Clinical trial NCT00146471: Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome
Official title: Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome [Sicherheit Und Wirksamkeit Von Levetiracetam (Keppra) für Die Behandlung Des stationären Alkoholentzugsyndroms]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Withdrawal Syndrome
Keywords: alcohol withdrawal
detoxification
Inpatients
alcohol dependence according to DSM-IV/ICD-10
withdrawal symptoms
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2005-09-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of levetiracetam for treating alcohol withdrawal syndrome (AWS) in inpatients (vs. placebo). The primary come-out parameter is the reduction of the total needed amount of diazepam for add-on treatment of acute alcohol withdrawal symptoms. The secondary come-out parameter are - safety criteria (AE) - reduction of alcohol withdrawal score over the days.


Eligibility criteria: Inclusion Criteria:

* Ages eligible for study: 18-65 years.
* 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:

* Current diagnosis of any other substance dependence syndrome other than alcohol dependence (excluding nicotine and caffeine dependence).
* 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

Primary outcomes:
measure: To evaluate the efficacy and safety of levetiracetam for treating alcohol withdrawal syndrome in inpatients. The primary come-out parameter is the reduction of the amount of diazepam for add-on treatment of acute alcohol withdrawal
timeFrame: during trial
Secondary outcomes:
measure: Secondary come-out parameters are - safety criteria (AE) - reduction of alcohol withdrawal score over the days
timeFrame: during trial
Other outcomes:
Locations:
city: Halle
country: Germany
facility: MLU Halle-Wittenberg
state: Sachen/Anhalt
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Klinik für Psychiatrie und Psychotherapie
city: Berlin
country: Germany
facility: Psychiatrische Klinik der Charité im St.-Hedwig Krankenhaus
city: Essen
country: Germany
facility: Klinik für Psychiatrie und Suchtmedizin, Kliniken Essen Mitte
city: Rhede
country: Germany
facility: Zentrum für Seelische Gesundheit
Study officials:
affiliation: Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
name: Martin Schaefer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.