Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal

Phase 4

Completed

Conditions: Alcohol Withdrawal

Interventions: Drug: Chlordiazepoxide
Drug: Gabapentin

Registration Number: NCT01573052

Lead Sponsor: VA Salt Lake City Health Care System

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 26

Inclusion Criteria

Alcohol dependent at risk for withdrawal symptoms

Exclusion Criteria

Benzodiazepine dependent

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlordiazepoxide	Chlordiazepoxide	Chlordiazepoxide 25mg capsule or matching placebo capsule
Gabapentin	Gabapentin	Gabapentin 300mg capsule or matching placebo capsule

Primary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale (ESS)	1 week	ESS is an 8 item-scale and scores range between 0 and 24. The higher the score implies more daytime sleepiness.
PENN Alcohol Craving Scale	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

Name	Time	Method
Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar)	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