Phenobarbital for Acute Alcohol Withdrawal

Jonathan Rosenson

Status: Completed

Conditions: Alcohol Withdrawal

Treatments: Drug: placebo; Drug: 10 mg/kg IV phenobarbital in 100 ml saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01184417

AlamedaCountyMC

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Need for admission to hospital for acute alcohol withdrawal

Exclusion criteria

• allergy to phenobarbital, lorazepam, age<18 or >65

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups, including a placebo group

Phenobarbital group

Active Comparator group

Description:

10 mg/kg IV phenobarbital in 100 ml saline

Treatment:

Drug: 10 mg/kg IV phenobarbital in 100 ml saline

Placebo group

Placebo Comparator group

Description:

100 ml saline

Treatment:

Drug: placebo