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Sedative-Anxiolytic Effects on Simulated Driving Performance

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ClinicalTrials.gov Identifier: NCT03297944
Recruitment Status : Completed
First Posted : September 29, 2017
Last Update Posted : May 15, 2019
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 Drug: Zolpidem Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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: 2ALP/PLC
2mg Alprazolam administered at night, placebo administered in the morning
Drug: Alprazolam
0.5 to 2mg administered at night or in the morning

Experimental: 1ALP/PLC
1mg Alprazolam administered at night, placebo administered in the morning
Drug: Alprazolam
0.5 to 2mg administered at night or in the morning

Experimental: 0.5ALP/PLC
0.5mg Alprazolam administered at night, placebo administered in the morning
Drug: Alprazolam
0.5 to 2mg administered at night or in the morning

Active Comparator: ZOL/PLC
10mg Zolpidem administered at night, placebo administered in the morning
Drug: Zolpidem
10mg administered at night or in the morning

Placebo Comparator: PLC/PLC
Placebo administered at night, placebo administered in the morning
Drug: Placebo
placebo administered at night and/or in the morning

Active Comparator: PLC/ALP
Placebo administered at night, 1mg alprazolam administered in the morning
Drug: Alprazolam
0.5 to 2mg administered at night or in the morning




Primary Outcome Measures :
  1. standard deviation of lane position [ Time Frame: 16 hours ]
    measure of swerving on the driving simulator



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

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Responsible Party: Marion Coe, Doctoral Candidate, University of Kentucky
ClinicalTrials.gov Identifier: NCT03297944     History of Changes
Other Study ID Numbers: 16-0260-F6A
R36DA043714-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
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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Zolpidem
Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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