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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.
 
ClinicalTrials.gov Identifier: NCT01573052
Recruitment Status : Completed
First Posted : April 6, 2012
Results First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Christopher J. Stock, PharmD, VA Salt Lake City Health Care System

Study Description
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Brief 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.

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

Detailed Description:

Chlordiazepoxide 25 mg and matching placebo capsules or gabapentin 300 mg and matching placebo capsules were were used. The chlordiazepoxide/placebo and gabapentin/placebo capsules were not identical in appearance. Study medications were packaged into a 7-day medication organizer. The dosing for each subject was either gabapentin 1200mg or chlordiazepoxide 100 mg orally days 1-3, gabapentin 900 mg or chlordiazepoxide 75 mg day 4, gabapentin 600 mg or chlordiazepoxide 50 mg day 5, and gabapentin 300 mg or chlordiazepoxide 25 mg day 6.

Adherence was assessed by pill counts and serum samples were obtained for study drug analysis. Serum samples were batched and sent to a contract laboratory so that study clinicians were blinded to the results until after the trial was completed. Presence of the assigned study medication in the blood served as a surrogate adherence marker.

Subjects also received prescriptions for daily oral therapeutic multiple vitamin tablets, folic acid 1 mg, and thiamine 100 mg.

A psychiatric history and physical examination, breath alcohol concentration, vital signs, CIWA-Ar (alcohol withdrawal scale), and blood chemistry including transaminases and complete blood cell count were obtained for baseline for all participants. Subjects were seen on weekdays for clinic follow-up appointments. Assessments performed at each study visit included CIWA-Ar, ESS (Epworth Sleepiness Scale), PACS (Penn Alcohol Craving Scale), and a brief examination to document mental status and assess coordination, which included assessment of stance, tandem gait, Romberg test, pronator drift, toe and heel walk, rapid-alternating-movements, and point-to-point movements. Breath alcohol concentration (BAC) was also measured (AlcoSensor, Intoximeters, Inc.) at each visit.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 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
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Chlordiazepoxide
Chlordiazepoxide 25mg capsule or matching placebo capsule
 Drug: Chlordiazepoxide
25mg four times daily x 3 days then tapered over 3 days
Other Name: Librium
Experimental: Gabapentin
Gabapentin 300mg capsule or matching placebo capsule
 Drug: Gabapentin
300mg four times daily x 3 days then tapered over 3 days
Other Name: Neurontin


Outcome Measures
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Primary Outcome Measures :
  1. Epworth Sleepiness Scale (ESS) [ Time Frame: 1 week ]
    ESS is an 8 item-scale and scores range between 0 and 24. The higher the score implies more daytime sleepiness.

  2. PENN Alcohol Craving Scale [ Time Frame: 1 week ]
    PENN is a 5 item self-rated scale of alcohol craving. Scores range from 0 (little craving for alcohol) to 30 (irresistable urge to drink alcohol)


Secondary Outcome Measures :
  1. Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar) [ Time Frame: 1 week ]
    CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Many previously publications suggest a total score of 8-10 is severe enough to warrant medication treatment. Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores > 8 represent more withdrawal symptoms and greater severity


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Alcohol dependent at risk for withdrawal symptoms

Exclusion Criteria:

  • Benzodiazepine dependent
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01573052


Locations
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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
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Principal Investigator: Christopher J Stock, PharmD Salt Lake VA Health Care System
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christopher J. Stock, PharmD, Investigational pharmacist, VA Salt Lake City Health Care System
ClinicalTrials.gov Identifier: NCT01573052    
Other Study ID Numbers: UU40574
First Posted: April 6, 2012    Key Record Dates
Results First Posted: August 17, 2020
Last Update Posted: August 17, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Chlordiazepoxide
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
 Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Adjuvants, Anesthesia
Hypnotics and Sedatives
GABA Modulators
GABA Agents