Alcoholism Clinical Trial
Official title:
Comparison of a Fixed-Schedule Therapy Versus a Symptom-Triggered Therapy for Alcohol Withdrawal Syndrome in Medical Out-Patients
Verified date | February 2009 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: National Board of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 165 |
Est. completion date | September 2008 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Alcohol Clinics at Hvidovre Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To shorten the AWS-period by determining the time to Short Alcohol Withdrawal Scale (SAWS)-score is below 12 | No | ||
Primary | 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 | |||
Primary | AWS score day 1, 2, 3, etc. | |||
Primary | Use of medication | |||
Primary | Patient satisfaction | |||
Primary | Wellbeing | |||
Secondary | Compliance in alcohol treatment | |||
Secondary | Time to first relapse |
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