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

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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 Oral Ethanol
Drug: Placebo
Drug: Active inhaled delta-9-THC

Study type

Interventional

Funder types

Other

Identifiers

NCT02709954
1501015208.A

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 (a target BAC of ~0.04 g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized THC (4 mg of THC dissolved in an ethanolic solution; 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

40 participants in 4 patient groups, including a placebo group

Active THC and Placebo Ethanol
Experimental group
Treatment:
Drug: Placebo
Drug: Active inhaled delta-9-THC
Active THC and Active Ethanol
Experimental group
Treatment:
Drug: Active inhaled delta-9-THC
Drug: Active Oral Ethanol
Placebo THC and Active Ethanol
Experimental group
Treatment:
Drug: Placebo
Drug: Active Oral Ethanol
Placebo THC and Placebo Ethanol
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Laura Cadavid, BS; Christina Luddy, BS

Data sourced from clinicaltrials.gov

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