NCT01810185

Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Santa Barbara Cottage Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammatory Bowel Disease
• Crohn's Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Low dose naltrexone	4.5 mg daily for 12 weeeks
DRUG	Placebo

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-03-13
• Last updated: 2014-11-20

Locations

1 site across 1 country: United States