Effekte von oraler Cortisol oder Propranolol-Gabe auf die Verarbeitung alkoholbezogener Schlüsselreize, den Schlaf und das Rückfallrisiko von alkoholabhängigen Patienten (Copro-Studie). - Copro-Studie

Conditions: alkohol dependence

Registration Number: EUCTR2009-014532-37-DE

Lead Sponsor: niversitätsklinikum Schleswig-Holstein

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

alcohol dependence,
abstention for 3 das minimum before entering the study,
male subject,
age in the rage 18 to 55 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

relevant psychiatric or organic comorbidities that might influence outcome and that might be negatively influenced by study medication e.g. depression, schizophrenia, obsessive comlusive disorder, anorexia, anxiety disorder, dementia, liver-cirrhosis, heart failure, epilepsy, dependence from other legal or illicit drugs.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Improvement of the success of cue-exposure by administration of hydrocortisone or propranolol, i.e. stronger attenuation of craving for alcohol;Secondary Objective: 1. improvement of abstination rates<br>2. testing and improving emotianal memory function<br>3. improvement of sleep profile<br>4. normalisation of disturbed cortisol reactivity to stress<br>5. testing and improving glucose tolerance and insulin resistance;Primary end point(s): ending cue-exposure after 10 sessions maximum, last assesment of sleep and memory in the sleep laboratory after end of cue-exposure treatment.

Secondary Outcome Measures