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Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

NCT ID: NCT01810185

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-03-31

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.

Conditions

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Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low dose naltrexone

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

Group Type EXPERIMENTAL

Low dose naltrexone

Intervention Type DRUG

4.5 mg daily for 12 weeeks

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Low dose naltrexone

4.5 mg daily for 12 weeeks

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Naltrexone

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Santa Barbara Cottage Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erick Jordan Imbertson

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erick J Imbertson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Santa Barabara Cottage Hospital

Locations

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Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17222320 (View on PubMed)

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.

Reference Type RESULT
PMID: 23188075 (View on PubMed)

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.

Reference Type RESULT
PMID: 21991594 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24558033 (View on PubMed)

Other Identifiers

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SBCH- LDN in IBD

Identifier Type: OTHER

Identifier Source: secondary_id

LDN in IBD

Identifier Type: -

Identifier Source: org_study_id