Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III (THC-ETOH-III)

Yale University

Status and phase: Active, not recruiting; Phase 1

Conditions: Alcohol Effect; Cannabis; Driving Under the Influence of Alcohol and Other Drugs

Treatments: Drug: Active Ethanol; Drug: Active Dronabinol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02710331

1501015208.C

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups, including a placebo group

Active THC and Placebo Ethanol

Experimental group

Treatment:

Drug: Placebo

Drug: Active Dronabinol

Drug: Placebo

Active THC and Active Ethanol

Experimental group

Treatment:

Drug: Active Dronabinol

Drug: Active Ethanol

Placebo THC and Active Ethanol

Experimental group

Treatment:

Drug: Placebo

Drug: Active Ethanol

Drug: Placebo

Placebo THC and Placebo Ethanol

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo