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

Primary Purpose

Healthy, Alcohol Drinking

Status
Unknown status
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
Zopiclone
hangover
Placebo oral capsule
Sponsored by
Petri Vainio
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Teutori clinical trial facility

Outcomes

Primary Outcome Measures

Driving error rate
Driving error rate
Number of erroneous responses to peripheral visual stimuli during driving
Number of erroneous responses to peripheral visual stimuli during driving

Secondary Outcome Measures

digit symbol substitution
digit symbol substitution test
drug concentration
concentration of zopiclone in plasma

Full Information

First Posted
August 7, 2018
Last Updated
August 14, 2018
Sponsor
Petri Vainio
Collaborators
University of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT03632408
Brief Title
Hangover and Residual Zopiclone Effect on Spatial Perception
Acronym
SEKO-A
Official Title
The Effect of Alcohol Hangover and Night-time Zopiclone on Next-morning Spatial Perception in Healthy Young Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Petri Vainio
Collaborators
University of Turku

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Alcohol Drinking

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zopiclone
Intervention Description
Oral, single dose, 7.5 mg
Intervention Type
Behavioral
Intervention Name(s)
hangover
Intervention Description
as per subjects choice to consume alcohol
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
oral
Primary Outcome Measure Information:
Title
Driving error rate
Description
Driving error rate
Time Frame
Day 1
Title
Number of erroneous responses to peripheral visual stimuli during driving
Description
Number of erroneous responses to peripheral visual stimuli during driving
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
digit symbol substitution
Description
digit symbol substitution test
Time Frame
Day 1
Title
drug concentration
Description
concentration of zopiclone in plasma
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petri J Vainio, MD
Phone
+358294504657
Email
pejvai@utu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petri J Vainio, MD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teutori clinical trial facility
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petri J Vainio, MD
Phone
0294504657
Email
pejvai@utu.fi
First Name & Middle Initial & Last Name & Degree
Petri J Vainio, MD

12. IPD Sharing Statement

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Hangover and Residual Zopiclone Effect on Spatial Perception

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