Outpatient Treatment of Alcohol Withdrawal Syndrome

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00136617
First received: August 26, 2005
Last updated: February 27, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Alcoholism
Alcohol Withdrawal
Drug: chlordiazepoxide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Compliance in alcohol treatment
  • Time to first relapse

Enrollment: 165
Study Start Date: August 2003
Study Completion Date: September 2008
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136617

Locations
Denmark
Alcohol Clinics at Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Study Director: Ulrik Becker, MD Hvidovre Hospital, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00136617     History of Changes
Other Study ID Numbers: AWS
Study First Received: August 26, 2005
Last Updated: February 27, 2009
Health Authority: Denmark: National Board of Health

Keywords provided by Hvidovre University Hospital:
Short Alcohol Withdrawal Scale
Documentation

Additional relevant MeSH terms:
Alcoholism
Substance Withdrawal Syndrome
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Chlordiazepoxide
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Adjuvants, Anesthesia
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014