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

Phase 1

Active, not recruiting

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

• Registration Number: NCT02710097
• 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 oral ethanol (target BAC of \~0.04g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized cannabis (\~450 mg cannabis plant material at a THC concentration of \~1.7%; roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") 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: 2023-10-02
• 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).
• Occasional current cannabis users.
• Experience with drinking 2 or more standard drinks of alcohol at least once in lifetime.
• Able to provide informed consent.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active THC and Active Ethanol	Active Oral Ethanol	-
Active THC and Placebo Ethanol	Placebo	-
Active THC and Active Ethanol	Active inhaled cannabis	-
Active THC and Placebo Ethanol	Active inhaled cannabis	-
Placebo THC and Placebo Ethanol	Placebo	-
Placebo THC and Active Ethanol	Active Oral Ethanol	-
Placebo THC and Active Ethanol	Placebo	-

Primary Outcome Measures

Name	Time	Method
Road Tracking Error	baseline, +20, +50, +120, +180 mins after start of alcohol administration

Secondary Outcome Measures

Name	Time	Method
Number of Drinks Scale	baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration	Subjects will be asked to rate the number of standard drinks that they believe they have been administered.
Cognitive Test Battery	+40 mins after start of alcohol 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.
Willingness to Drive Scale	baseline, +20, +50, +120, +180, +240 mins after start of alcohol 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.
Biphasic Alcohol Effects Scale (BAES)	baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration	A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication
Visual Analog Scale (VAS)	baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration	Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states.
Number of Joints Scale	baseline, +20, +50, +120, +180, +240 mins after start of alcohol 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