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Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study II (THC-ETOH-II)

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ClinicalTrials.gov Identifier: NCT02710097
Recruitment Status : Active, not recruiting
First Posted : March 16, 2016
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

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
Cannabis Alcohol Effect Driving Under the Influence of Alcohol and Other Drugs Drug: Active inhaled cannabis Drug: Placebo Drug: Active Oral Ethanol Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study II
Study Start Date : March 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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.

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 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.

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: 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.

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.

Drug: Placebo
No active cannabinoids. Administered over 20 minutes via a vaporizer.




Primary Outcome Measures :
  1. Road Tracking Error [ Time Frame: baseline, +20, +50, +120, +180 mins after start of alcohol administration ]

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710097


Locations
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United States, Connecticut
Biological Studies Unit, VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University

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Responsible Party: Deepak C. D'Souza, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02710097     History of Changes
Other Study ID Numbers: 1501015208.B
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs