Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition

ID: NCT02404688
Status: Recruiting
Phase: Phase 1
Start Date: February 01, 2015
First Submitted: March 26, 2015
Last Updated: June 21, 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
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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 ethanol clamped at BAC 0.04% and THC (1.05 mg in a 70 kg individual) on driving.
Condition or disease Intervention/treatment Phase

Alcohol Effect

Cannabis

Driving Under the Influence of Alcohol and Other Drugs

Drug: Active delta-9-THC
Other Names
Drug: Placebo
Other Names
Drug: Active Ethanol
Other Names
Drug: Placebo
Other Names
Phase 1

Tracking Information

First Submitted DateMarch 26, 2015
Last Update Posted DateJune 21, 2017
Start DateFebruary 01, 2015
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 and THC infusion]

    changes in road tracking errors between timepoints to assess the effects of alcohol and THC on road tracking errors.

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 and THC infusion]

    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 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 [Time Frame: +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.

  • Willingness to Drive Scale [Time Frame: 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.

  • Number of Joints Scale [Time Frame: 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 [Time Frame: 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleEthanol and Cannabinoid Effects on Simulated Driving and Related Cognition
Official TitleEthanol and Cannabinoid Effects on Simulated Driving and Related Cognition
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.

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 delta-9-THC

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.

Other Names
Drug: Placebo

Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes.

Other Names
Drug: Active 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.

Other Names
Drug: Placebo

Control: no alcohol, administered for a total of 80 minutes.

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 delta-9-THC
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.

Experimental Active THC and Active Ethanol
Drug : Active 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.

Experimental Active THC and Placebo Ethanol
Drug : Placebo
Control: no alcohol, administered for a total of 80 minutes.

Experimental Active THC and Placebo Ethanol
Drug : Active delta-9-THC
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.

Experimental Placebo THC and Active Ethanol
Drug : Active 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.

Experimental Placebo THC and Active Ethanol
Drug : Placebo
Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes.

Placebo Comparator Placebo THC and Placebo Ethanol
Drug : Placebo
Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes.

Placebo Comparator Placebo THC and Placebo Ethanol
Drug : Placebo
Control: no alcohol, administered for a total of 80 minutes.

Arm Intervention/Treatment
Experimental Active THC and Active Ethanol
Drug : Active delta-9-THC
Experimental Active THC and Active Ethanol
Drug : Active Ethanol
Experimental Active THC and Placebo Ethanol
Drug : Placebo
Experimental Active THC and Placebo Ethanol
Drug : Active delta-9-THC
Experimental Placebo THC and Active Ethanol
Drug : Active 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:Recruiting
Enrollment40
Completion DateDecember 01, 2020
Eligibility Criteria: 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.
GenderAll
Age21 Years to 55 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02404688
Other Study ID Numbers
1501015208
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