CLINICAL TRIAL ON PRURITUS     (Results will be announced at completion of project)

Principal Investigator: Nora V. Bergasa, M.D.

Associated Professor of Clinical Medicine

Columbia University, College of Physicians and Surgeons

We are conducting an NIH-funded double blind, placebo-controlled study on the use of the drug gabapentin for the treatment of itch associated with liver disease (IRB Protocol #9618). Patients will be evaluated in the outpatient facility of the Irving Center for Clinical Investigation at the Columbia-Presbyterian Medical Center in New York City. Once eligibility status is confirmed, patients will be admitted for baseline evaluation of itch before randomization and after completion of the four week treatment period. There are some travel funds available for patients from outside the tri-state area to cover each of the trips to New York in the amount of $240 per trip.

Inclusion criteria include:

1) Patients between the ages 18 to 80 with chronic pruritus secondary to liver disease

Patients must have:

1) a normal chest X- ray during the previous year

2) normal thyroid function tests (treated thyroid dysfunction is acceptable)

3) controlled diabetes, if diabetes mellitus is present

4) negative fecal occult blood within the previous year

Exclusion criteria include:

1) history of hepatic encephalopathy

2) decompensated liver disease as suggested by ascites and history of variceal bleeding

3) malignancy

4) inability to practice contraception

5) pregnancy

6) creatinine > 1.7 mg/dl

7) hemoglobin < 10mg/dl

8) S/P liver transplantation

9) HIV infection

The referring physician will be given pertinent follow-ups during the study, and a summary at the end of the participation of the patients you refer. Care of the patient for her/his liver condition will continue to be rendered by the referring physician.

We can be contacted at (212) 305-1021 to discuss the study for patients who may meet criteria.

Yours very sincerely,

Nora V. Bergasa, M.D.

Associate Professor of Clinical Medicine