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Sponsored by: |
Hvidovre University Hospital |
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Information provided by: | Hvidovre University Hospital |
ClinicalTrials.gov Identifier: | NCT00136617 |
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:
Condition | Intervention | Phase |
---|---|---|
Alcoholism Alcohol Withdrawal |
Drug: chlordiazepoxide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | Comparison of a Fixed-Schedule Therapy Versus a Symptom-Triggered Therapy for Alcohol Withdrawal Syndrome in Medical Out-Patients |
Enrollment: | 165 |
Study Start Date: | August 2003 |
Study Completion Date: | September 2008 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | AWS |
Study First Received: | August 26, 2005 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00136617 History of Changes |
Health Authority: | Denmark: National Board of Health |
Short Alcohol Withdrawal Scale Documentation |
Neurotransmitter Agents Substance Withdrawal Syndrome Tranquilizing Agents Adjuvants, Immunologic Psychotropic Drugs Anesthetics Disorders of Environmental Origin Central Nervous System Depressants |
Mental Disorders Alcoholism Hypnotics and Sedatives Substance-Related Disorders Alcohol-Related Disorders Anti-Anxiety Agents Chlordiazepoxide Ethanol |
Neurotransmitter Agents Tranquilizing Agents Substance Withdrawal Syndrome Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Central Nervous System Depressants Pharmacologic Actions Adjuvants, Anesthesia |
Mental Disorders Therapeutic Uses Alcoholism Hypnotics and Sedatives Substance-Related Disorders GABA Agents Anti-Anxiety Agents Alcohol-Related Disorders Chlordiazepoxide Central Nervous System Agents |