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Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal

NCT01573052 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-08-17

Study results available
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Summary

A randomized, double-blind controlled trial comparing treatment outcomes between chlordiazepoxide, or gabapentin to treat alcohol withdrawal syndrome in alcohol dependent veteran subjects. The objective of this trial is to compare the safety and effectiveness of these two medications. Intervention is a fixed dose taper of chlordiazepoxide, or gabapentin over 6 days. Subjects will be evaluated for 7-10 days to monitor alcohol abstinence, withdrawal severity scores, adverse events including ataxia, sedation, cognitive function and alcohol craving.

Conditions

  • Alcohol Withdrawal

Interventions

DRUG

Chlordiazepoxide

25mg four times daily x 3 days then tapered over 3 days

DRUG

Gabapentin

300mg four times daily x 3 days then tapered over 3 days

Sponsors & Collaborators

  • VA Salt Lake City Health Care System

    lead FED

Principal Investigators

  • Christopher J Stock, PharmD · Salt Lake VA Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2010-08-31
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01573052 on ClinicalTrials.gov