Phenobarbital for Acute Alcohol Withdrawal

NCT ID: NCT01184417

Last Updated: 2012-03-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-03-31

Brief Summary

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Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.

Detailed Description

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Conditions

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Alcohol Withdrawal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Phenobarbital group

10 mg/kg IV phenobarbital in 100 ml saline

Group Type ACTIVE_COMPARATOR

10 mg/kg IV phenobarbital in 100 ml saline

Intervention Type DRUG

10 mg/kg IV phenobarbital in 100 ml saline

Placebo group

100 ml saline

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

100 m l saline

Interventions

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10 mg/kg IV phenobarbital in 100 ml saline

10 mg/kg IV phenobarbital in 100 ml saline

Intervention Type DRUG

placebo

100 m l saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Need for admission to hospital for acute alcohol withdrawal

Exclusion Criteria

* allergy to phenobarbital, lorazepam, age\<18 or \>65
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alameda County Medical Center

OTHER

Sponsor Role collaborator

Jonathan Rosenson

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Rosenson

Jonathan Rosenson MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Alameda County Medical Center

Oakland, California, United States

Site Status

Countries

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United States

Other Identifiers

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AlamedaCountyMC

Identifier Type: -

Identifier Source: org_study_id

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