Trial reportJournal of clinical gastroenterology2013
Safety and tolerability of low-dose naltrexone therapy in children with moderate to severe Crohn's disease: a pilot study.
Trial report in Journal of clinical gastroenterology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
Who cites it
24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 52 citations in OpenAlex.
- Psychopharmacological Therapy Positively Modulates Disease Activity in Inflammatory Bowel Disease: A Systematic Review.International journal of molecular sciences · 2025Pooled it
- Low-Dose Naltrexone for Chronic Pain: Update and Systemic Review.Current pain and headache reports · 2020Pooled it
- Interventions for fatigue in inflammatory bowel disease.The Cochrane database of systematic reviews · 2020Pooled it
- Low dose naltrexone for induction of remission in Crohn's disease.The Cochrane database of systematic reviews · 2018Pooled it
- Low dose Naltrexone for induction of remission in inflammatory bowel disease patients.Journal of translational medicine · 2018Trial
- Low-Dose Naltrexone: What is the Evidence? A Narrative Review.Advances in therapy · 2026Review
- The next phase in Long COVID research: addressing the ethical challenges in trials of disease-modifying treatments.EClinicalMedicine · 2026Review
- Review
- Real-World Effectiveness and Tolerability of Low Dose Naltrexone to Treat Chronic Pain: A Retrospective Cohort Study of One Pain Physician's Practice.Journal of pain research · 2025Article
- Low-dose naltrexone's utility for non-cancer centralized pain conditions: a scoping review.Pain medicine (Malden, Mass.) · 2023Article
- The Utilization of Low Dose Naltrexone for Chronic Pain.CNS drugs · 2023Article
- Article
- Use of Contrave, Naltrexone with Bupropion, Bupropion, or Naltrexone and Major Adverse Cardiovascular Events: A Systematic Literature Review.Diabetes, metabolic syndrome and obesity : targets and therapy · 2022Review
- Current overview of opioids in progression of inflammatory bowel disease; pharmacological and clinical considerations.Molecular biology reports · 2021Review
- Developmental Considerations for the Use of Naltrexone in Children and Adolescents.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021Article
- Low-dose naltrexone as a treatment for chronic fatigue syndrome.BMJ case reports · 2020Article
- Potential Vaccines for Treating Crohn's DiseaseIranian biomedical journal · 2020Review
- The Effect of Low-Dose Naltrexone on Medication in Inflammatory Bowel Disease: A Quasi Experimental Before-and-After Prescription Database Study.Journal of Crohn's & colitis · 2018Article
- Low-Dose Naltrexone Treatment of Familial Benign Pemphigus (Hailey-Hailey Disease).JAMA dermatology · 2017Article
- Reduced Pro-Inflammatory Cytokines after Eight Weeks of Low-Dose Naltrexone for Fibromyalgia.Biomedicines · 2017Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundThere is an unmet need for safe and effective medicines to treat children with Crohn's disease. Recently, investigations have shown an association between endogenous opioid peptides and inflammatory cells.
aimsThe aims of this study were to evaluate the safety and tolerability of an opioid antagonist, naltrexone, in children with moderate to severe Crohn's disease.
methodsA pilot clinical trial was conducted in children with moderate to severe Crohn's disease. Fourteen subjects with a mean age of 12.3 years (range, 8 to 17 y) were enrolled. Children were randomized to placebo or naltrexone (0.1 mg/kg) orally for 8 weeks followed by open-labeled treatment with 8 additional weeks of naltrexone. Safety and toxicity were monitored by physical examinations and blood chemistries. Clinical activity was assessed by the Pediatric Crohn's Disease Activity Index (PCDAI) and Quality of life was monitored by the Impact III survey.
resultsOral naltrexone was well tolerated without any serious adverse events in children with moderate to severe Crohn's disease. PCDAI scores significantly decreased from pretreatment values (34.2±3.3) with an 8-week course of naltrexone therapy (21.7±3.9) (P=0.005). Twenty-five percent of those treated with naltrexone were considered in remission (score ≤10) and 67% had improved with mild disease activity (decrease in PCDAI score by at least 10 points) at the end of the study. Systemic and social quality of life improved with naltrexone treatment (P=0.035).
conclusionsNaltrexone therapy seems safe with limited toxicity when given to children with Crohn's disease and may reduce disease activity.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.