NCT00523185

Brief Summary

The purpose of this study is to compare the efficacy of two commonly used medications in the treatment of alcohol withdrawal, diazepam and lorazepam.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2003

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
Last Updated

August 31, 2007

Status Verified

August 1, 2007

First QC Date

August 29, 2007

Last Update Submit

August 29, 2007

Conditions

Alcohol Withdrawal

Keywords

alcohol withdrawallorazepamdiazepam

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measures include serial measures of vital signs and scores on the Clinical Institute Withdrawal Assessment for Alcohol-Revised scale (CIWA-Ar), a widely used scale that monitors alcohol withdrawal symptoms.

    one to two weeks

Secondary Outcomes (1)

  • Secondary outcome measures include total benzodiazepine use.

    one to two weeks

Study Arms (2)

2

ACTIVE COMPARATOR
Drug: Diazepam

1

ACTIVE COMPARATOR
Drug: Lorazepam

Interventions

LorazepamDRUG

Lorazepam 1 to 2 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.

Also known as: Ativan
1
DiazepamDRUG

Diazepam 20 mg by mouth every two hours x 3 doses, or for parenteral treatment, diazepam 10 mg intravenously every one hour x 6 doses. Give additional diazepam 10 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.

Also known as: Valium
2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of alcohol withdrawal
  • History of alcohol use within 24 hours
  • Ability to consent to participate in the study

You may not qualify if:

  • Unwillingness to participate in the study
  • Active abuse of other CNS depressants
  • Acute intoxication with a CNS activating agent
  • Severe hepatic dysfunction
  • Pregnancy
  • History of dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Palo Alto Veterans Affairs Hospital System

Palo Alto, California, 94304, United States

Location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Maldonado JR, Nguyen LH, Schader EM, Brooks JO 3rd. Benzodiazepine loading versus symptom-triggered treatment of alcohol withdrawal: a prospective, randomized clinical trial. Gen Hosp Psychiatry. 2012 Nov-Dec;34(6):611-7. doi: 10.1016/j.genhosppsych.2012.06.016. Epub 2012 Aug 13.

    PMID: 22898443DERIVED

MeSH Terms

Interventions

LorazepamDiazepam

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jose R Maldonado, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 31, 2007

Study Start

May 1, 2003

Study Completion

November 1, 2004

Last Updated

August 31, 2007

Record last verified: 2007-08

Locations

US(2)