Gabapentin to Treat Itch in Patients With Liver Disease

Double-blind, randomized, placebo-controlled study of gabapentin for the pruritus of cholestasis. Duration: 4 weeks. Some travel funds available for patients from out of the NY area for all the visits. Hospitalization at baseline and after 4 weeks of treatment. One outpatient department visit at week 2.

All patients have to be referred by their physician, who will receive a summary of the results at the end of the patient's study participation.

If patients are randomized to active drug and respond to it with decrease in pruritus, a one week supply of medication is given. The referring physician could prescribe the drug for long term use. If the patient is randomized to placebo they can be treated with active medication provided by the study for 4 weeks, at end of which, the drug could be prescribed by referring physician if the patient responds to the drug with decrease in the pruritus.

Inclusion criteria

include:

• Patients from ages 18 to 80 with chronic pruritus secondary to liver disease

Patients must have:

• a normal chest X- ray during the previous year
• normal thyroid function tests (treated thyroid dysfunction is acceptable)
• controlled diabetes, if diabetes mellitus is present
• negative fecal occult blood within the previous year

Exclusion criteria

include:

• history of hepatic encephalopathy
• decompensated liver disease as suggested by ascites and history of variceal bleeding
• malignancy
• inability to practice contraception
• pregnancy
• creatinine > 1.7 mg/dl
• hemoglobin < 10mg/dl
• S/P liver transplantation
• HIV infection