Marijuana Effects on Simulated Driving Performance

December 6, 2023 updated by: Shanna Babalonis, PhD
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Marijuana Dose
Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions
Drug: Marijuana
Experimental, non-therapeutic administration of active marijuana dose(s)
Other Names:
  • Active cannabis
Placebo Comparator: Inactive Marijuana Dose
Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions
Drug: Inactive marijuana
Experimental, non-therapeutic administration of inactive marijuana dose(s)
Other Names:
  • inactive cannabis
Active Comparator: Active Alcohol Dose
Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions
Drug: Alcohol
Experimental, non-therapeutic administration of active alcohol dose(s)
Other Names:
  • Active alcohol
Placebo Comparator: Inactive Alcohol Dose
Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions
Drug: placebo alcohol
Experimental, non-therapeutic administration of inactive alcohol dose(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Simulated Driving Performance
Time Frame: These outcomes will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject- and Observer-Rated Outcomes
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanna Babalonis, PhD

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

October 2, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43636
  • R21DA045101-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share individual participant data with other outside researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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