Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02113618
Eligibility Criteria:
Inclusion Criteria:
* Male or a non-pregnant/non-nursing female
* Minimum of nine years of education
* AUDIT \> 11 (performed at tele-screening) and scores 3 or 4 points on first AUDIT question (drinks 2-3 times per week or more)
* Fulfils the DSM-5 criteria for Alcohol Use Disorder
* Minimum 3 and maximum 14 alcohol-free days before day of inclusion (including day of inclusion)
* Access to a home computer with internet connection during the study
* Be willing to give informed consent and comply with study procedures
Exclusion Criteria:
* Fulfils current DSM IV diagnosis of any other substance dependence disorder (except nicotine)
* Fulfils current DSM IV diagnosis of the any major psychiatric disorder such as schizophrenia, bipolar disorder or severe major depression
* Suicidal ideation at screening
* Homelessness
* Acute withdrawal in need of pharmacological treatment (Ciwa score \> 14) on day of inclusion
* Previous withdrawal-induced delirium tremens or seizures
* Regular intake of psychotropic medication (including acamprosate, naltrexone, disulfiram, antipsychotics, mood stabilizers, antiepileptic medication, benzodiazepines) the last 6 months before screening (exceptions include SSRI against anxiety or depressive illness currently in remission + temporary use of benzodiazepiner against withdrawal and non addictive substances e.g. prometazin (Lergigan®), propiomazin (Propavan®), alimemazin (Theralen®) or hydroxizin (Atarax®)
* Presence of non-stabilized severe medical illness e.g. liver cirrhosis, untreated severe essential hypertension (\>160/100 mm Hg), uncontrolled diabetes mellitus, ischaemic heart disease, epilepsy
* History of stroke, intracranial hemorrhage or severe head trauma/traumatic brain injury
* Impaired sense of smell
* Use of any illegal drugs for the last 30 days
* Traces of alcohol as measured by breathalyzer on the Inclusion or Test day
* Traces of any other psychoactive substance (e.g. central stimulant amines, THC, benzodiazepines, opiates, cocaine) in urine sample on inclusion day or during the course of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02113618
Study Brief:
Protocol Section:
NCT02113618