Treatment of Alcohol Withdrawal in Hospital Patients

NCT ID: NCT00249366

Last Updated: 2016-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2003-05-31

Brief Summary

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.

Detailed 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.

Conditions

Alcohol Withdrawal Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fixed-schedule treatment

Fixed-schedule administration of lorazepam for alcohol withdrawal

Group Type: ACTIVE_COMPARATOR

Lorazepam (drug)

Intervention Type: DRUG

Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients

Lorazepam

Intervention Type: DRUG

Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients

Symptom-triggered treatment

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

Group Type: ACTIVE_COMPARATOR

Lorazepam (drug)

Intervention Type: DRUG

Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients

Lorazepam

Intervention Type: DRUG

Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients

Interventions

Lorazepam (drug)

Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients

Intervention Type: DRUG

Lorazepam

Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients

Intervention Type: DRUG

Other Intervention Names

Ativan; Ativan

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael F. Weaver, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University Medical Center

Locations

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 16785215 (View on PubMed)

Other Identifiers

K23AA000222

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAAWEA-K2300222-A

Identifier Type: -

Identifier Source: org_study_id