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Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01810185
Recruitment Status : Withdrawn (Low patient enrollment)
First Posted : March 13, 2013
Last Update Posted : November 20, 2014
Information provided by (Responsible Party):
Erick Jordan Imbertson, Santa Barbara Cottage Hospital

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Drug: Low dose naltrexone Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
Study Start Date : March 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Low dose naltrexone
Subjects in this arm will recieve low dose naltrexone (4.5 mg) daily for 12 weeks.
Drug: Low dose naltrexone
4.5 mg daily for 12 weeeks
Other Name: Naltrexone

Placebo Comparator: Placebo
Subjects in this arm will recieve a placebo daily for 12 weeks.
Drug: Placebo

Primary Outcome Measures :
  1. An increase in the subjects inflammatory bowel disease questionnaire score [ Time Frame: 6 weeks, 12 weeks, and 6 months ]
    Participants will fill-out a questionnaire called the IBDQ at enrollment, 6 weeks, 12 weeks, and 6 months after enrollment. The IBDQ is a validated instrument often used in routine care and studies of patients with IBD (Appendix E). The IBDQ measures the activity of IBD and quality of life. It includes 32 questions placed into 4 domains: bowel, social, emotional and systemic. Each question is ranked from 1-7, 1 being the poorest quality of life and 7 being the best quality of life8. A score of >170 means that a patient is clinically in remission and an increase in score between 16 and 32 are considered a meaningful improvement in symptoms.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810185

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United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Santa Barbara Cottage Hospital
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Principal Investigator: Erick J Imbertson, M.D. Santa Barabara Cottage Hospital
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erick Jordan Imbertson, M.D., Santa Barbara Cottage Hospital
ClinicalTrials.gov Identifier: NCT01810185    
Other Study ID Numbers: LDN in IBD
SBCH- LDN in IBD ( Other Identifier: Santa Barbara Cottage Hospital )
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014
Keywords provided by Erick Jordan Imbertson, Santa Barbara Cottage Hospital:
Inflammatory Bowel Disease
Crohn's disease
Ulcerative colitis
Low Dose Naltrexone
Inflammatory Bowel Disease Questionnaire
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents