Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03632408
Recruitment Status : Unknown
Verified August 2018 by Petri Vainio, Turku University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
University of Turku
Information provided by (Responsible Party):
Petri Vainio, Turku University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Alcohol Drinking Drug: Zopiclone Behavioral: hangover Drug: Placebo oral capsule Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Alcohol not masked Zopiclone and placebo capsulated, identical in weight and appearance Third party generated code only available to pharmacy and in case of emergency
Primary Purpose: Basic Science
Official Title: The Effect of Alcohol Hangover and Night-time Zopiclone on Next-morning Spatial Perception in Healthy Young Volunteers
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: Zopiclone
    Oral, single dose, 7.5 mg
  • Behavioral: hangover
    as per subjects choice to consume alcohol
  • Drug: Placebo oral capsule
    oral

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Driving error rate [ Time Frame: Day 1 ]
    Driving error rate

  2. Number of erroneous responses to peripheral visual stimuli during driving [ Time Frame: Day 1 ]
    Number of erroneous responses to peripheral visual stimuli during driving


Secondary Outcome Measures :
  1. digit symbol substitution [ Time Frame: Day 1 ]
    digit symbol substitution test

  2. drug concentration [ Time Frame: Day 1 ]
    concentration of zopiclone in plasma


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03632408


Contacts
Layout table for location contacts
Contact: Petri J Vainio, MD +358294504657 pejvai@utu.fi

Locations
Layout table for location information
Finland
Teutori clinical trial facility
Turku, Finland, 20520
Contact: Petri J Vainio, MD    0294504657    pejvai@utu.fi   
Principal Investigator: Petri J Vainio, MD         
Sponsors and Collaborators
Petri Vainio
University of Turku
Investigators
Layout table for investigator information
Principal Investigator: Petri J Vainio, MD Turku University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Petri Vainio, Assistant professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT03632408    
Other Study ID Numbers: T271
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alcohol Drinking
Drinking Behavior
Zopiclone
 Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs