Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study II
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Yale University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 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 oral ethanol (target BAC of ~0.04g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized cannabis (~450 mg cannabis plant material at a THC concentration of ~1.7%; roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") 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).
- •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.
Arms & Interventions
Active THC and Placebo Ethanol
Intervention: Active inhaled cannabis (Drug)
Active THC and Placebo Ethanol
Intervention: Placebo (Drug)
Active THC and Active Ethanol
Intervention: Active inhaled cannabis (Drug)
Active THC and Active Ethanol
Intervention: Active Oral Ethanol (Drug)
Placebo THC and Active Ethanol
Intervention: Active Oral Ethanol (Drug)
Placebo THC and Active Ethanol
Intervention: Placebo (Drug)
Placebo THC and Placebo Ethanol
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Road Tracking Error
Time Frame: baseline, +20, +50, +120, +180 mins after start of alcohol administration
Secondary Outcomes
- Number of Drinks Scale(baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration)
- Cognitive Test Battery(+40 mins after start of alcohol administration)
- Willingness to Drive Scale(baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration)
- Biphasic Alcohol Effects Scale (BAES)(baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration)
- Visual Analog Scale (VAS)(baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration)
- Number of Joints Scale(baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration)
Investigators
Deepak C. D'Souza
Professor of Psychiatry
Yale University