Hangover and Residual Zopiclone Effect on Spatial Perception

Petri Vainio16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy Alcohol Drinking

Interventions

ZopicloneDRUG

Oral, single dose, 7.5 mg

hangoverBEHAVIORAL

as per subjects choice to consume alcohol

Placebo oral capsuleDRUG

oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Teutori clinical trial facility

Turku, Finland

Outcomes

Primary Outcomes

Driving error rate

Time frame: Day 1

Number of erroneous responses to peripheral visual stimuli during driving

Time frame: Day 1

Secondary Outcomes

digit symbol substitution

digit symbol substitution test

Time frame: Day 1

drug concentration

concentration of zopiclone in plasma

Time frame: Day 1

Central Contacts

Petri J Vainio, MD

CONTACT

+358294504657 pejvai@utu.fi

Data from ClinicalTrials.gov

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