Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

NCT01257165 | Withdrawn

• 1 other identifier: 60R020.05
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Automobile driving; Zopiclone; Drug safety; Traffic accidents

Outcome Measures

Primary Outcomes (3)

• Standard deviation of lateral position (SDLP) on road

  SDLP is a measure that quantifies the extent of car weaving while driving. It has been shown to correlate well with blood alcohol concentrations, and traffic accident risk.

  1 h after intake of study medication (during a 30 min driving simulator test session)

• Standard deviation of lateral position (SDLP) on road

  SDLP is a measure that quantifies the extent of car weaving while driving. It has been shown to correlate well with blood alcohol concentrations, and traffic accident risk

  3,5 hrs after intake of study medication (during a 30 min driving simulator test session)

• Standard deviation of lateral position (SDLP) on road

  SDLP is a measure that quantifies the extent of car weaving while driving. It has been shown to correlate well with blood alcohol concentrations, and traffic accident risk

  6,5 hrs after intake of study medication (during a 30 min driving simulator test session)

Secondary Outcomes (7)

• Average speed

  1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)

• Standard deviation of speed

  1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)

• Frequency of brake pedal pressures

  1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)

• Frequency of accelerator pedal pressures

  1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)

• Steering wheel movement speed and reversal frequency

  1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)

Study Arms (4)

Zopiclone 5 mg

EXPERIMENTAL

Zopiclone 5 mg pill + placebo pill + placebo drink

Drug: Zopiclone; Drug: Placebo pill; Drug: Placebo drink

Zopiclone 10 mg

EXPERIMENTAL

2 x zopiclone 5 mg pills + placebo drink

Drug: Zopiclone; Drug: Placebo drink

Ethanol 0.8 g/L

ACTIVE COMPARATOR

2 x placebo pills + ethanol 50 g/70 kg

Drug: Ethanol; Drug: Placebo pill

Placebo

PLACEBO COMPARATOR

2 x placebo pills + placebo drink

Drug: Placebo pill; Drug: Placebo drink

Interventions

Zopiclone DRUG

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

Also known as: Imovane, Zopiklon, Zopiclon

Zopiclone 10 mg; Zopiclone 5 mg

Ethanol DRUG

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

Also known as: Alcohol, Ethyl alcohol

Ethanol 0.8 g/L

Placebo pill DRUG

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

Ethanol 0.8 g/L; Placebo; Zopiclone 5 mg

Placebo drink DRUG

Placebo drink, given orally as a single dose

Placebo; Zopiclone 10 mg; Zopiclone 5 mg

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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:
• Smoker? yes 0, no 1
• History of nausea and/or vomiting following surgery, dental treatment, injections or similar procedures? yes 0, no 1
• History of car sickness after 10 years of age? yes 0, no 1
• A score of two or more points excludes participation.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• SINTEF Health Research: collaborator
• Norwegian University of Science and Technology: collaborator
• Norwegian Institute of Public Health: collaborator

MeSH Terms

Interventions

zopiclone; Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Lars J Slørdal, MD, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 9, 2010
• Study Start: August 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 13, 2013

Record last verified: 2013-12