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Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher J. Stock, PharmD, 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
History of Changes
  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 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:

U.S. FDA Resources

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

  Eligibility

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

Inclusion Criteria:

  • Alcohol dependent at risk for withdrawal symptoms

Exclusion Criteria:

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

Locations
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
Investigators
Principal Investigator: Christopher J Stock, PharmD Salt Lake VA Health Care System
  More Information

No publications provided

Responsible Party: Christopher J. Stock, PharmD, Investigational pharmacist, VA Salt Lake City Health Care System
ClinicalTrials.gov 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:
Chlordiazepoxide
Gabapentin
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Adjuvants, Anesthesia
GABA Modulators
GABA Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antimanic Agents

ClinicalTrials.gov processed this record on May 19, 2013