Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

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

Intervention / Treatment
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* Drug: Low dose naltrexone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose naltrexone<br>Subjects in this arm will recieve low dose naltrexone (4.5 mg) daily for 12 weeks. | Drug: Low dose naltrexone<br>* 4.5 mg daily for 12 weeeks<br>* Other names: Naltrexone;|
| Placebo Comparator: Placebo<br>Subjects in this arm will recieve a placebo daily for 12 weeks. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An increase in the subjects inflammatory bowel disease questionnaire score | Participants will fill-out a questionnaire called the IBDQ at enrollment, 6 weeks, 12 weeks, and 6 months after enrollment. The IBDQ is a validated instrument often used in routine care and studies of patients with IBD (Appendix E). The IBDQ measures the activity of IBD and quality of life. It includes 32 questions placed into 4 domains: bowel, social, emotional and systemic. Each question is ranked from 1-7, 1 being the poorest quality of life and 7 being the best quality of life8. A score of >170 means that a patient is clinically in remission and an increase in score between 16 and 32 are considered a meaningful improvement in symptoms. | 6 weeks, 12 weeks, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease, Crohn's disease, Ulcerative colitis, Naltrexone, Low Dose Naltrexone, Inflammatory Bowel Disease Questionnaire