Hangover and Residual Zopiclone Effect on Spatial Perception | NCT03632408

Studies
Hangover and Residual Zopiclone Effect on Spatial Perception

NCT03632408

Sponsor

Petri Vainio

Status

Unknown status

Last Update Posted

Aug 15, 2018Actual

Enrollment

16Estimated

Phase

Phase 1

Conditions

Healthy
Alcohol Drinking

Interventions

Zopiclone
hangover
Placebo oral capsule

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2018Estimated

Primary Completion Date

May 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Aug 7, 2018

First Submission Date that Met QC Criteria

Aug 14, 2018

First Posted Date

Aug 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2018

Last Update Posted Date

Aug 15, 2018Actual

Name	Class
University of Turku	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Driving error rate	Driving error rate	Day 1
Number of erroneous responses to peripheral visual stimuli during driving	Number of erroneous responses to peripheral visual stimuli during driving	Day 1

Secondary Outcomes

Measure	Description	Time Frame
digit symbol substitution	digit symbol substitution test	Day 1
drug concentration	concentration of zopiclone in plasma	Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Petri J Vainio, MD	Contact	+358294504657		pejvai@utu.fi

Overall Officials

Name	Affiliation	Role
Petri J Vainio, MD	Turku University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Teutori clinical trial facility		Turku		20520	Finland

Condition Browse Module

MeSH Terms

ID	Term
D000428	Alcohol Drinking

Ancestor Terms

ID	Term
D004327	Drinking Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C515050	zopiclone
C503359	hang protein, Drosophila

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Triple

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

Who Masked

ParticipantInvestigatorOutcomes Assessor