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| Tracking Information | |||||
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| First Received Date ICMJE | January 9, 2008 | ||||
| Last Updated Date | February 28, 2008 | ||||
| Start Date ICMJE | April 2003 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Duration of alcohol withdrawal syndrome (AWS) as defined by duration of time from admission to study, to measurement of Clinical Institute Withdrawal Assessment for Withdrqwal for Alcohol (CIWA-Ar)<5. [ Time Frame: Duration of time from admission to study, to measurement of CIWA-Ar ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00597701 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
" Area under the curve" how much lower the CIWA-Ar scores are for the cases, compared to the controls (until the primary endpoint is reached). This endpoint will utilize the average CIWA-Ar scores in each of the nine 8 hour periods of the 72 hours study. [ Time Frame: Average CIWA-Ar scores in each of the nine 8 hour periods of the 72 hours study ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treating Alcohol Withdrawal With Oral Baclofen | ||||
| Official Title ICMJE | Treating Alcohol Withdrawal With Oral Baclofen: a Randomized, Double Blind, Placebo Controlled Trial | ||||
| Brief Summary | The purpose of this study is determine if subjects with alcohol withdrawal who receive oral baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal symptoms than those who receive placebo plus standard benzodiazepine therapy.Subjects with alcohol withdrawal syndrome(AWS)who receive baclofen plus standard benzodiazepine therapy will experience fewer complications of AWS (as measured by use of additional sedatives, restraints, and/or ICU admissions) compared with subjects who receive placebo plus standard benzodiazepine therapy. |
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| Detailed Description | Alcohol use is ubiquitous in American society. 83% of americans have ever consumed alcohol, 51% have in the lst month. The average american consumes 2.18 gallons of ethanol yearly. Alcohol related morbidity and mortality are staggering problems in the USA. Symptoms of alcohol withdrawal occur because alcohol is a central nervous system depressant; abrupt withdrawal unmasks compensatory overactivity of certain parts of the nervous system, including sympathetic autonomic outflow. 5% of patients who undergo alcohol suffer from Delirium Tremors (DTs), a syndrome characterized by hallucinations, disorientation, tachycardia, hypertension, low grade fever, agitation, and diaphoresis. DTs typically begin between 48-96 hours after the last drink and last 1 to 5 days. DTs requires hospitalization and vigorous activity in an ICU setting. The most sucessful drug treatment for alcohol withdrawal has been found to be the benzodiazepines. Symptom triggered treatment was found to be as effective as a fixed dose treatment to result in less drug being used overall, with a trend toward shorter duration of withdrawal treatment. Baclofen is used orally for the treatment of spasticity resulting from multiple sclerosis, spinal cord injuries/diseases and intrathecally for spasticity related to cerebral palsy, spinal cord injury, and ALS. Its proposed benefit in alcohol withdrawal is that it may reduce voluntary alcohol intake, alcohol craving, and may suppress the intensity of alcohol withdrawal treatment. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Alcohol Withdrawal Delirium | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 90 | ||||
| Completion Date | February 2008 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00597701 | ||||
| Responsible Party | Julia pattison-Crisostomo, St. Mary's Duluth Clinic Health System | ||||
| Study ID Numbers ICMJE | 090403 | ||||
| Study Sponsor ICMJE | St. Mary's Duluth Clinic Health System | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | St. Mary's Duluth Clinic Health System | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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