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Sedative-Anxiolytic Effects on Simulated Driving Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03297944
Recruitment Status : Completed
First Posted : September 29, 2017
Results First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marion Coe, University of Kentucky

Brief 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.

Condition or disease Intervention/treatment Phase
Psychomotor Impairment Drug: Alprazolam 2mg (2ALP/PLC) Drug: Alprazolam 1mg (1ALP/PLC) Drug: Alprazolam 0.5mg (0.5ALP/PLC) Drug: Zolpidem 10mg (ZOL/PLC) Drug: Placebo (PLC/PLC) Drug: Alprazolam 1mg (PLC/ALC) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Participants and outcomes assessors were masked with respect to each individual intervention.
Primary Purpose: Other
Official Title: Alprazolam and Simulated Driving Performance: Next Day Effects
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : October 25, 2018
Actual Study Completion Date : October 25, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Alprazolam

Arm Intervention/treatment
Experimental: All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
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.




Primary Outcome Measures :
  1. Standard Deviation of Lane Position (SLDP) [ Time Frame: 16 hours ]
    Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297944


Locations
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United States, Kentucky
Center on Drug and Alcohol Research
Lexington, Kentucky, United States, 40508
Sponsors and Collaborators
Marion Coe
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Marion Coe University of Kentucky
  Study Documents (Full-Text)

Documents provided by Marion Coe, University of Kentucky:
Informed Consent Form  [PDF] March 29, 2017

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Responsible Party: Marion Coe, Doctoral Candidate, University of Kentucky
ClinicalTrials.gov Identifier: NCT03297944    
Other Study ID Numbers: 16-0260-F6A
R36DA043714-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2017    Key Record Dates
Results First Posted: January 29, 2020
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Zolpidem
Alprazolam
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators