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Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III (THC-ETOH-III)

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ClinicalTrials.gov Identifier: NCT02710331
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : July 17, 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 Dronabinol Drug: Placebo Drug: Active Ethanol Phase 1

Detailed Description:
To study the effects of ethanol clamped at BAC 0.04% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) 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: Substudy III
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 Dronabinol
10 mg capsule of Dronabinol will be administered orally.

Drug: Placebo
Control: no alcohol, administered for ~80 minutes.

Experimental: Active THC and Active Ethanol Drug: Active Dronabinol
10 mg capsule of Dronabinol will be administered orally.

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: Placebo pill (no active cannabinoids) administered orally.

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.

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

Drug: Placebo
Control: Placebo pill (no active cannabinoids) administered orally.




Primary Outcome Measures :
  1. Change from Baseline: Road Tracking Error [ Time Frame: baseline, +100, +210 mins after start of dronabinol administration ]

Secondary Outcome Measures :
  1. Change from Baseline: Biphasic Alcohol Effects Scale (BAES) [ Time Frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration ]
    A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication.

  2. Change from Baseline: Visual Analog Scale (VAS) [ Time Frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration ]
    Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states.

  3. Change from Baseline: Cognitive Test Battery [ Time Frame: baseline, +120 mins after start of dronabinol 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. Change from Baseline: Willingness to Drive Scale [ Time Frame: baseline, +60, +90, +210, +360 mins after start of dronabinol 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. Change from Baseline: Number of Joints Scale [ Time Frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration ]
    Subjects will be asked to rate the number of standard joints that they believe they have been administered.

  6. Change from Baseline: Number of Drinks Scale [ Time Frame: baseline, +60, +90, +210, +360 mins after start of dronabinol 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).
  • Exposed to cannabis at least once.
  • Exposed to alcohol at least once.
  • Able to provide informed consent.

Exclusion Criteria:

  • Cannabis naïve
  • Alcohol naïve
  • Positive pregnancy screen
  • Hearing deficits
  • Sesame oil allergy

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): NCT02710331


Contacts
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Contact: Leigh Taylor Flynn, BS 203-932-5711 ext 2557 leigh.flynn@yale.edu
Contact: Christina Luddy, BS 203-932-5711 ext 4549 christina.luddy@yale.edu

Locations
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United States, Connecticut
Biological Studies Unit, VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Neeraj Madivala, B.A.    203-932-5711 ext 4650    neeraj.madivala@yale.edu   
Principal Investigator: Deepak C. D'Souza, M.D.         
Sponsors and Collaborators
Yale University

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Responsible Party: Deepak C. D'Souza, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02710331     History of Changes
Other Study ID Numbers: 1501015208.C
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Dronabinol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists