Phase 4 N=26 Randomized Quadruple-blind Treatment

Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal

Alcohol Withdrawal

Bottom Line

View on ClinicalTrials.gov: NCT01573052 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Epworth Sleepiness Scale (ESS) — 6.35; 2.65 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Chlordiazepoxide (Drug); Gabapentin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Salt Lake City Health Care System
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Epworth Sleepiness Scale (ESS)	6.35; 2.65	—
PRIMARY PENN Alcohol Craving Scale	16.78; 10.74	—
SECONDARY Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar)	3.29; 4.33	—

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.

Eligibility Criteria

Inclusion Criteria

Alcohol dependent at risk for withdrawal symptoms

Exclusion Criteria

Benzodiazepine dependent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01573052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.