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