THC-ETOH-I: Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I
Study Details
Study Description
Brief Summary
The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
To study the effects of oral ethanol (a target BAC of ~0.04 g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized THC (4 mg of THC dissolved in an ethanolic solution; equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") on driving.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active THC and Placebo Ethanol
|
Drug: Active inhaled delta-9-THC
Low dose THC (~4 mg), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes via a vaporizer.
Drug: Placebo
Control: Approximately 4 drinks of orange juice or ginger ale covered by a trace amount of ethanol on the surface, each administered over approximately 10 minutes.
|
| Experimental: Active THC and Active Ethanol
|
Drug: Active inhaled delta-9-THC
Low dose THC (~4 mg), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes via a vaporizer.
Drug: Active Oral Ethanol
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 consuming approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.
|
| Experimental: Placebo THC and Active Ethanol
|
Drug: Placebo
Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.
Drug: Active Oral Ethanol
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 consuming approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.
|
| Placebo Comparator: Placebo THC and Placebo Ethanol
|
Drug: Placebo
Control: Approximately 4 drinks of orange juice or ginger ale covered by a trace amount of ethanol on the surface, each administered over approximately 10 minutes.
Drug: Placebo
Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.
|
Outcome Measures
Primary Outcome Measures
- Road Tracking Error [baseline, +20, +50, +120, +180 mins after start of alcohol administration]
Secondary Outcome Measures
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Biological Studies Unit, VA Connecticut Healthcare System | West Haven | Connecticut | United States | 06516 |
Sponsors and Collaborators
- Yale University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1501015208.A