HealthyPhase 1SEKO-ANCT03632408
Hangover and Residual Zopiclone Effect on Spatial Perception
A Phase 1 study testing Zopiclone and hangover in people with Healthy and Alcohol Drinking, run by Petri Vainio at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Alcohol Drinking
- What is being tested?
- Zopiclone and hangover
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2018to Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Teutori clinical trial facility
Turku, 20520
Petri J Vainio, MD, 0294504657, pejvai@utu.fi
Petri J Vainio, MD
About this study
Official title: The Effect of Alcohol Hangover and Night-time Zopiclone on Next-morning Spatial Perception in Healthy Young Volunteers
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.
- Conditions
- Healthy, Alcohol Drinking
- Being tested
- Zopiclone, hangover, Placebo oral capsule
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZopicloneDrug
Oral, single dose, 7.5 mg
hangoverBehavioural
as per subjects choice to consume alcohol
Placebo oral capsuleDrug
oral
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving error rate
Driving error rate
Measured: Day 1
Number of erroneous responses to peripheral visual stimuli during driving
Number of erroneous responses to peripheral visual stimuli during driving
Measured: Day 1
Secondary outcomes (2)
digit symbol substitution
digit symbol substitution test
Measured: Day 1
drug concentration
concentration of zopiclone in plasma
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Petri Vainio
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Sponsor-investigator, Petri Vainio, Turku University Hospital
- Investigators
- Petri J Vainio, MD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632408
- Sponsor's protocol ID
- T271
- Acronym
- SEKO-A
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alcohol Hangover and Night-time Zopiclone on Next-morning Spatial Perception in Healthy Young Volunteers
- ClinicalTrials.gov ID
- NCT03632408
- Acronym / sponsor ID
- SEKO-A / T271
- Conditions
- Healthy, Alcohol Drinking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Petri VainioOther government
- Collaborators
- University of Turku
- Study start
- Sep 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZopicloneOral, single dose, 7.5 mg | Drug | – |
| hangoveras per subjects choice to consume alcohol | Behavioural | – |
| Placebo oral capsuleoral | Drug | – |
Primary outcome
Driving error rate
Time frame: Day 1
Driving error rate
Number of erroneous responses to peripheral visual stimuli during driving
Time frame: Day 1
Number of erroneous responses to peripheral visual stimuli during driving
2 secondary outcomes
digit symbol substitution
Time frame: Day 1
drug concentration
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petri J Vainio, MD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zopiclone and hangover in people with Healthy and Alcohol Drinking, run by Petri Vainio at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petri J Vainio, MD (+358294504657, pejvai@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving error rate (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.