Sedative-Anxiolytic Effects on Simulated Driving Performance

Marion Coe

Status and phase: Completed; Phase 4

Conditions: Psychomotor Impairment

Treatments: Drug: Alprazolam 1mg (1ALP/PLC); Drug: Alprazolam 1mg (PLC/ALC); Drug: Alprazolam 2mg (2ALP/PLC); Drug: Zolpidem 10mg (ZOL/PLC); Drug: Placebo (PLC/PLC); Drug: Alprazolam 0.5mg (0.5ALP/PLC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03297944

R36DA043714-01A1 (U.S. NIH Grant/Contract)

16-0260-F6A

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

All Participants

Experimental group

Description:

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

Treatment:

Drug: Zolpidem 10mg (ZOL/PLC)

Drug: Placebo (PLC/PLC)

Drug: Alprazolam 1mg (1ALP/PLC)

Drug: Alprazolam 1mg (PLC/ALC)

Drug: Alprazolam 0.5mg (0.5ALP/PLC)

Drug: Alprazolam 2mg (2ALP/PLC)