Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01810185
• Other study ID #: LDN in IBD
• Secondary ID: SBCH- LDN in IBD
• Status: Withdrawn
• Phase: Phase 2
• First received: March 11, 2013
• Last updated: November 19, 2014
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2014
• Source: Santa Barbara Cottage Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Drug:
• Low dose naltrexone
4.5 mg daily for 12 weeeks
• Placebo

Locations

Country	Name	City	State
United States	Santa Barbara Cottage Hospital	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Santa Barbara Cottage Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Low-dose naltrexone: tricking the body to heal itself. Exp Biol Med (Maywood). 2011 Sep;236(9):vii-viii. — View 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. — View 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. Epub 2007 Jan 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No