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Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal

Information source: VA Salt Lake City Health Care System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Withdrawal

Intervention: Chlordiazepoxide (Drug); Gabapentin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: VA Salt Lake City Health Care System

Official(s) and/or principal investigator(s):
Christopher J Stock, PharmD, Principal Investigator, Affiliation: Salt Lake VA Health Care System

Summary

A randomized, double-blind controlled trial comparing treatment outcomes between chloriazepide, 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.

Clinical Details

Official title: Comparison of Chlordiazepoxide and Gabapentin for Outpatient Alcohol Detoxification Treatment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Epworth Sleepiness Scale

PENN Alcohol Craving Scale

Secondary outcome:

Ataxia

Withdrawal assessment scale

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Alcohol dependent at risk for withdrawal symptoms

Exclusion Criteria:

- Benzodiazepine dependent

Locations and Contacts

George E Wahlen VA Medical Center, Salt Lake City, Utah 84148, United States
Additional Information

Starting date: March 2004
Last updated: June 20, 2012

Page last updated: August 23, 2015

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