Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal
Comparison of Chlordiazepoxide and Gabapentin for Outpatient Alcohol Detoxification Treatment
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 4, 2012
CompletedFirst Posted
Study publicly available on registry
April 6, 2012
CompletedResults Posted
Study results publicly available
August 17, 2020
CompletedAugust 17, 2020
August 1, 2020
6.4 years
April 4, 2012
December 18, 2012
August 14, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Epworth Sleepiness Scale (ESS)
ESS is an 8 item-scale and scores range between 0 and 24. The higher the score implies more daytime sleepiness.
1 week
PENN Alcohol Craving Scale
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)
1 week
Secondary Outcomes (1)
Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar)
1 week
Study Arms (2)
Chlordiazepoxide
ACTIVE COMPARATORChlordiazepoxide 25mg capsule or matching placebo capsule
Gabapentin
EXPERIMENTALGabapentin 300mg capsule or matching placebo capsule
Interventions
25mg four times daily x 3 days then tapered over 3 days
300mg four times daily x 3 days then tapered over 3 days
Eligibility Criteria
You may qualify if:
- Alcohol dependent at risk for withdrawal symptoms
You may not qualify if:
- Benzodiazepine dependent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
George E Wahlen VA Medical Center
Salt Lake City, Utah, 84148, United States
Related Publications (1)
Stock CJ, Carpenter L, Ying J, Greene T. Gabapentin versus chlordiazepoxide for outpatient alcohol detoxification treatment. Ann Pharmacother. 2013 Jul-Aug;47(7-8):961-9. doi: 10.1345/aph.1R751. Epub 2013 Jun 18.
PMID: 23780805DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Christopher Stock
- Organization
- VA Salt Lake City Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher J Stock, PharmD
Salt Lake VA Health Care System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigational pharmacist
Study Record Dates
First Submitted
April 4, 2012
First Posted
April 6, 2012
Study Start
March 1, 2004
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
August 17, 2020
Results First Posted
August 17, 2020
Record last verified: 2020-08