NCT00249366

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2001

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

April 1, 2001

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
Last Updated

April 11, 2016

Status Verified

April 1, 2016

Enrollment Period

2.1 years

First QC Date

November 3, 2005

Last Update Submit

April 8, 2016

Conditions

Alcohol Withdrawal Syndrome

Keywords

Alcohol withdrawalSymptom-triggered therapyFixed-schedule therapyCIWA-ArLorazepam (drug)

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Fixed-schedule treatment

ACTIVE COMPARATOR

Fixed-schedule administration of lorazepam for alcohol withdrawal

Drug: Lorazepam (drug)Drug: Lorazepam

Symptom-triggered treatment

ACTIVE COMPARATOR

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

Drug: Lorazepam (drug)Drug: Lorazepam

Interventions

Lorazepam (drug)DRUG

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

Also known as: Ativan
Fixed-schedule treatmentSymptom-triggered treatment
LorazepamDRUG

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

Also known as: Ativan
Fixed-schedule treatmentSymptom-triggered treatment

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to give informed consent
  • Chronically maintained on prescription sedative-hypnotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23219, United States

Location

Related Publications (1)

  • 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.

    PMID: 16785215RESULT

MeSH Terms

Interventions

LorazepamPharmaceutical Preparations

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Michael F. Weaver, MD

    Virginia Commonwealth University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

April 1, 2001

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

April 11, 2016

Record last verified: 2016-04

Locations

US(1)