A Comparison of Lorazepam and Diazepam in the Treatment o... | NCT00523185

Studies
A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal

NCT00523185

Sponsor

Stanford University

Status

Completed

Last Update Posted

Aug 31, 2007Estimated

Enrollment

55Actual

Phase

Not Applicable

Conditions

Alcohol Withdrawal

Interventions

Lorazepam
Diazepam

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Not provided

Completion Date

Nov 2004Actual

First Submitted Date

Aug 29, 2007

First Submission Date that Met QC Criteria

Aug 29, 2007

First Posted Date

Aug 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2007

Last Update Posted Date

Aug 31, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Despite the frequent use of benzodiazepines for the treatment of alcohol withdrawal, studies comparing the efficacy of long and short half-life benzodiazepines in the treatment of alcohol withdrawal have shown mixed results. Due to the conflicting nature of published reports, clinicians have no clear indication as to which type of agent is preferable. The purpose of this study is to compare the efficacy of two commonly accepted medications in the treatment of alcohol withdrawal, diazepam and lorazepam, which are long and short half-life benzodiazepines, respectively.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Active Comparator		Drug: Diazepam
1	Active Comparator		Drug: Lorazepam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lorazepam	Drug	Lorazepam 1 to 2 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Secondary outcome measures include total benzodiazepine use.		one to two weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose R Maldonado, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Palo Alto Veterans Affairs Hospital System		Palo Alto	California	94304	United States
Stanford Hospital and Clinics

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22898443	Derived	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.

ID	Term
D001570	Benzodiazepinones
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring