SEKO-A: Hangover and Residual Zopiclone Effect on Spatial Perception

• Sponsor: Petri Vainio (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03632408
• Collaborator: University of Turku (Other)
• Enrollment: 16
• Location: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Alcohol Drinking	Drug: Zopiclone; Behavioral: hangover; Drug: Placebo oral capsule	Phase 1

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Sep 1, 2018
• Anticipated Primary Completion Date: May 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Outcome Measures

Primary Outcome Measures

1. Driving error rate [Day 1]

   Driving error rate

2. 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

1. digit symbol substitution [Day 1]

   digit symbol substitution test

2. drug concentration [Day 1]

   concentration of zopiclone in plasma

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Teutori clinical trial facility	Turku		Finland	20520

Sponsors and Collaborators

• Petri Vainio
• University of Turku

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Petri Vainio, Assistant professor, Turku University Hospital
• ClinicalTrials.gov Identifier: NCT03632408
• Other Study ID Numbers: T271
• First Posted: Aug 15, 2018
• Last Update Posted: Aug 15, 2018
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcohol Drinking; Zopiclone

Study Results

No Results Posted as of Aug 15, 2018