Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
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.
Inflammatory Bowel Disease
Drug: Low dose naltrexone
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease|
- An increase in the subjects inflammatory bowel disease questionnaire score [ Time Frame: 6 weeks, 12 weeks, and 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01810185
|United States, California|
|Santa Barbara Cottage Hospital|
|Santa Barbara, California, United States, 93105|
|Principal Investigator:||Erick J Imbertson, M.D.||Santa Barabara Cottage Hospital|