The etiology of the pruritus of cholestasis is unknown and its treatment unsatisfactory. The pruritus of cholestasis has a negative impact on the quality of life of patients and can be so severe that it can be an indication for liver transplantation, ever in the face of good hepatic function. Accordingly, the provision of satisfactory treatment for this symptom is needed. Pruritus is a nociceptive stimulus that elicits the reflect act of scratching. Because the perception of nociception can be altered by drugs that mediate antinociception, this type of drugs may be of value in the treatment of pruritus. Recent data from animal and clinical studies suggest that gabapentin mediates antinociception/analgesia.
The specific aim of this study is to compare the effect of gabapentin to that of placebo on the pruritus of cholestasis. Adult patients with pruritus secondary to liver disease will be studied, in a single blind, randomized, placebo controlled trial. Because pruritus is a perception, it cannot be objectively quantitated. In contrast, the behavioral manifestation of the pruritus of cholestasis, scratching activity, can be objectively quantitated. The primary end point of this study is scratching activity. Scratching activity will be measured by a stem designed specifically to record this behavior. The potential outcome of this study is the identification of an effective form of therapy for the pruritus of cholestasis.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Research Grants (R03)
Project #
1R03DK058682-01
Application #
6229363
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Robuck, Patricia R
Project Start
2001-02-15
Project End
2003-01-31
Budget Start
2001-02-15
Budget End
2003-01-31
Support Year
1
Fiscal Year
2001
Total Cost
$85,250
Indirect Cost
Name
Columbia University (N.Y.)
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
167204994
City
New York
State
NY
Country
United States
Zip Code
10032