The following clinical trials are currently actively researching the effects of Low Dose Naltrexone (LDN) in different disease conditions.  For further details, please visit the registry of federally and privately supported clinical trials currently being conducted in the United States and around the world at www.ClinicalTrials.gov.

The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease

The study was launched at Penn State in July 2008 and is expected to run until July 2010.  The study is designed to evaluate the effects of LDN in children with Crohn's disease by using the Pediatric Crohn's Disease Activity Index, plasma inflammatory markers, weight, and pediatric quality of life survey.  It will also examine the safety and toxicity of LDN in pediatric subjects with active Crohn's Disease and assess the mechanism by which Naltrexone exerts its action.

For more information about the trial, please visit the trial's website.

This study is currently recruiting participants.

Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome

The study will be an open-label test of various doses of LDN to determine whether LDN reduces Juvenile Primary Fibromyalgia Syndrome (JPFS) symptoms, and the appropriate dose at which it does so. Primary endpoints will be daily pain, fatigue, and sleep. Forty children with JPFS will be recruited.

This study is not yet recruiting.

Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder (PDD)

This study will examine the effects of LDN on children with autistic spectrum disorders. Fifty children aged three to six years will be recruited for the study. They will be randomly assigned to receive either LDN or placebo for two months after which the treatment groups will be switched over. Assessments of functioning will be obtained from a video-taped play session, and by parent and teacher questionnaires at baseline, after two months and after four months.

This study is not yet recruiting.

A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone

This is a randomized placebo-controlled, parallel-group, crossover-design study of the effects of LDN on the multiple sclerosis quality of life inventory.

This study is complete but not yet published.

Effects of Low Dose Naltrexone in Fibromyalgia

Both LDN and placebo will be administered to a small group of individuals with fibromyalgia and Gulf War Syndrome, both chronic multi-symptom illnesses, to assess the drug's efficacy in treating the condition.

This study is active, but not recruiting.

The Effects of Naltrexone on Active Crohn's Disease

The purpose of this study is to evaluate the effects of LDN in a blinded placebo-controlled study to determine the safety and efficacy of this compound in those with active Crohn's disease.

This study is active, but not recruiting.