Outpatient Treatment of Alcohol Withdrawal Syndrome

NCT00136617 | Completed Phase 3 DMC

• 1 other identifier: AWS
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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

Conditions

Alcoholism; Alcohol Withdrawal

Keywords

Short Alcohol Withdrawal Scale; Documentation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Compliance in alcohol treatment

• Time to first relapse

Interventions

chlordiazepoxide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Oral alcoholmeter test \> 0.1.
• Treatment of AWS within the last week
• 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.

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Alcohol Clinics at Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Chlordiazepoxide

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ulrik Becker, MD

  Hvidovre University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Study Start: August 1, 2003
• Primary Completion: July 1, 2006
• Study Completion: September 1, 2008
• Last Updated: March 2, 2009

Record last verified: 2009-02

Locations

DK (1)