Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT01810185

Recruitment Status : Withdrawn (Low patient enrollment)

First Posted : March 13, 2013

Last Update Posted : November 20, 2014

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Erick Jordan Imbertson, Santa Barbara Cottage Hospital

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.

Condition or disease	Intervention/treatment	Phase
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis	Drug: Low dose naltrexone Drug: Placebo	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
Study Start Date :	March 2013
Estimated Primary Completion Date :	March 2014
Estimated Study Completion Date :	March 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Ulcerative colitis Crohn disease

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Low dose naltrexone Subjects in this arm will recieve low dose naltrexone (4.5 mg) daily for 12 weeks.	Drug: Low dose naltrexone 4.5 mg daily for 12 weeeks Other Name: Naltrexone
Placebo Comparator: Placebo Subjects in this arm will recieve a placebo daily for 12 weeks.	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

An increase in the subjects inflammatory bowel disease questionnaire score [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810185

Locations

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United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105

Sponsors and Collaborators

Santa Barbara Cottage Hospital

Investigators

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Principal Investigator:	Erick J Imbertson, M.D.	Santa Barabara Cottage Hospital

More Information

Publications of Results:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Erick Jordan Imbertson, M.D., Santa Barbara Cottage Hospital
ClinicalTrials.gov Identifier:	NCT01810185
Other Study ID Numbers:	LDN in IBD SBCH- LDN in IBD ( Other Identifier: Santa Barbara Cottage Hospital )
First Posted:	March 13, 2013 Key Record Dates
Last Update Posted:	November 20, 2014
Last Verified:	November 2014

Keywords provided by Erick Jordan Imbertson, Santa Barbara Cottage Hospital:


Inflammatory Bowel Disease Crohn's disease Ulcerative colitis	Naltrexone Low Dose Naltrexone Inflammatory Bowel Disease Questionnaire

Additional relevant MeSH terms:

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Crohn Disease Colitis Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases	Colonic Diseases Naltrexone Alcohol Deterrents Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents

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