Hangover and Residual Zopiclone Effect on Spatial Perception

NCT ID: NCT03632408

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Healthy Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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

Interventions

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Zopiclone

Oral, single dose, 7.5 mg

Intervention Type DRUG

hangover

as per subjects choice to consume alcohol

Intervention Type BEHAVIORAL

Placebo oral capsule

oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role collaborator

Petri Vainio

OTHER_GOV

Sponsor Role lead

Responsible Party

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Petri Vainio

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Petri J Vainio, MD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Teutori clinical trial facility

Turku, , Finland

Site Status

Countries

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Finland

Central Contacts

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Petri J Vainio, MD

Role: CONTACT

+358294504657

Facility Contacts

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Petri J Vainio, MD

Role: primary

0294504657

Other Identifiers

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T271

Identifier Type: -

Identifier Source: org_study_id

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