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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT02372318
Eligibility Criteria:
Inclusion Criteria:
* severe alcohol use disorder according to DSM 5 and "heavy drinking": alcohol consumption \>=60g (men) and \>=40g (women) (minimum of 5 days / week)
* right-handedness
* normal or corrected to normal vision
* signed written informed consent
Exclusion Criteria:
valid at the time of MRI investigation:
* psychotropic medication within the last 14 days
* severe withdrawal symptoms (CIWA-Ar \> 4; Sullivan et al. 1989)
* intoxication (breath alcohol concentration \> 0.3 ‰)
* common exclusion criteria for MRI (e.g. metal, claustrophobia)
* positive drug screening (opioids, cannabinoids, benzodiazepines, barbiturates, cocaine, amphetamines)
* pregnancy
* contraindications to the prescription of nalmefene valid at inclusion:
* previous severe withdrawal / withdrawal complications
* previous inpatient detoxification treatment
* other Axis I psychiatric diagnoses than alcohol- or nicotine-dependence in the last 12 months
* neurological disorders, history of brain injury
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02372318
Study Brief:
Protocol Section:
NCT02372318