Hangover and Residual Zopiclone Effect on Spatial Perception (SEKO-A)

August 14, 2018 updated by: Petri Vainio

The Effect of Alcohol Hangover and Night-time Zopiclone on Next-morning Spatial Perception in Healthy Young Volunteers

Hangover after recreational alcohol use, residual effect of zopiclone and placebo compared in terms of spatial perception, psychomotor tests and simulated driving ability. Three recording visits plus screening included.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Petri J Vainio, MD
  • Phone Number: +358294504657
  • Email: pejvai@utu.fi

Study Locations

  • Finland
      • Turku, Finland, 20520
        • Teutori clinical trial facility
        • Contact:
          • Petri J Vainio, MD
          • Phone Number: 0294504657
          • Email: pejvai@utu.fi
        • Principal Investigator:
          • Petri J Vainio, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • weight >45 kg
  • likely to experience and predict alcohol hangover within the next five weeks
  • no childbearing potential of negative pregnancy test at screening
  • a valid driving license

Exclusion Criteria:

  • breastfeeding
  • infection with HCV, HBV or HIV
  • a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
  • suspected or current drug or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Driving error rate
Time Frame: Day 1
Driving error rate
Day 1
Number of erroneous responses to peripheral visual stimuli during driving
Time Frame: Day 1
Number of erroneous responses to peripheral visual stimuli during driving
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
digit symbol substitution
Time Frame: Day 1
digit symbol substitution test
Day 1
drug concentration
Time Frame: Day 1
concentration of zopiclone in plasma
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Petri Vainio

Collaborators

University of Turku

Investigators

  • Principal Investigator: Petri J Vainio, MD, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T271

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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