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

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: Placebo; Drug: Active delta-9-THC; Drug: Active Ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT02404688

1501015208

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% and THC (1.05 mg in a 70 kg individual) 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 naive.
• Alcohol naive.
• Positive pregnancy screen
• Hearing deficits.

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 delta-9-THC

Drug: Placebo

Active THC and Active Ethanol

Experimental group

Treatment:

Drug: Active Ethanol

Drug: Active delta-9-THC

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