Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Sponsored by Santa Barbara Cottage Hospital

About this trial

Last updated 11 years ago

Study ID

LDN in IBD

Status

Withdrawn

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18+ Years

All Sexes

Trial Timing

Ended 12 years ago

What is this trial about?

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.

What are the participation requirements?

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