Overview

The Effects of Naltrexone on Active Crohn's Disease

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
Summary
It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the bowel and quality of life in subjects with active Crohn's disease compared to placebo. In order to test this hypothesis the following specific aims are proposed: 1. Evaluate the effects of low dose naltrexone compared to placebo on the activity of Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and quality of life surveys; 2. Examine the effects of naltrexone given over 3 months compared to 6 months for durability of response; 3. Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's disease, and 4. Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin levels of subjects on therapy. Purpose statement: The purpose of this study is to evaluate the effects of low dose naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this compound in those with active Crohn's disease.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Milton S. Hershey Medical Center
Penn State University
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Broad Foundation
Treatments:
Naltrexone
Criteria
Inclusion Criteria:

- All subjects must give written informed consent

- Male or female subjects, > 18 years

- Patients must have endoscopic, histologic, or radiographic confirmed Crohn's Disease.

- Patients must have a Crohn's Disease Activity Index (CDAI) of at least 220 at Baseline

- Stable doses of medications for Crohn's disease over proceeding 4 weeks (for
aminosalicylates and steroids: prednisone of 10mg or less daily and Entocort 3 mg/ day
are allowed), and 12 weeks for azathioprine or 6-mercaptopurine.)

Exclusion Criteria:

- Subjects with ostomies or ileorectal anastomosis from prior surgical colectomy.

- Subjects who received infliximab (Remicade) within 8 weeks of study screening or
humira for 4 weeks.

- Subjects requiring steroids either intravenously or prednisone >10mg /day or Entocort
> 3 mg daily.

- Subjects with short-bowel syndrome.

- Abnormal liver enzymes at screening visit or known hepatitis or cirrhosis

- Hemoglobin less than 10.

- Subjects with cancer (other than skin cancer) in past 5 years.

- Women of childbearing potential unless surgically sterile or using adequate
contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide),
and willing and able to continue contraception for 3 months after the completion of
the study.

- Women who are pregnant or breastfeeding