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Outpatient Treatment of Alcohol Withdrawal Syndrome
This study has been completed.
Study NCT00136617   Information provided by Hvidovre University Hospital
First Received: August 26, 2005   Last Updated: February 27, 2009   History of Changes

August 26, 2005
February 27, 2009
August 2003
July 2006   (final data collection date for primary outcome measure)
  • To shorten the AWS-period by determining the time to Short Alcohol Withdrawal Scale (SAWS)-score is below 12 [ Designated as safety issue: No ]
  • 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
  • AWS score day 1, 2, 3, etc.
  • Use of medication
  • Patient satisfaction
  • Wellbeing
  • To shorten the AWS-period by determine the time to SAWS-score is zero.
  • To give the most safe treatment to the patients and reduce the risc of further development of the Alcohol Withdrawal Syndrome with seizures and Delirium Tremens.
  • AWS score day 1, 2, 3 etc.
  • Use of medication
  • Patient satisfaction
  • Wellbeing
Complete list of historical versions of study NCT00136617 on ClinicalTrials.gov Archive Site
  • Compliance in alcohol treatment
  • Time to first relapse
  • Compliance in Alcohol treatment·
  • Time to first relapse
 
Outpatient Treatment of Alcohol Withdrawal Syndrome
Comparison of a Fixed-Schedule Therapy Versus a Symptom-Triggered Therapy for Alcohol Withdrawal Syndrome in Medical Out-Patients

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

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.

Phase III
Interventional
Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
  • Alcoholism
  • Alcohol Withdrawal
Drug: chlordiazepoxide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
165
September 2008
July 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00136617
 
AWS
Hvidovre University Hospital
 
Study Director: Ulrik Becker, MD Hvidovre Hospital, Denmark
Hvidovre University Hospital
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP