Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

NCT01810185 | Withdrawn Phase 2

• 2 other identifiers: LDN in IBDSBCH- LDN in IBD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Low dose naltrexone

EXPERIMENTAL

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

Drug: Low dose naltrexone

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Low dose naltrexone DRUG

4.5 mg daily for 12 weeeks

Also known as: Naltrexone

Low dose naltrexone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santa Barbara Cottage Hospital: lead

Study Sites (1)

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

Related Publications (4)

• 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.

  PMID: 17222320 RESULT

• 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.

  PMID: 23188075 RESULT

• 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.

  PMID: 21991594 RESULT

• 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.

  PMID: 24558033 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Erick J Imbertson, M.D.

  Santa Barabara Cottage Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 13, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

US (1)