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

• Sponsor: Yale University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02710331
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 4
• Duration (Months): 81
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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: 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.

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Change from Baseline: Biphasic Alcohol Effects Scale (BAES) [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) [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biological Studies Unit, VA Connecticut Healthcare System	West Haven	Connecticut	United States	06516

Sponsors and Collaborators

• Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deepak C. D'Souza, Professor of Psychiatry, Yale University
• ClinicalTrials.gov Identifier: NCT02710331
• Other Study ID Numbers: 1501015208.C
• First Posted: Mar 16, 2016
• Last Update Posted: Dec 22, 2021
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Marijuana Abuse; Ethanol; Dronabinol

Study Results

No Results Posted as of Dec 22, 2021