Outpatient Treatment of Alcohol Withdrawal Syndrome
Information source: Hvidovre University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholism; Alcohol Withdrawal
Intervention: chlordiazepoxide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hvidovre University Hospital Official(s) and/or principal investigator(s): Ulrik Becker, MD, Study Director, Affiliation: Hvidovre hospital, Denmark
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
Clinical Details
Official title: Comparison of a Fixed-Schedule Therapy Versus a Symptom-Triggered Therapy for Alcohol Withdrawal Syndrome in Medical Out-Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To shorten the AWS-period by determining the time to Short Alcohol Withdrawal Scale (SAWS)-score is below 12To 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: Compliance in alcohol treatmentTime to first relapse
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Alcohol Clinics at Hvidovre Hospital, Hvidovre 2650, Denmark
Additional Information
Starting date: August 2003
Last updated: February 27, 2009
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