Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III
THC-ETOH-III
1 other identifier
interventional
40
1 country
1
Brief Summary
The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 10, 2016
CompletedFirst Posted
Study publicly available on registry
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 27, 2026
April 1, 2026
10.8 years
March 10, 2016
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline: Road Tracking Error
baseline, +100, +210 mins after start of dronabinol administration
Secondary Outcomes (6)
Change from Baseline: Biphasic Alcohol Effects Scale (BAES)
baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Change from Baseline: Visual Analog Scale (VAS)
baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Change from Baseline: Cognitive Test Battery
baseline, +120 mins after start of dronabinol administration
Change from Baseline: Willingness to Drive Scale
baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Change from Baseline: Number of Joints Scale
baseline, +60, +90, +210, +360 mins after start of dronabinol administration
- +1 more secondary outcomes
Study Arms (4)
Active THC and Placebo Ethanol
EXPERIMENTALActive THC and Active Ethanol
EXPERIMENTALPlacebo THC and Active Ethanol
EXPERIMENTALPlacebo THC and Placebo Ethanol
PLACEBO COMPARATORInterventions
10 mg capsule of Dronabinol will be administered orally.
Control: no alcohol, administered for \~80 minutes.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Cannabis naïve
- Alcohol naïve
- Positive pregnancy screen
- Hearing deficits
- Sesame oil allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Biological Studies Unit, VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
March 10, 2016
First Posted
March 16, 2016
Study Start
March 1, 2016
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 27, 2026
Record last verified: 2026-04