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Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

NCT ID: NCT01257165

Last Updated: 2013-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Automobile Driving

Keywords

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Automobile driving Zopiclone Drug safety Traffic accidents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zopiclone 5 mg

Zopiclone 5 mg pill + placebo pill + placebo drink

Group Type EXPERIMENTAL

Zopiclone

Intervention Type DRUG

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

Placebo pill

Intervention Type DRUG

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

Placebo drink

Intervention Type DRUG

Placebo drink, given orally as a single dose

Zopiclone 10 mg

2 x zopiclone 5 mg pills + placebo drink

Group Type EXPERIMENTAL

Zopiclone

Intervention Type DRUG

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

Placebo drink

Intervention Type DRUG

Placebo drink, given orally as a single dose

Ethanol 0.8 g/L

2 x placebo pills + ethanol 50 g/70 kg

Group Type ACTIVE_COMPARATOR

Ethanol

Intervention Type DRUG

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

Placebo pill

Intervention Type DRUG

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

Placebo

2 x placebo pills + placebo drink

Group Type PLACEBO_COMPARATOR

Placebo pill

Intervention Type DRUG

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

Placebo drink

Intervention Type DRUG

Placebo drink, given orally as a single dose

Interventions

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Zopiclone

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

Intervention Type DRUG

Ethanol

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

Intervention Type DRUG

Placebo pill

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

Intervention Type DRUG

Placebo drink

Placebo drink, given orally as a single dose

Intervention Type DRUG

Other Intervention Names

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Imovane Zopiklon Zopiclon Alcohol Ethyl alcohol

Eligibility Criteria

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Inclusion Criteria

* Male
* Caucasian ethnicity
* Age 25-35 years
* Possession of a driver's licence for at least five years

Exclusion Criteria

* Score ≥ 2 on the modified Apfel-scale to assess risk for motion sickness(\*)
* History of driving under the influence of alcohol and/or illicit substances
* History or presence of alcohol or illicit drug abuse
* Former abnormal reaction to any hypnotic drug
* History of strong averse reactions to blood sampling procedures
* Regular (daily) intake of any prescribed drug, or intake of grapefruit juice or herbal remedies that can influence the metabolism of zopiclone (e.g. St John's wort)
* History of severe allergic reactions, or significant mental, cardiovascular, renal or hepatic disorder, or other significant disease as judged by the investigators
* Detection of any drugs of abuse on pre-session urine drug screening

(\*)Modified Apfel-criteria for prediction of postoperative nausea/vomiting:

1. Smoker? yes 0, no 1
2. History of nausea and/or vomiting following surgery, dental treatment, injections or similar procedures? yes 0, no 1
3. History of car sickness after 10 years of age? yes 0, no 1

A score of two or more points excludes participation.
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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SINTEF Health Research

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars J Slørdal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Countries

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Norway

Other Identifiers

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60R020.05

Identifier Type: -

Identifier Source: org_study_id