Alcohol Effect, Cannabis, 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 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.
Interventions
\~450 mg of active cannabis, which is roughly equivalent to smoking 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes via a vaporizer.
DRUGPlacebo
Approximately 4 drinks of orange juice or ginger ale covered with a trace amount of ethanol on the surface, each administered over approximately 10 minutes.
0.4 g/kg ethanol in orange juice or ginger ale to reach a target BrAC of approximately 0.04%. This dose is equivalent to approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 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). * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Road Tracking Error | baseline, +20, +50, +120, +180 mins after start of alcohol administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biphasic Alcohol Effects Scale (BAES) | baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration | A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication |
| Visual Analog Scale (VAS) | baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration | 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 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. |
| Willingness to Drive Scale | baseline, +20, +50, +120, +180, +240 mins after start of alcohol 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. |
| Number of Joints Scale | baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration | 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, +240 mins after start of alcohol administration | Subjects will be asked to rate the number of standard drinks that they believe they have been administered. |
Countries
United States
Outcome results
None listed