The Effects of Naltrexone on Active Crohn's Disease
Condition: Inflammation; Crohn's Disease
MeSH terms: Crohn Disease; Inflammation
Intervention: Naltrexone-HCl; Placebo
Intervention description: naltrexone 4.5 mg; Placebo
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: naltrexone; LDN; IBD; Inflammatory bowel disease

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects must give written informed consent

          -  Male or female subjects, > 18 years

          -  Patients must have endoscopic, histologic, or radiographic confirmed Crohn's Disease.

          -  Patients must have a Crohn's Disease Activity Index (CDAI) of at least 220 at Baseline

          -  Stable doses of medications for Crohn's disease over proceeding 4 weeks (for
             aminosalicylates and steroids: prednisone of 10mg or less daily and Entocort 3 mg/ day
             are allowed), and 12 weeks for azathioprine or 6-mercaptopurine.)

        Exclusion Criteria:

          -  Subjects with ostomies or ileorectal anastomosis from prior surgical colectomy.

          -  Subjects who received infliximab (Remicade) within 8 weeks of study screening or
             humira for 4 weeks.

          -  Subjects requiring steroids either intravenously or prednisone >10mg /day or Entocort
             > 3 mg daily.

          -  Subjects with short-bowel syndrome.

          -  Abnormal liver enzymes at screening visit or known hepatitis or cirrhosis

          -  Hemoglobin less than 10.

          -  Subjects with cancer (other than skin cancer) in past 5 years.

          -  Women of childbearing potential unless surgically sterile or using adequate
             contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide),
             and willing and able to continue contraception for 3 months after the completion of
             the study.

          -  Women who are pregnant or breastfeeding