active Ethanol	Placebo	-
Placebo THC and Active Ethanol	Active Ethanol	-
Placebo THC and Placebo Ethanol	Placebo	-
Active THC and Active Ethanol	Active Ethanol	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline: Road Tracking Error	baseline, +100, +210 mins after start of dronabinol administration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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