ntersuchung der Wirksamkeit und Sicherheit von Vareniclin in der Postakutbehandlung der Alkoholabhängigkeit - eine prospektive, bizentrische, doppelblinde, placebokontrollierte, randomisierte Phase II Studie

niversitätsmedizin der Johannes Gutenberg-Universität Mainz0 个研究点开始时间: 2009年10月26日最近更新: 2013年10月28日

适应症

试验速览

暂无简介。

•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

•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

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