Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136617
Status:
COMPLETED
Last Update Posted:
2009-03-02
First Post:
2005-08-26
Brief Title:
Outpatient Treatment of Alcohol Withdrawal Syndrome
Sponsor:
Hvidovre University Hospital
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
Comparison of a Fixed-Schedule Therapy Versus a Symptom-Triggered Therapy for Alcohol Withdrawal Syndrome in Medical Out-Patients
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None