Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal

NCT ID: NCT01573052

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2010-09-30

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.

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.

Conditions

Alcohol Withdrawal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Chlordiazepoxide

Chlordiazepoxide 25mg capsule or matching placebo capsule

Group Type: ACTIVE_COMPARATOR

Chlordiazepoxide

Intervention Type: DRUG

25mg four times daily x 3 days then tapered over 3 days

Gabapentin

Gabapentin 300mg capsule or matching placebo capsule

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: DRUG

300mg four times daily x 3 days then tapered over 3 days

Interventions

Chlordiazepoxide

25mg four times daily x 3 days then tapered over 3 days

Intervention Type: DRUG

Gabapentin

300mg four times daily x 3 days then tapered over 3 days

Intervention Type: DRUG

Other Intervention Names

Librium; Neurontin

Eligibility Criteria

Inclusion Criteria

• Alcohol dependent at risk for withdrawal symptoms

Exclusion Criteria

• Benzodiazepine dependent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Salt Lake City Health Care System

FED

Sponsor Role: lead

Responsible Party

Christopher J. Stock, PharmD

Investigational pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher J Stock, PharmD

Role: PRINCIPAL_INVESTIGATOR

Salt Lake VA Health Care System

Locations

George E Wahlen VA Medical Center

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23780805 (View on PubMed)

Other Identifiers

UU40574

Identifier Type: -

Identifier Source: org_study_id