Comparison of a fixed-schedule therapy versus a symptom-triggered therapy for Alcohol Withdrawal Syndrome in Medical out-patients.

Objectives

1. Self-governance in monitoring AWS(Alcohol Withdrawal Syndrome)symptoms and medication
2. Clinical controlled trial on two regimens for medical treatment of the Alcohol Withdrawal Syndrome
3. Outpatient-treatment of the Alcohol Withdrawal Syndrome

Condition	Intervention	Phase
Alcoholism Alcohol Withdrawal	Drug: chlordiazepoxide	Phase III

Further Study Details: 

Primary Outcomes: To shorten the AWS-period by determine the time to SAWS-score is zero.; To give the most safe treatment to the patients and reduce the risc of further development of the Alcohol Withdrawal Syndrome with seizures and Delirium Tremens.; AWS score day 1, 2, 3 etc.; Use of Medication; Patient satisfaction; Wellbeing
Secondary Outcomes: Compliance in Alcohol treatment·; Time to first relapse
Expected Total Enrollment:  150

Comparison of a fixed-schedule therapy versus a symptom-triggered therapy for Alcohol Withdrawal Syndrome in Medical out-patients.

Objectives

1. Self-governance in monitoring AWS(Alcohol Withdrawal Syndrome)symptoms and medication
2. Clinical controlled trial on two regimens for medical treatment of the Alcohol Withdrawal Syndrome
3. Outpatient-treatment of the 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 May 1, 2005, who experienced AWS. This study is conducted at Copenhagen Hospitals Corporation Copenhagen, Denmark. Patients were divided into two randomized groups- a symptom-triggered treatment versus a fixed-schedule treatment (known)with Choldiazepoxid. They were diagnosed for AWS according to DSM IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition).They were diagnosed for Alcohol dependence according to the ICD 10(International Statistical Classifikation of Diseases and Health Related Problems).

Inclusion criteria were. Patients above the age of 18 who forfilled 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 Alcometertest on every attendance((Lion Alcometer S-D2).

Exclusion criteria was: Oral Alcoholmeter test> 0.1. Treatment of AWS within the last week, 3 earlier attempts on out-patient detoxification within the last 2 months without success. Allergy or adverse reactions to Chlordiazepoxid, Treatment with medication in interaction with Chlordiazepoxid, Psychiatric Comorbidity within the last year, Dependence of other drugs except Nicotine dependence, Medical severe comorbidity especially severe Liver insufficiency, severe Cardiovascular Diseases, NIDDM and IDDM. And of course history within the last year of seizures and Delirium Tremens. Patients should be cooperable in terms of cooperation and understanding of the Danish language. Females in fertilage without saf Anticonception, (i.e. IUD. Hormone tablets or sterilisation) also Pregnant or breastfeeding women were excluded.

Methods 150 consecutive Patients who forfill the inclusion criteria and not th 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 ICD10 for Alcohol dependence,and then they filled out a SAWS (Short Alcohol Withdrawal Scale). The score 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 Chlordiazepoxid decreasing with 25 mg a day) or the new symptom-triggered therapy( Up to 300 mg Chlordiazepoxid a day). For up till 10 days. Patients monitored them selves for all ten days according to the SAWS. They were asked about mental condition day 1-14 and every third month using the WHO-5 schedule.

Day 10 they filled out a adverse reactions questionnaire on Chlordiazepoxid. and a DTSQ( Diabetes Treatment Satisfaction Questionnaire) and a ASI (Addiction Severity Index) every third month.

Relapses and intake of any alcohol during a year are monitored.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients above the age of 18
• Forfilled 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 Alcometertest on every attendance((Lion Alcometer S-D2).

Exclusion Criteria:

• Oral Alcoholmeter test> 0.1.
• Treatment of AWS within the last week
• 3 earlier attempts on out-patient detoxification within the last 2 months without success.
• Allergy or adverse reactions to Chlordiazepoxid
• Treatment with medication in interaction with Chlordiazepoxid
• Psychiatric Comorbidity within the last year, Dependence of other drugs except Nicotine dependence
• Medical 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 cooperable in terms of cooperation and understanding of the Danish language. Females in fertilage without saf Anticonception, (i.e. IUD. Hormone tablets or sterilisation) also Pregnant or breastfeeding women were excluded.

Please refer to this study by ClinicalTrials.gov identifier  NCT00136617

ulrik becker, MD      +45 3632 2289    ulrik.becker@hh.hosp.dk
bjarne elholm, RN      +45 3632 2827    bjarne.elholm@hh.hosp.dk

Denmark
      Alcohol Clinics at Hvidovre Hospital, Hvidovre,  2650,  Denmark; Recruiting

Study chairs or principal investigators

ulrik becker, MD,  Study Director,  Hvidovre Hospital, Denmark   

Study ID Numbers:  AWS
Last Updated:  August 26, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00136617
Health Authority: Denmark: National Board of Health
ClinicalTrials.gov processed this record on 2005-08-30