Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I
NCT ID: NCT02709954
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2016-03-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Active THC and Placebo Ethanol
Active inhaled delta-9-THC
Low dose THC (\~4 mg), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes via a vaporizer.
Placebo
Control: Approximately 4 drinks of orange juice or ginger ale covered by a trace amount of ethanol on the surface, each administered over approximately 10 minutes.
Active THC and Active Ethanol
Active inhaled delta-9-THC
Low dose THC (\~4 mg), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes via a vaporizer.
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 consuming approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.
Placebo THC and Active Ethanol
Placebo
Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.
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 consuming approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.
Placebo THC and Placebo Ethanol
Placebo
Control: Approximately 4 drinks of orange juice or ginger ale covered by a trace amount of ethanol on the surface, each administered over approximately 10 minutes.
Placebo
Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.
Interventions
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Active inhaled delta-9-THC
Low dose THC (\~4 mg), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes via a vaporizer.
Placebo
Control: Approximately 4 drinks of orange juice or ginger ale covered by a trace amount of ethanol on the surface, each administered over approximately 10 minutes.
Placebo
Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.
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 consuming approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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
* Alcohol naïve.
* Positive pregnancy screen
* Hearing deficits.
21 Years
55 Years
ALL
Yes
Sponsors
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Yale University
OTHER
Responsible Party
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Deepak C. D'Souza
Professor of Psychiatry
Locations
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Biological Studies Unit, VA Connecticut Healthcare System
West Haven, Connecticut, United States
Countries
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Other Identifiers
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1501015208.A
Identifier Type: -
Identifier Source: org_study_id
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