Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III
NCT ID: NCT02710331
Last Updated: 2025-04-09
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 Dronabinol
10 mg capsule of Dronabinol will be administered orally.
Placebo
Control: no alcohol, administered for \~80 minutes.
Active THC and Active Ethanol
Active Dronabinol
10 mg capsule of Dronabinol will be administered orally.
Active Ethanol
Target BrAC of 0.04% reached over 20 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 2 drinks over 1 hour. Administered over a total of 80 minutes.
Placebo THC and Active Ethanol
Placebo
Control: Placebo pill (no active cannabinoids) administered orally.
Active Ethanol
Target BrAC of 0.04% reached over 20 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 2 drinks over 1 hour. Administered over a total of 80 minutes.
Placebo THC and Placebo Ethanol
Placebo
Control: no alcohol, administered for \~80 minutes.
Placebo
Control: Placebo pill (no active cannabinoids) administered orally.
Interventions
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Active Dronabinol
10 mg capsule of Dronabinol will be administered orally.
Placebo
Control: no alcohol, administered for \~80 minutes.
Placebo
Control: Placebo pill (no active cannabinoids) administered orally.
Active Ethanol
Target BrAC of 0.04% reached over 20 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 2 drinks over 1 hour. Administered over a total of 80 minutes.
Eligibility Criteria
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Inclusion Criteria
* Exposed to cannabis at least once.
* Exposed to alcohol at least once.
* Able to provide informed consent.
Exclusion Criteria
* Alcohol naïve
* Positive pregnancy screen
* Hearing deficits
* Sesame oil allergy
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.C
Identifier Type: -
Identifier Source: org_study_id
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