NCT02710331Active, not recruitingPhase 1
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Yale University
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change from Baseline: Road Tracking Error
Study Overview
Brief Summary
The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.
Detailed Description
To study the effects of ethanol clamped at BAC 0.04% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) on driving.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Males or females 21 to 55 years of age (extremes included).
- •Exposed to cannabis at least once.
- •Exposed to alcohol at least once.
- •Able to provide informed consent.
Exclusion Criteria
- •Cannabis naïve
- •Alcohol naïve
- •Positive pregnancy screen
- •Hearing deficits
- •Sesame oil allergy
Arms & Interventions
Active THC and Placebo Ethanol
Experimental
Intervention: Active Dronabinol (Drug)
Active THC and Placebo Ethanol
Experimental
Intervention: Placebo (Drug)
Active THC and Active Ethanol
Experimental
Intervention: Active Dronabinol (Drug)
Active THC and Active Ethanol
Experimental
Intervention: Active Ethanol (Drug)
Placebo THC and Active Ethanol
Experimental
Intervention: Placebo (Drug)
Placebo THC and Active Ethanol
Experimental
Intervention: Active Ethanol (Drug)
Placebo THC and Placebo Ethanol
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change from Baseline: Road Tracking Error
Time Frame: baseline, +100, +210 mins after start of dronabinol administration
Secondary Outcomes
- Change from Baseline: Biphasic Alcohol Effects Scale (BAES)(baseline, +60, +90, +210, +360 mins after start of dronabinol administration)
- Change from Baseline: Visual Analog Scale (VAS)(baseline, +60, +90, +210, +360 mins after start of dronabinol administration)
- Change from Baseline: Cognitive Test Battery(baseline, +120 mins after start of dronabinol administration)
- Change from Baseline: Willingness to Drive Scale(baseline, +60, +90, +210, +360 mins after start of dronabinol administration)
- Change from Baseline: Number of Joints Scale(baseline, +60, +90, +210, +360 mins after start of dronabinol administration)
- Change from Baseline: Number of Drinks Scale(baseline, +60, +90, +210, +360 mins after start of dronabinol administration)
Investigators
Deepak C. D'Souza
Professor of Psychiatry
Yale University
Study Sites (2)
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