Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

The investigators will compare the use of daily low dose naltrexone (LDN) (4.5 mg) compared
with placebo in subjects that have symptomatic inflammatory bowel disease (IBD). Our
subjects will be those with diagnosed with IBD and are symptomatic, defined by an
inflammatory bowel disease questionnaire (IBDQ) score < 170. The subjects will be randomly
assigned either placebo or LDN. They will take the IBDQ prior to starting the trial, 6
weeks, 12 weeks and 6 months after starting the medication. Participants have to remain on
their current IBD regimen throughout the trial and cannot make any changes within 4 weeks of
starting the trial. The investigators will have a safety phone call at 6 weeks and a follow
up letter at 12 weeks after starting the trial. The participants will be given a card to
keep with them with a phone number and email address if any adverse effects arise.

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