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Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01573052
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : June 21, 2012
Information provided by (Responsible Party):
Christopher J. Stock, PharmD, VA Salt Lake City Health Care System

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.

Condition or disease Intervention/treatment Phase
Alcohol Withdrawal Drug: Chlordiazepoxide Drug: Gabapentin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Chlordiazepoxide and Gabapentin for Outpatient Alcohol Detoxification Treatment
Study Start Date : March 2004
Primary Completion Date : August 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Epworth Sleepiness Scale [ Time Frame: 1 week ]
  2. PENN Alcohol Craving Scale [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Ataxia [ Time Frame: 1 week ]
    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

  2. Withdrawal assessment scale [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Alcohol dependent at risk for withdrawal symptoms

Exclusion Criteria:

  • Benzodiazepine dependent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents
Adjuvants, Anesthesia
Hypnotics and Sedatives
GABA Modulators