Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Santa Barbara Cottage Hospital

Status and phase: Withdrawn; Phase 2

Conditions: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Treatments: Drug: Placebo; Drug: Low dose naltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT01810185

LDN in IBD

SBCH- LDN in IBD (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Low dose naltrexone

Experimental group

Description:

Subjects in this arm will recieve low dose naltrexone (4.5 mg) daily for 12 weeks.

Treatment:

Drug: Low dose naltrexone

Placebo

Placebo Comparator group

Description:

Subjects in this arm will recieve a placebo daily for 12 weeks.

Treatment:

Drug: Placebo