Clinical trial NCT01810185: Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
Official title: Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
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
Lead sponsor: Santa Barbara Cottage Hospital
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: An increase in the subjects inflammatory bowel disease questionnaire score
timeFrame: 6 weeks, 12 weeks, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
Study officials:
affiliation: Santa Barabara Cottage Hospital
name: Erick J Imbertson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.