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% and THC (1.05 mg in a 70 kg individual) on driving.
Interventions
Low dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or joint. Administered over 20 minutes.
DRUGPlacebo
Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 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 naive. * Alcohol naive. * Positive pregnancy screen * Hearing deficits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Road Tracking Error | baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion | changes in road tracking errors between timepoints to assess the effects of alcohol and THC on road tracking errors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion | Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states. |
| Cognitive Test Battery | +40 mins after start of alcohol and THC infusion | 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. |
| Biphasic Alcohol Effects Scale (BAES) | baseline, +20, +50, +120, +180, +240 mins after start of alcohol and THC infusion | A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication. |
| Number of Joints Scale | baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion | Subjects will be asked to rate the number of standard joints that they believe they have been administered. |
| Number of Drinks Scale | baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion | Subjects will be asked to rate the number of standard drinks that they believe they have been administered. |
| Willingness to Drive Scale | baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion | 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