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Outpatient Treatment of Alcohol Withdrawal Syndrome

Primary Purpose

Alcoholism, Alcohol Withdrawal

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
chlordiazepoxide
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Short Alcohol Withdrawal Scale, Documentation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcohol Clinics at Hvidovre Hospital

Outcomes

Primary Outcome Measures

To shorten the AWS-period by determining the time to Short Alcohol Withdrawal Scale (SAWS)-score is below 12
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

Full Information

First Posted
August 26, 2005
Last Updated
February 27, 2009
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00136617
Brief Title
Outpatient Treatment of Alcohol Withdrawal Syndrome
Official Title
Comparison of a Fixed-Schedule Therapy Versus a Symptom-Triggered Therapy for Alcohol Withdrawal Syndrome in Medical Out-Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Withdrawal
Keywords
Short Alcohol Withdrawal Scale, Documentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
chlordiazepoxide
Primary Outcome Measure Information:
Title
To shorten the AWS-period by determining the time to Short Alcohol Withdrawal Scale (SAWS)-score is below 12
Title
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
Title
AWS score day 1, 2, 3, etc.
Title
Use of medication
Title
Patient satisfaction
Title
Wellbeing
Secondary Outcome Measure Information:
Title
Compliance in alcohol treatment
Title
Time to first relapse

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Becker, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Alcohol Clinics at Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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Outpatient Treatment of Alcohol Withdrawal Syndrome

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