Trial Information

Summary: Clinical trial to test a study drug in Patients with Chronic Hepatitis C

The purpose of this study is to evaluate the safety and effectiveness of an FDA-approved study drug as a sleep aid as compared to placebo (an inactive substance) in the treatment of insomnia associated with interferon-induced insomnia in patients with chronic hepatitis C (CHC). In addition, another purpose of this study is to evaluate whether successful treatment of insomnia decreases the likelihood of developing depression which can occur during interferon treatment.

Study drug and study procedures will be made available to you at no cost.

To qualify, you must:

• Be at least 18 through 65 years of age
• A documented history of chronic hepatitis C
• Currently receiving interferon treatment in the Gastroenterology Department at Montefiore Medical Center

You will not qualify if you:

• Are pregnant or breast-feeding
• A prior history of a suicide attempt in the past 6 months
• A current history of any of the following sleep disorders- sleep apnea, periodic limb movement disorder, or restless leg syndrome.
• Any unstable medical illnesses
• Have participated in another clinical trial within the past 30 days.

Research being conducted by:

If you would like to learn more about participating in this study, please send an e-mail message using the form below.