Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Phase 2

Withdrawn

• Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis
• Interventions: Drug: Low dose naltrexone; Drug: Placebo

• Registration Number: NCT01810185
• Lead Sponsor: Santa Barbara Cottage Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-13
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose naltrexone	Low dose naltrexone	Subjects in this arm will recieve low dose naltrexone (4.5 mg) daily for 12 weeks.
Placebo	Placebo	Subjects in this arm will recieve a placebo daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
An increase in the subjects inflammatory bowel disease questionnaire score	6 weeks, 12 weeks, and 6 months	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.

Trial Locations

Locations (1)

Santa Barbara Cottage Hospital; 🇺🇸 Santa Barbara, California, United States