MedTrace Logo

Sedative-Anxiolytic Effects on Simulated Driving Performance

NCT03297944 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-01-29

Study results available
· View outcomes & findings →

Summary

This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed or in the morning before using a driving simulator to assess impairment.

Conditions

  • Psychomotor Impairment

Interventions

DRUG

Alprazolam 2mg (2ALP/PLC)

2mg alprazolam administered at night, placebo administered in the morning.

DRUG

Alprazolam 1mg (1ALP/PLC)

1mg alprazolam administered at night, placebo administered in the morning.

DRUG

Alprazolam 0.5mg (0.5ALP/PLC)

0.5mg alprazolam administered at night, placebo administered in the morning.

DRUG

Zolpidem 10mg (ZOL/PLC)

10mg alprazolam administered at night, placebo administered in the morning.

DRUG

Placebo (PLC/PLC)

Placebo administered at night, placebo administered in the morning.

DRUG

Alprazolam 1mg (PLC/ALC)

Placebo administered at night, 1mg alprazolam administered in the morning.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Marion Coe

    lead OTHER

Principal Investigators

  • Marion Coe · University of Kentucky

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2018-10-25
Completion
2018-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03297944 on ClinicalTrials.gov