Alcohol Drinking, Healthy
Conditions
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.
Interventions
DRUGZopiclone
Oral, single dose, 7.5 mg
BEHAVIORALhangover
as per subjects choice to consume alcohol
DRUGPlacebo oral capsule
oral
Sponsors
University of Turku
Petri Vainio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Driving error rate | Day 1 | Driving error rate |
| Number of erroneous responses to peripheral visual stimuli during driving | Day 1 | Number of erroneous responses to peripheral visual stimuli during driving |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| digit symbol substitution | Day 1 | digit symbol substitution test |
| drug concentration | Day 1 | concentration of zopiclone in plasma |
Countries
Finland
Contacts
Primary ContactPetri J Vainio, MD
Outcome results
None listed