Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal
Condition: Alcohol Withdrawal
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Chlordiazepoxide; Gabapentin
Intervention type(s): Drug; Drug
Intervention description(s): 25mg four times daily x 3 days then tapered over 3 days; 300mg four times daily x 3 days then tapered over 3 days
Other intervention name(s): Librium; Neurontin
Intervention MeSH terms: Chlordiazepoxide; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment