NCT03632408

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

August 7, 2018

Last Update Submit

August 14, 2018

Conditions

HealthyAlcohol Drinking

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • digit symbol substitution

    Day 1

  • drug concentration

    Day 1

Interventions

ZopicloneDRUG

Oral, single dose, 7.5 mg

hangoverBEHAVIORAL

as per subjects choice to consume alcohol

Placebo oral capsuleDRUG

oral

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teutori clinical trial facility

Turku, 20520, Finland

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

zopiclonehang protein, Drosophila

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Petri J Vainio, MD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petri J Vainio, MD

CONTACT

+358294504657pejvai@utu.fi

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 15, 2018

Study Start

September 1, 2018

Primary Completion

May 1, 2019

Study Completion

December 1, 2019

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

FI(1)