Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT01810185

Run by

Santa Barbara Cottage Hospital

People needed

0

Starts

2013-03-01

Expected to finish

2014-03-01

Last updated by the study team

2014-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Santa Barbara Cottage Hospital — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

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