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| ID | Type | Description | Link |
|---|---|---|---|
| K23AA000222 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this study is to test how tolerable and effective lorazepam is when used to treat alcohol withdrawal in hospital patients at risk for alcohol withdrawal.
Studies show that symptom-triggered dosing is best for treatment of alcohol withdrawal in patients on chemical dependence units without other illness. On general medical hospital wards, withdrawal may be affected by comorbid medical illness. A clinical trial was undertaken to determine whether there is a difference between symptom-triggered (ST) and fixed-schedule (FS) dosing of lorazepam in patients hospitalized on general medical wards at a University medical center. Subjects were assessed by their nurses with the Revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale. Subjects in the ST arm received lorazepam doses based on CIWA-Ar score. Subjects in the FS arm received scheduled lorazepam with tapering over 4 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed-schedule treatment | Active Comparator | Fixed-schedule administration of lorazepam for alcohol withdrawal |
|
| Symptom-triggered treatment | Active Comparator | Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorazepam (drug) | Drug | Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Withdrawal Assessment Scores | Difference in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores between study arms | participants were followed for the duration of hospital stay, the median length of stay was 3 days |
| Total Dose of Lorazepam | Differences in total amount of lorazepam administered between protocol groups | participants were followed for the duration of hospital stay, the median length of stay was 3 days |
| Protocol Errors | Percentage of protocol errors between study arms, such as administration of an inappropriate lorazepam dose (inconsistent with CIWA-Ar score); excluded complications due to comorbid medical conditions. | participants were followed for the duration of hospital stay, the median length of stay was 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael F. Weaver, MD | Virginia Commonwealth University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16785215 | Result | Weaver MF, Hoffman HJ, Johnson RE, Mauck K. Alcohol withdrawal pharmacotherapy for inpatients with medical comorbidity. J Addict Dis. 2006;25(2):17-24. doi: 10.1300/j069v25n02_03. |
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| ID | Term |
|---|---|
| D008140 | Lorazepam |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Lorazepam | Drug | Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients |
|
|
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |