Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal

This study has been completed.
Information provided by (Responsible Party):
Christopher J. Stock, PharmD, VA Salt Lake City Health Care System Identifier:
First received: April 4, 2012
Last updated: June 20, 2012
Last verified: June 2012
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 Intervention Phase
Alcohol Withdrawal
Drug: Chlordiazepoxide
Drug: Gabapentin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Chlordiazepoxide and Gabapentin for Outpatient Alcohol Detoxification Treatment

Resource links provided by NLM:

Further study details as provided by VA Salt Lake City Health Care System:

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 ]

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 ]

Enrollment: 27
Study Start Date: March 2004
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chlordiazepoxide Drug: Chlordiazepoxide
25mg qid x 3 days then tapered over 3 days
Experimental: Gabapentin Drug: Gabapentin
300mg qid x 3 days then tapered over 3 days


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Alcohol dependent at risk for withdrawal symptoms

Exclusion Criteria:

  • Benzodiazepine dependent
  Contacts and Locations
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Please refer to this study by its identifier: NCT01573052

United States, Utah
George E Wahlen VA Medical Center
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
VA Salt Lake City Health Care System
Principal Investigator: Christopher J Stock, PharmD Salt Lake VA Health Care System
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christopher J. Stock, PharmD, Investigational pharmacist, VA Salt Lake City Health Care System Identifier: NCT01573052     History of Changes
Other Study ID Numbers: UU40574 
Study First Received: April 4, 2012
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents processed this record on April 27, 2016