Alcohol dependence MedDRA version: 14.1 Level: LLT Classification code 10001594 Term: Alcohol dependence syndrome System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Champix 0,5 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
CAS Number: 375815-87-5
Other descriptive name: VARENICLINE TARTRATE
Concentration unit: mg milligram(s)
Concentration
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyse the efficacy and safety of varenicline (Champix) versus placebo for relapse prevention in post-acute treatment (7-21 after last drink) in alcohol dependent patients. ;Secondary Objective: Investigation of drinking-quantity reducing properties of varenicline in a group of alcohol dependent patients, as measured by - Amount of alcoholic drinks per drinking day - Percentage of heavy drinking days (more than six standard drinks for a man and four standard drinks for a woman) Safety and tolerability of varenicline in post-acute treatment in alcohol dependent patients Investigation of alcohol craving with the OCDS and VAS Measurement the overall clinical impression (CGI) Measurement of quality of life (SF-12 questionnaire) Measurement of the frequency of smoking (number of cigarettes per day and percentage of abstinent days) Measurement of nicotine dependence severity (Fagerstrom Index for Nicotine Dependence - FTND) Measurement of severity of depression (Beck Depression Inventory - BDI) ;Primary end point(s): Percent of days abstinent from any alcohol (TLFB) during 12-weeks treatment;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: after 12 weeks of treatment | — |
Countries
Germany
Contacts
Public ContactTobias Wittig
Interdisziplinäres Zentrum Klinische Studien Mainz
Outcome results
None listed