Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study II

ID: NCT02710097
Status: Active, not recruiting
Phase: Phase 1
Start Date: March 01, 2016
First Submitted: March 10, 2016
Last Updated: June 20, 2017
Results: N/A
Organization: Yale University
Sponsors & Collaborators: Yale University
Location: United States
Conditions: Cannabis, Alcohol Effect, Driving Under the Influence of Alcohol and Other Drugs
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for 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.

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.
Condition or disease Intervention/treatment Phase

Alcohol Effect

Cannabis

Driving Under the Influence of Alcohol and Other Drugs

Drug: Active inhaled cannabis
Other Names
Drug: Placebo
Other Names
Drug: Active Oral Ethanol
Other Names
Drug: Placebo
Other Names
Phase 1

Tracking Information

First Submitted DateMarch 10, 2016
Last Update Posted DateJune 20, 2017
Start DateMarch 01, 2016
Anticipated Completion DateDecember 01, 2020
Primary Completion DateDecember 01, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Road Tracking Error [Time Frame: baseline, +20, +50, +120, +180 mins after start of alcohol administration]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Biphasic Alcohol Effects Scale (BAES) [Time Frame: 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) [Time Frame: 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 [Time Frame: +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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleEthanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study II
Official TitleEthanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study II
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 TypeInterventional
Study PhasePhase 1
Estimated Enrollment
40
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Quadruple
Primary Purpose
Basic Science
Conditions
Alcohol Effect
Cannabis
Driving Under the Influence of Alcohol and Other Drugs
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Active inhaled cannabis

~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.

Other Names
Drug: Placebo

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.

Other Names
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 approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.

Other Names
Drug: Placebo

No active cannabinoids. Administered over 20 minutes via a vaporizer.

Other Names
Study Groups/Cohorts
Active THC and Placebo Ethanol

Active THC and Active Ethanol

Placebo THC and Active Ethanol

Placebo THC and Placebo Ethanol

Study Arms
Experimental Active THC and Active Ethanol
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 approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.

Experimental Active THC and Active Ethanol
Drug : Active inhaled cannabis
~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.

Experimental Active THC and Placebo Ethanol
Drug : Placebo
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.

Experimental Active THC and Placebo Ethanol
Drug : Active inhaled cannabis
~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.

Experimental Placebo THC and Active Ethanol
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 approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.

Experimental Placebo THC and Active Ethanol
Drug : Placebo
No active cannabinoids. Administered over 20 minutes via a vaporizer.

Placebo Comparator Placebo THC and Placebo Ethanol
Drug : Placebo
No active cannabinoids. Administered over 20 minutes via a vaporizer.

Placebo Comparator Placebo THC and Placebo Ethanol
Drug : Placebo
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.

Arm Intervention/Treatment
Experimental Active THC and Active Ethanol
Drug : Active Oral Ethanol
Experimental Active THC and Active Ethanol
Drug : Active inhaled cannabis
Experimental Active THC and Placebo Ethanol
Drug : Placebo
Experimental Active THC and Placebo Ethanol
Drug : Active inhaled cannabis
Experimental Placebo THC and Active Ethanol
Drug : Active Oral Ethanol
Experimental Placebo THC and Active Ethanol
Drug : Placebo
Placebo Comparator Placebo THC and Placebo Ethanol
Drug : Placebo
Placebo Comparator Placebo THC and Placebo Ethanol
Drug : Placebo

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment40
Completion DateDecember 01, 2020
Eligibility 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.
GenderAll
Age21 Years to 55 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02710097
Other Study ID Numbers
1501015208.B
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyDeepak C. D'Souza, Yale University
Study Sponsor
Yale University
Collaborators
Not Available
Investigators
Not Available