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NCT03632408 Clinical Trial

Hangover and Residual Zopiclone Effect on Spatial Perception

Healthy Clinical Trial

— SEKO-A  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03632408
Other study ID # T271
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date September 2018
Est. completion date December 2019

Study information
Verified date August 2018
Source Turku University Hospital
Contact Petri J Vainio, MD
Phone +358294504657
Email pejvai@utu.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 16
Est. completion date December 2019
Est. primary completion date May 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Finland Teutori clinical trial facility Turku

Sponsors (2)
Lead Sponsor Collaborator
Petri Vainio University of Turku

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Driving error rate Driving error rate Day 1
Primary Number of erroneous responses to peripheral visual stimuli during driving Number of erroneous responses to peripheral visual stimuli during driving Day 1
Secondary digit symbol substitution digit symbol substitution test Day 1
Secondary drug concentration concentration of zopiclone in plasma Day 1
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