search
Back to results

Marijuana Effects on Simulated Driving Performance

Primary Purpose

Cannabis, Cannabis Use, Marijuana

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Marijuana
Alcohol
Sponsored by
Shanna Babalonis, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cannabis focused on measuring simulated driving, outpatient

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Active Marijuana Dose

Inactive Marijuana Dose

Active Alcohol Dose

Inactive Alcohol Dose

Arm Description

Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions

Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions

Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions

Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions

Outcomes

Primary Outcome Measures

Simulated Driving Performance
We will examine various features of driving acuity (e.g.,break latency, lane departures)

Secondary Outcome Measures

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

Full Information

First Posted
October 2, 2018
Last Updated
January 24, 2023
Sponsor
Shanna Babalonis, PhD
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT03699540
Brief Title
Marijuana Effects on Simulated Driving Performance
Official Title
Marijuana Effects on Simulated Driving Performance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shanna Babalonis, PhD
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 the effects of alcohol. Secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis, Cannabis Use, Marijuana, Marijuana Usage, Alcohol Drinking
Keywords
simulated driving, outpatient

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Within-subject, randomized, placebo-controlled, double-dummy, double-blind study
Masking
ParticipantInvestigator
Masking Description
Double-blind, double-dummy, placebo-controlled design
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Marijuana Dose
Arm Type
Experimental
Arm Description
Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions
Arm Title
Inactive Marijuana Dose
Arm Type
Placebo Comparator
Arm Description
Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions
Arm Title
Active Alcohol Dose
Arm Type
Active Comparator
Arm Description
Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions
Arm Title
Inactive Alcohol Dose
Arm Type
Placebo Comparator
Arm Description
Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions
Intervention Type
Drug
Intervention Name(s)
Marijuana
Other Intervention Name(s)
Cannabis, Placebo
Intervention Description
Experimental, non-therapeutic administration of active and inactive marijuana dose(s)
Intervention Type
Drug
Intervention Name(s)
Alcohol
Other Intervention Name(s)
Alcohol, Placebo
Intervention Description
Experimental, non-therapeutic administration of active and inactive alcohol dose(s)
Primary Outcome Measure Information:
Title
Simulated Driving Performance
Description
We will examine various features of driving acuity (e.g.,break latency, lane departures)
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)
Secondary Outcome Measure Information:
Title
Subject- and Observer-Rated Outcomes
Description
Participants will report the subjective effects of the drug dose(s) on standardized measures; trained observers rate participant outcomes on standardized scales
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share individual participant data with other outside researchers.

Learn more about this trial

Marijuana Effects on Simulated Driving Performance

We'll reach out to this number within 24 hrs