Marijuana Effects on Simulated Driving Performance

NCT03699540 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 43636R21DA045101-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Cannabis; Cannabis Use; Marijuana; Marijuana Usage; Alcohol Drinking

Keywords

simulated driving, outpatient

Outcome Measures

Primary Outcomes (1)

• Mean Peak for Standard Deviation in Lane Position (SDLP)

  Standard deviation of lane position (SDLP) of the car is the amount of weaving/swerving of the car in and out of the lane. It is a frequent metric for assessing driving ability.

  This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.

Secondary Outcomes (5)

• Subject-Rated Outcomes: Mean Peak Score for Driving Difficulty

  This outcome (VAS score) was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.

• Subject-Rated Outcome: Mean Peak Score for Drug and Alcohol Effect

  This outcome (VAS scores) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)

• Subject-Rated Outcome: Mean Peak Score for Difficulty Concentrating

  This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.

• Observer-Rated Outcome: Mean Peak Score for Relaxed

  This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.

• Observer-Rated Outcome: Mean Peak Score for Good Mood

  This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.

Study Arms (4)

Active Marijuana Dose

EXPERIMENTAL

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

Drug: Marijuana

Inactive Marijuana Dose

PLACEBO COMPARATOR

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

Drug: Inactive marijuana

Active Alcohol Dose

ACTIVE COMPARATOR

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

Drug: Alcohol

Inactive Alcohol Dose

PLACEBO COMPARATOR

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

Drug: placebo alcohol

Interventions

Marijuana DRUG

Experimental, non-therapeutic administration of active marijuana dose(s)

Also known as: Active cannabis

Active Marijuana Dose

Alcohol DRUG

Experimental, non-therapeutic administration of active alcohol dose(s)

Also known as: Active alcohol

Active Alcohol Dose

placebo alcohol DRUG

Experimental, non-therapeutic administration of inactive alcohol dose(s)

Inactive Alcohol Dose

Inactive marijuana DRUG

Experimental, non-therapeutic administration of inactive marijuana dose(s)

Also known as: inactive cannabis

Inactive Marijuana Dose

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanna Babalonis, PhD: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Alcohol Drinking

Interventions

nabiximols; Ethanol; Exercise

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Shanna Babalonis, Ph.D.
• Organization: University of Kentucky

babalonis@uky.edu

859-257-1881

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind, double-dummy, placebo-controlled design
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Within-subject, randomized, placebo-controlled, double-dummy, double-blind study

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 9, 2018
• Study Start: July 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)