Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal | RxWiki

Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Alcohol Withdrawal
Intervention	Drug: Chlordiazepoxide Drug: Gabapentin
Phase	Phase 4
Sponsor	VA Salt Lake City Health Care System
Responsible Party	VA Salt Lake City Health Care System
ClinicalTrials.gov Identifier	NCT01573052
First Received	April 4, 2012
Last Updated	June 20, 2012
Last verified	June 2012

Tracking Information[ + expand ][ + ]

First Received Date	April 4, 2012
Last Updated Date	June 20, 2012
Start Date	March 2004
Estimated Primary Completion Date	September 2010
Current Primary Outcome Measures	Epworth Sleepiness Scale [Time Frame: 1 week] [Designated as safety issue: Yes] PENN Alcohol Craving Scale [Time Frame: 1 week] [Designated as safety issue: No]
Current Secondary Outcome Measures	Ataxia [Time Frame: 1 week] [Designated as safety issue: Yes]Brief neurological exam for coordination including assessment of stance, tandem gait, romberg test, pronator drift, toe and heel walk, rapid-alternating-movements, and point-to-point movements Withdrawal assessment scale [Time Frame: 1 week] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal
Official Title	Comparison of Chlordiazepoxide and Gabapentin for Outpatient Alcohol Detoxification Treatment
Brief 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Alcohol Withdrawal
Intervention	Drug: Chlordiazepoxide 25mg qid x 3 days then tapered over 3 days Drug: Gabapentin 300mg qid x 3 days then tapered over 3 days
Study Arm (s)	Active Comparator: Chlordiazepoxide Experimental: Gabapentin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	27
Estimated Completion Date	September 2010
Estimated Primary Completion Date	August 2010
Eligibility Criteria	Inclusion Criteria: - Alcohol dependent at risk for withdrawal symptoms Exclusion Criteria: - Benzodiazepine dependent
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01573052
Other Study ID Numbers	UU40574
Has Data Monitoring Committee	Yes
Information Provided By	VA Salt Lake City Health Care System
Study Sponsor	VA Salt Lake City Health Care System
Collaborators	Not Provided
Investigators	Principal Investigator: Christopher J Stock, PharmD Salt Lake VA Health Care System
Verification Date	June 2012

Locations[ + expand ][ + ]