Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study II (THC-ETOH-II)

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 inhaled cannabis; Drug: Active Oral Ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT02710097

1501015208.B

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 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.

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).
• Occasional current cannabis users.
• Experience with drinking 2 or more standard drinks of alcohol at least once in lifetime.
• Able to provide informed consent.

Exclusion criteria

• Cannabis naïve.
• Alcohol naïve.
• 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 inhaled cannabis

Drug: Placebo

Active THC and Active Ethanol

Experimental group

Treatment:

Drug: Active Oral Ethanol

Drug: Active inhaled cannabis

Placebo THC and Active Ethanol

Experimental group

Treatment:

Drug: Active Oral Ethanol

Drug: Placebo

Drug: Placebo

Placebo THC and Placebo Ethanol

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo