Treatment of Alcohol Withdrawal in Hospital Patients
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ClinicalTrials.gov Identifier: NCT00249366 |
Recruitment Status :
Completed
First Posted : November 7, 2005
Last Update Posted : April 11, 2016
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Condition or disease | Intervention/treatment | Phase |
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Alcohol Withdrawal Syndrome | Drug: Lorazepam (drug) Drug: Lorazepam | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 183 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Acute Drug Withdrawal in a General Medical Setting |
Study Start Date : | April 2001 |
Actual Primary Completion Date : | May 2003 |
Actual Study Completion Date : | May 2003 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Fixed-schedule treatment
Fixed-schedule administration of lorazepam for alcohol withdrawal
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Drug: Lorazepam (drug)
Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
Other Name: Ativan Drug: Lorazepam Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
Other Name: Ativan |
Active Comparator: Symptom-triggered treatment
Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar)
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Drug: Lorazepam (drug)
Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
Other Name: Ativan Drug: Lorazepam Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients
Other Name: Ativan |
- Withdrawal Assessment Scores [ Time Frame: participants were followed for the duration of hospital stay, the median length of stay was 3 days ]Difference in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores between study arms
- Total Dose of Lorazepam [ Time Frame: participants were followed for the duration of hospital stay, the median length of stay was 3 days ]Differences in total amount of lorazepam administered between protocol groups
- Protocol Errors [ Time Frame: participants were followed for the duration of hospital stay, the median length of stay was 3 days ]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.

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Ages Eligible for Study: | 21 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Alcohol dependence (based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)
- Daily alcohol use for at least seven consecutive days with the last use no more than 72 hours prior to enrollment
- Patients on the General Internal Medicine service
Exclusion Criteria:
- Unable to give informed consent
- Chronically maintained on prescription sedative-hypnotics

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249366
United States, Virginia | |
Virginia Commonwealth University Medical Center | |
Richmond, Virginia, United States, 23219 |
Principal Investigator: | Michael F. Weaver, MD | Virginia Commonwealth University Medical Center |
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00249366 |
Other Study ID Numbers: |
NIAAAWEA-K2300222-A K23AA000222 ( U.S. NIH Grant/Contract ) |
First Posted: | November 7, 2005 Key Record Dates |
Last Update Posted: | April 11, 2016 |
Last Verified: | April 2016 |
Alcohol withdrawal Symptom-triggered therapy Fixed-schedule therapy CIWA-Ar Lorazepam (drug) |
Substance Withdrawal Syndrome Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Lorazepam Anticonvulsants Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Gastrointestinal Agents Hypnotics and Sedatives Central Nervous System Depressants Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |