Treatment of Alcohol Withdrawal in Hospital Patients

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 4

Conditions: Alcohol Withdrawal Syndrome

Treatments: Drug: Lorazepam (drug); Drug: Lorazepam

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00249366

K23AA000222 (U.S. NIH Grant/Contract)

NIAAAWEA-K2300222-A

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 183 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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183 participants in 2 patient groups

Fixed-schedule treatment

Active Comparator group

Description:

Fixed-schedule administration of lorazepam for alcohol withdrawal

Treatment:

Drug: Lorazepam

Drug: Lorazepam (drug)

Symptom-triggered treatment

Active Comparator group

Description:

Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar)

Treatment:

Drug: Lorazepam

Drug: Lorazepam (drug)