Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome
NCT ID: NCT00146471
Last Updated: 2009-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2006-01-31
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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2
Levetiracetam
1500-2000 mg daily add-on or Placebo Diazepam as needed
1: Diazepam plus Placebo
Placebo
1500-2000 mg daily add-on or Placebo Diazepam as needed
Interventions
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Levetiracetam
1500-2000 mg daily add-on or Placebo Diazepam as needed
Placebo
1500-2000 mg daily add-on or Placebo Diazepam as needed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meets criteria for alcohol dependence according to DSM-IV/ICD-10
* Known withdrawal symptoms in the past in case of discontinuation of alcohol consumption
* Hospital admission for alcohol detoxification
* Able to provide a written informed consent.
* Able to follow verbal and written instructions (incl. a sufficient knowledge of German language).
* Must be medically acceptable for study treatment. No past or present physical disorder that is likely to deteriorate during participation. No ECG abnormality which would likely worsen during participation and no clinical laboratory abnormality that would also suggest deterioration during treatment.
* Have a negative urine drug screen for benzodiazepines or heroine or methadone
Exclusion Criteria
* History of idiopathic epilepsy.
* Patient with any current clinically significant psychiatric disorder (acute suiciality) or developmental disorder (including organic mental disorder), like psychotic disorders.
* Patients with the following complications of alcoholism (lifetime): acute delirium tremens, hallucinatory alcoholic state, Korsakoff's syndrome, Wernicke encephalopathy, decomposed liver cirrhosis (Child B, C), suspected cirrhosis with the following clinical symptoms detected at clinical exam: signs of portal hypertension and signs of hepato-cellular failure, thrombocytopenia.
* Subjects with known sensitivity of previous adverse reaction to levetiracetam
* Contra-indication (hypersensitivity to levetiracetam or pyrrolidone derivatives) or known non-response to levetiracetam.
* History of severe GI disease which might render absorption of the medication difficult or produce medical instability of the patient which would include active peptic ulcer disease, ulcerative colitis, regional colitis, or evidence by history or physical exam of GI bleeding.
* Patients with any clinically significant acute or chronic progressive neurological, gastrointestinal, cardiovascular, hepatic, renal, haematological, endocrine, dermatological or respiratory disease, such as diabetes, severe infection, acute alcoholic hepatitis, or any other medical condition with significant worsening of the clinical situation of the patient that might interfere with the evaluation of study medication.
* Female patients pregnant, breast-feeding or of child bearing age and not protected by effective contraceptive such as implants, injectables, combined oral contraceptives, some IUDS, sexual abstinence, sterilization or vasectomized partner.
* Actually continuous use of pharmacological agents that are known to lower the seizure threshold or augment or decrease the alcohol withdrawal syndrome.
* Subjects with known sensitivity of previous adverse reaction to diazepam or clonidine
* Contra-indication or known non-response to diazepam or clonidine
18 Years
65 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Charite University, Berlin, Germany
Principal Investigators
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Martin Schaefer, MD
Role: PRINCIPAL_INVESTIGATOR
Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
Locations
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MLU Halle-Wittenberg
Halle, Sachen/Anhalt, Germany
Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Klinik für Psychiatrie und Psychotherapie
Berlin, State of Berlin, Germany
Psychiatrische Klinik der Charité im St.-Hedwig Krankenhaus
Berlin, State of Berlin, Germany
Klinik für Psychiatrie und Suchtmedizin, Kliniken Essen Mitte
Essen, , Germany
Zentrum für Seelische Gesundheit
Rhede, , Germany
Countries
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References
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Krebs M, Leopold K, Richter C, Kienast T, Hinzpeter A, Heinz A, Schaefer M. Levetiracetam for the treatment of alcohol withdrawal syndrome: an open-label pilot trial. J Clin Psychopharmacol. 2006 Jun;26(3):347-9. doi: 10.1097/01.jcp.0000219926.49799.89. No abstract available.
Richter C, Hinzpeter A, Schmidt F, Kienast T, Preuss UW, Plenge T, Heinz A, Schaefer M. Levetiracetam for the treatment of alcohol withdrawal syndrome: a multicenter, prospective, randomized, placebo-controlled trial. J Clin Psychopharmacol. 2010 Dec;30(6):720-5. doi: 10.1097/jcp.0b013e3181faf53e.
Other Identifiers
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Kep-F10.3.01
Identifier Type: -
Identifier Source: org_study_id