Cannabis, Alcohol Effect, Driving Under the Influence of Alcohol and Other Drugs
Conditions
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.
Interventions
10 mg capsule of Dronabinol will be administered orally.
DRUGPlacebo
Control: no alcohol, administered for \ 80 minutes.
DRUGActive 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.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline: Road Tracking Error | baseline, +100, +210 mins after start of dronabinol administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline: Visual Analog Scale (VAS) | baseline, +60, +90, +210, +360 mins after start of dronabinol administration | Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states. |
| Change from Baseline: Cognitive Test Battery | baseline, +120 mins after start of dronabinol administration | Several computer tasks will be administered to assess alcohol and THC effects on driving related cognition, including: visual vigilance, visual motor function, attention and working memory, and processing speed. |
| Change from Baseline: Biphasic Alcohol Effects Scale (BAES) | baseline, +60, +90, +210, +360 mins after start of dronabinol administration | A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication. |
| Change from Baseline: Number of Joints Scale | baseline, +60, +90, +210, +360 mins after start of dronabinol administration | Subjects will be asked to rate the number of standard joints that they believe they have been administered. |
| Change from Baseline: Number of Drinks Scale | baseline, +60, +90, +210, +360 mins after start of dronabinol administration | Subjects will be asked to rate the number of standard drinks that they believe they have been administered. |
| Change from Baseline: Willingness to Drive Scale | baseline, +60, +90, +210, +360 mins after start of dronabinol administration | Subjects will be asked to rate their willingness to drive at their current state in the context of various scenarios including willingness to drive from testing facility to a number of destinations that are different driving distances. |
Countries
United States
Outcome results
None listed