Marijuana Effects on Simulated Driving Performance

Alcohol Drinking Clinical Trial

Official title:

Marijuana Effects on Simulated Driving Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699540
• Other study ID #: 43636
• Secondary ID: R21DA045101-02
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: December 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the effects of various strains of marijuana on simulated driving performance; the effects of alcohol administration will also be examined to further understand how marijuana-induced driving changes compare to the effects of alcohol. Secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy, adult participants
• Ages 21-50
• History of marijuana use
• History of alcohol use

Exclusion Criteria:

• Clinically significant medical conditions
• Ongoing/significant drug use outside of marijuana and alcohol use

Related Conditions & MeSH terms

• Alcohol Drinking
• Cannabis
• Cannabis Use
• Marijuana
• Marijuana Abuse
• Marijuana Usage

Intervention

Drug:
• Marijuana
Experimental, non-therapeutic administration of active marijuana dose(s)
• Alcohol
Experimental, non-therapeutic administration of active alcohol dose(s)
• placebo alcohol
Experimental, non-therapeutic administration of inactive alcohol dose(s)
• Inactive marijuana
Experimental, non-therapeutic administration of inactive marijuana dose(s)

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Shanna Babalonis, PhD	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simulated Driving Performance	We will examine various features of driving acuity (e.g.,break latency, lane departures)	These outcomes will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)
Secondary	Subject- and Observer-Rated Outcomes	Participants will report the subjective effects of the drug dose(s) on standardized measures; trained observers rate participant outcomes on standardized scales	These outcomes (VAS scores) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)