Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

• Status: Withdrawn
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will be looking at the efficacy of the use of once daily use of low dose naltrexone (4.5mg) in subjects with symptomatic inflammatory bowel disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Santa Barbara Cottage Hospital
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• Patients with symptomatic Crohn's disease or ulcerative colitis (defined as a response to the Inflammatory Bowel Disease Questionnaire less than 170)

• Confirmed Crohn's disease or ulcerative colitis through radiographic, endoscopic and/or histologic criteria

• On a stable dose of medication for IBD (i.e. no change in medication within 4 weeks of study enrollment)

• Age 18 or older

Exclusion Criteria:

• Patients on opioids or immodium within 7 days of starting the investigational therapy

• Women who are breastfeeding, pregnant, or plan on becoming pregnant within the next year

• Patients on Lomotil or opioid analgesics

• Patients already on low dose naltrexone

• Women of child bearing age not willing to use contraception or abstinence

• A history of the following diseases or procedures:

• Acute hepatitis

• Liver failure

• Ileoanal anastomosis

• Short bowel syndrome

• Abnormal liver enzymes