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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT00811720
Eligibility Criteria:
Inclusion Criteria:
In- and outpatients who:
* had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - Text revision (DSM-IV-TR) criteria
* had had ≥6 HDDs in the 4 weeks preceding the Screening Visit
* had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit
Exclusion Criteria:
The patient:
* had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence
* had an antisocial personality disorder
* had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)
* had a history of delirium tremens or alcohol withdrawal seizures
* reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists
* reported current or recent treatment with antipsychotics or antidepressants
* was pregnant or breast-feeding
Other protocol-defined inclusion and exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00811720
Study Brief:
Protocol Section:
NCT00811720