Hangover and Residual Zopiclone Effect on Spatial Perception

Phase 1

• Conditions: Healthy; Alcohol Drinking

• Registration Number: NCT03632408
• Lead Sponsor: Petri Vainio

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-14
• Last Update Submitted: 2018-08-14
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15
• Study Start: 2018-09
• Primary Completion: 2019-05
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Driving error rate	Day 1	Driving error rate
Number of erroneous responses to peripheral visual stimuli during driving	Day 1	Number of erroneous responses to peripheral visual stimuli during driving

Secondary Outcome Measures

Name	Time	Method
drug concentration	Day 1	concentration of zopiclone in plasma
digit symbol substitution	Day 1	digit symbol substitution test

Trial Locations

Locations (1)

Teutori clinical trial facility; 🇫🇮 Turku, Finland