Marijuana Effects on Simulated Driving Performance

NCT ID: NCT03699540

Last Updated: 2024-07-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cannabis Cannabis Use Marijuana Marijuana Usage Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Within-subject, randomized, placebo-controlled, double-dummy, double-blind study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind, double-dummy, placebo-controlled design

Study Groups

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Active Marijuana Dose

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

Group Type EXPERIMENTAL

Marijuana

Intervention Type DRUG

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

Inactive Marijuana Dose

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

Group Type PLACEBO_COMPARATOR

Inactive marijuana

Intervention Type DRUG

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

Active Alcohol Dose

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

Group Type ACTIVE_COMPARATOR

Alcohol

Intervention Type DRUG

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

Inactive Alcohol Dose

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

Group Type PLACEBO_COMPARATOR

placebo alcohol

Intervention Type DRUG

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

Interventions

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Marijuana

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

Intervention Type DRUG

Alcohol

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

Intervention Type DRUG

placebo alcohol

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

Intervention Type DRUG

Inactive marijuana

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

Intervention Type DRUG

Other Intervention Names

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Active cannabis Active alcohol inactive cannabis

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Shanna Babalonis, PhD

OTHER

Sponsor Role lead

Responsible Party

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Shanna Babalonis, PhD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R21DA045101-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

43636

Identifier Type: -

Identifier Source: org_study_id

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