Postaktutbehandlung der Alkoholabhängigkeit

• Conditions: Alcohol dependence; MedDRA version: 14.1Level: LLTClassification code 10001594Term: Alcohol dependence syndromeSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2009-015537-67-DE
• Lead Sponsor: niversitätsmedizin der Johannes Gutenberg-Universität Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-26
• Last Update Posted: 28 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Alcohol dependent as defined by the criteria of Diagnostic and Statistical Manual of mental disorders (DSM IV)
Male and female in- or outpatients
Current smoker
Aged 18 to 65 years
Last consumption of alcohol 7-21 days before randomisation
Detoxified and free of withdrawal symptoms at randomisation
Sufficient knowledge of German language
Able to follow verbal and written instructions
Able to provide written informed consent
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Delirium after current withdrawal, alcohol-induced dementia, Wernicke-Korsakoff syndrome
Severe renal insufficiency
Severe liver insufficiency
Involutary Detoxification
Female patients pregnant, breast feeding or fo child bearing age and not protected by medically acceptable contraception
Patients with clinically relevant concomitant psychiatric discorders (including a major depressive episode, psychotic discorders, antisocial personality disorder according to DSM IV in medial history)
Patients with an addiction or substance abuse of other addiction-inducing substances (except nicotine or cannabis) within the last 24 months before inclusion in the trial
Patient having a current suicide risk with a score > 6 at the suicidality item C of the M.I.N.I. international neuropsychiatric interview (MINI)
Patients with any clinically significant acute or chronic progressive neurological, gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, dermatological or respiratory disease
Patients with a current relevant depression (Hamilton Rating Scale for Depression (German version) values = 9 or Beck Depression Inventory (German version) values = 12)
Patients with a history of cancer within the last five years
Patients with a history of stroke or myocardial infarction within the last 6 months before screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified