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Verified June 2016 by Yale University

Sponsor:

Information provided by (Responsible Party):

Deepak C. D’Souza, Yale University

ClinicalTrials.gov Identifier:

NCT02710331

First received: March 10, 2016

Last updated: June 20, 2016

Last verified: June 2016

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III

Primary Outcome Measures:

  • Change from Baseline: Road Tracking Error [ Time Frame: baseline, +100, +210 mins after start of dronabinol administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Change from Baseline: Biphasic Alcohol Effects Scale (BAES) [ Time Frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration ] [ Designated as safety issue: No ]

    A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication.

  • Change from Baseline: Visual Analog Scale (VAS) [ Time Frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration ] [ Designated as safety issue: No ]

    Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states.

  • Change from Baseline: Cognitive Test Battery [ Time Frame: baseline, +120 mins after start of dronabinol administration ] [ Designated as safety issue: No ]

    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.

  • Change from Baseline: Willingness to Drive Scale [ Time Frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration ] [ Designated as safety issue: No ]

    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.

  • Change from Baseline: Number of Joints Scale [ Time Frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration ] [ Designated as safety issue: No ]

    Subjects will be asked to rate the number of standard joints that they believe they have been administered.

  • Change from Baseline: Number of Drinks Scale [ Time Frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration ] [ Designated as safety issue: No ]

    Subjects will be asked to rate the number of standard drinks that they believe they have been administered.

Estimated Enrollment: 40
Study Start Date: March 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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.

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.

Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02710331

Biological Studies Unit, VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Contact: Esra Sefik, B.A.    203-932-5711 ext 2557    esra.sefik@nullyale.edu   
Principal Investigator: Deepak C. D’Souza, M.D.         

Yale University

Responsible Party: Deepak C. D’Souza, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02710331     History of Changes
Other Study ID Numbers: 1501015208.C 
Study First Received: March 10, 2016
Last Updated: June 20, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:

Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Dronabinol
Ethanol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on September 13, 2016