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Outpatient Treatment of Alcohol Withdrawal Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00136617
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : March 2, 2009
Sponsor:
Information provided by:
Hvidovre University Hospital

Study Description
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Brief Summary:

The purpose of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients.

Objectives:

  • Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication
  • Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal syndrome
  • Outpatient treatment of alcohol withdrawal syndrome

Condition or disease Intervention/treatment Phase
Alcoholism Alcohol Withdrawal Drug: chlordiazepoxide Phase 3

Detailed Description:

The objective of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients.

Objectives:

  • Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication
  • Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal syndrome
  • Outpatient treatment of alcohol withdrawal syndrome

Patients and Methods:

This study is a prospective analysis of patients admitted to a medical outpatient clinic between August 25, 2003 and July 1, 2006, who experienced AWS. This study is conducted at Copenhagen Hospital Corporation in Copenhagen, Denmark. Patients were divided into two randomized groups: a symptom-triggered treatment versus a fixed-schedule treatment (known) with chlordiazepoxide. They were diagnosed with AWS according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition). They were diagnosed with alcohol dependence according to the ICD-10 (International Statistical Classification of Diseases and Health Related Problems).

Methods:

One hundred fifty consecutive patients who fulfill the inclusion criteria and not the exclusion criteria were offered to participate in the study, i.e. also patients who were detoxified at home or during admission. Patients were scored according to the DSM-IV for AWS and ICD-10 for alcohol dependence, and then they filled out a SAWS (Short Alcohol Withdrawal Scale). The score of 12 was the significant number of splitting patients to mild or moderate AWS. Randomization was done by the Research Unit. Patients were then treated with the traditionally fixed-schedule therapy (day 1, 200mg, chlordiazepoxide decreasing with 25 mg a day) or the new symptom-triggered therapy (up to 300 mg, chlordiazepoxide a day). For up until 10 days, patients monitored themselves for all ten days according to the SAWS. They were asked about mental conditions day 1-14 and every third month using the World Health Organization (WHO)-5 schedule.

On day 10 they filled out an adverse reactions questionnaire on chlordiazepoxide and a DTSQ (Diabetes Treatment Satisfaction Questionnaire) and an ASI (Addiction Severity Index) every third month.

Relapses and intake of any alcohol during a year are monitored.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of a Fixed-Schedule Therapy Versus a Symptom-Triggered Therapy for Alcohol Withdrawal Syndrome in Medical Out-Patients
Study Start Date : August 2003
Actual Primary Completion Date : July 2006
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To shorten the AWS-period by determining the time to Short Alcohol Withdrawal Scale (SAWS)-score is below 12
  2. To give the most safe treatment to the patients and reduce the risk of further development of alcohol withdrawal syndrome with seizures and delirium tremens
  3. AWS score day 1, 2, 3, etc.
  4. Use of medication
  5. Patient satisfaction
  6. Wellbeing

Secondary Outcome Measures :
  1. Compliance in alcohol treatment
  2. Time to first relapse

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients above the age of 18
  • Fulfilled informed consent
  • Abstained from alcohol within the last 72 hours.
  • Agree on both treatment regimens.
  • Abstinence during 10 days (monitoring and medication period), i.e. treatment with disulfiram or oral alcometer test on every attendance (Lion Alcometer S-D2).

Exclusion Criteria:

  • Oral alcoholmeter test > 0.1.
  • Treatment of AWS within the last week
  • 3 earlier attempts at outpatient detoxification within the last 2 months without success.
  • Allergy or adverse reactions to chlordiazepoxide
  • Treatment with medication in interaction with chlordiazepoxide
  • Psychiatric comorbidity within the last year, dependence on other drugs except nicotine dependence
  • Medically severe comorbidity, especially severe liver insufficiency
  • Severe cardiovascular diseases, NIDDM and IDDM.
  • A history within the last year of seizures and delirium tremens.
  • Patients should be cooperative in terms of cooperation and understanding of the Danish language.
  • Females of fertile age without safe contraception, (i.e. IUD, hormone tablets or sterilisation) also pregnant or breastfeeding women were excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136617


Locations
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Denmark
Alcohol Clinics at Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Study Director: Ulrik Becker, MD Hvidovre University Hospital
More Information
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ClinicalTrials.gov Identifier: NCT00136617    
Other Study ID Numbers: AWS
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: March 2, 2009
Last Verified: February 2009
Keywords provided by Hvidovre University Hospital:
Short Alcohol Withdrawal Scale
Documentation
Additional relevant MeSH terms:
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Alcoholism
Substance Withdrawal Syndrome
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Chlordiazepoxide
Adjuvants, Anesthesia
Hypnotics and Sedatives
 Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action