NCT00663117

The Effects of Naltrexone on Active Crohn's Disease

The Effects of Naltrexone in Active Crohn's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the bowel and quality of life in subjects with active Crohn's disease compared to placebo. In order to test this hypothesis the following specific aims are proposed: 1. Evaluate the effects of low dose naltrexone compared to placebo on the activity of Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and quality of life surveys; 2. Examine the effects of naltrexone given over 3 months compared to 6 months for durability of response; 3. Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's disease, and 4. Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin levels of subjects on therapy. Purpose statement: The purpose of this study is to evaluate the effects of low dose naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this compound in those with active Crohn's disease.

Detailed description

Study design : The study is designed as a double-blind placebo controlled study for 3 months followed by a pseudo cross-over such that all subjects receiving placebo the first 3 months will receive active drug the second 3 months and all receiving naltrexone the first 3 months remain on the drug the last 3 months of this 6 month study.

Conditions

• Inflammation
• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Naltrexone-HCl	naltrexone 4.5 mg
DRUG	Placebo	Placebo

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-04-22
• Last updated: 2018-10-02
• Results posted: 2013-05-17

Locations

1 site across 1 country: United States