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Clinical trial

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

ID
Name
1501015208.B
Description
The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.
Trial arms
Trial start
2016-03-01
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Active inhaled cannabis
\~450 mg of active cannabis, which is roughly equivalent to smoking 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes via a vaporizer.
Arms:
Active THC and Active Ethanol, Active THC and Placebo Ethanol
Placebo
Approximately 4 drinks of orange juice or ginger ale covered with a trace amount of ethanol on the surface, each administered over approximately 10 minutes.
Arms:
Active THC and Placebo Ethanol, Placebo THC and Placebo Ethanol
Active Oral Ethanol
0.4 g/kg ethanol in orange juice or ginger ale to reach a target BrAC of approximately 0.04%. This dose is equivalent to approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.
Arms:
Active THC and Active Ethanol, Placebo THC and Active Ethanol
Placebo
No active cannabinoids. Administered over 20 minutes via a vaporizer.
Arms:
Placebo THC and Active Ethanol, Placebo THC and Placebo Ethanol
Size
40
Primary endpoint
Road Tracking Error
baseline, +20, +50, +120, +180 mins after start of alcohol administration
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-10-04

1 organization

Organization
Yale University