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Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

NCT01257165 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-12-13

No results posted yet for this study

Summary

Zopiclone, a widely used hypnotic drug, is frequently found in blood samples taken from drivers suspected of driving under the influence. In this study, the investigators aim to correlate zopiclone serum concentrations with degrees of driving impairment in healthy volunteers by use of a validated driving simulator. The investigators also aim to compare their results with the results from a previous study that investigated zopiclone impairment of cognitive and psychometric tests.

Conditions

  • Automobile Driving

Interventions

DRUG

Zopiclone

Zopiclone pill 5 or 10 mg, given orally as a single dose.

DRUG

Ethanol

50 mg per 70 kg body weight, given orally as a single dose

DRUG

Placebo pill

Placebo pill identical to zopiclone pill, given orally as a single dose

DRUG

Placebo drink

Placebo drink, given orally as a single dose

Sponsors & Collaborators

  • SINTEF Health Research

    collaborator OTHER

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Norwegian Institute of Public Health

    collaborator OTHER_GOV

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Lars J Slørdal, MD, PhD · Norwegian University of Science and Technology

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-12-31
Completion
2012-12-31

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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 NCT01257165 on ClinicalTrials.gov