Sedative-Anxiolytic Effects on Simulated Driving Performance

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2018-10-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Psychomotor Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Participants and outcomes assessors were masked with respect to each individual intervention.

Study Groups

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All Participants

All participants received each intervention with alprazolam, zolpidem and placebo.

Group Type EXPERIMENTAL

Alprazolam 2mg (2ALP/PLC)

Intervention Type DRUG

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

Alprazolam 1mg (1ALP/PLC)

Intervention Type DRUG

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

Alprazolam 0.5mg (0.5ALP/PLC)

Intervention Type DRUG

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

Zolpidem 10mg (ZOL/PLC)

Intervention Type DRUG

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

Placebo (PLC/PLC)

Intervention Type DRUG

Placebo administered at night, placebo administered in the morning.

Alprazolam 1mg (PLC/ALC)

Intervention Type DRUG

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

Interventions

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Alprazolam 2mg (2ALP/PLC)

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

Intervention Type DRUG

Alprazolam 1mg (1ALP/PLC)

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

Intervention Type DRUG

Alprazolam 0.5mg (0.5ALP/PLC)

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

Intervention Type DRUG

Zolpidem 10mg (ZOL/PLC)

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

Intervention Type DRUG

Placebo (PLC/PLC)

Placebo administered at night, placebo administered in the morning.

Intervention Type DRUG

Alprazolam 1mg (PLC/ALC)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* valid driver's license
* english-speaking and literate

Exclusion Criteria

* using daily medication for chronic condition
* acute narrow angle glaucoma
* previous adverse experience with study drugs
* experiences motion sickness in response to driving simulator
* BMI \> 30
* women who are pregnant, lactating, or planning on becoming pregnant
* regular use of tobacco products
* current substance use disorder
* clinically significant ECG
* current ongoing psychiatric disorder

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes