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Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low dose naltrexone
Placebo
Sponsored by
Santa Barbara Cottage Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Inflammatory Bowel Disease, Crohn's disease, Ulcerative colitis, Naltrexone, Low Dose Naltrexone, Inflammatory Bowel Disease Questionnaire

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Santa Barbara Cottage Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Low dose naltrexone

Placebo

Arm Description

Subjects in this arm will recieve low dose naltrexone (4.5 mg) daily for 12 weeks.

Subjects in this arm will recieve a placebo daily for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2013
Last Updated
November 19, 2014
Sponsor
Santa Barbara Cottage Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01810185
Brief Title
Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
Official Title
Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Low patient enrollment
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Santa Barbara Cottage Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
Keywords
Inflammatory Bowel Disease, Crohn's disease, Ulcerative colitis, Naltrexone, Low Dose Naltrexone, Inflammatory Bowel Disease Questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose naltrexone
Arm Type
Experimental
Arm Description
Subjects in this arm will recieve low dose naltrexone (4.5 mg) daily for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects in this arm will recieve a placebo daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Low dose naltrexone
Other Intervention Name(s)
Naltrexone
Intervention Description
4.5 mg daily for 12 weeeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
An increase in the subjects inflammatory bowel disease questionnaire score
Description
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.
Time Frame
6 weeks, 12 weeks, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erick J Imbertson, M.D.
Organizational Affiliation
Santa Barabara Cottage Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17222320
Citation
Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS. Low-dose naltrexone therapy improves active Crohn's disease. Am J Gastroenterol. 2007 Apr;102(4):820-8. doi: 10.1111/j.1572-0241.2007.01045.x. Epub 2007 Jan 11.
Results Reference
result
PubMed Identifier
23188075
Citation
Smith JP, Field D, Bingaman SI, Evans R, Mauger DT. Safety and tolerability of low-dose naltrexone therapy in children with moderate to severe Crohn's disease: a pilot study. J Clin Gastroenterol. 2013 Apr;47(4):339-45. doi: 10.1097/MCG.0b013e3182702f2b.
Results Reference
result
PubMed Identifier
21991594
Citation
Low-dose naltrexone: tricking the body to heal itself. Exp Biol Med (Maywood). 2011 Sep;236(9):vii-viii. doi: 10.1258/ebm.2011.011f08. No abstract available.
Results Reference
result
PubMed Identifier
24558033
Citation
Segal D, Macdonald JK, Chande N. Low dose naltrexone for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2014 Feb 21;(2):CD010410. doi: 10.1002/14651858.CD010410.pub2.
Results Reference
derived

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Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

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