Clinical Trials/Research

There have been many trials and studies carried out on Low Dose Naltrexone. Below you will find a list of published papers. This list of clinical trials has been repurposed from, and was originally compiled by, LDN Research Trust.

At the bottom of this page are several anecdotal surveys, including two which were conducted by LDNers.org.

1991

1. Naltrexone and Other Potential New Pharmacological Treatments of Autism,” Jaak Panksepp, Patrick Lensing, Marion Leboyer, Manuel P. Bouvard, Brain Dysfunct 1991: 4:281-300

1995

2. Bovard, et al. Low-dose naltrexone effects on plasma chemistries and clinical symptoms in autism: a double-blind-placebo controlled study Psychiatry Research 58: 191-20, 1995 1989

3. J Am Acad Child Adolesc Psychiatry. 1989 Mar;28(2):200-6. Naltrexone in autistic children: an acute open dose range tolerance trial. Campbell M, Overall JE, Small AM, Sokol MS, Spencer EK, Adams P, Foltz RL, Monti KM, Perry R, Nobler M, et al.

1996

4. Ann 1st Super Sanita. 1996;32(3):351-9, Scifo R, Cioni M, Nicolosi A, Batticane N, Tirolo C, Testa N, Quattropani MC, Morale MC, Gallo F, Marchetti: “Opioid-immune interactions in autism: behavioural and immunological assessment during a double-blind treatment with naltrexone.

2002

5. Neuroimmunotherapy of untreatable metastatic solid tumors with subcutaneous low-dose interleukin-2, melatonin and naltrexone: modulation of interleukin-2-induced antitumor immunity by blocking the opioid system. Lissoni P, Malugani F, Malysheva O, Kozlov V, Laudon M, Conti A, Maestroni G. Division of Radiation Oncology, S. Gerardo Hospital, 20052 Monza (Milan), Italy. Neuro Endocrinol Lett. 2002 Aug;23(4):341-4. PMID: 12080288

2005

6. Low dose naltrexone therapy in multiple sclerosis,” Y.P. Agrawal, Medical Hypotheses (2005) 64, 721-724

2006

7. Low-dose naltreoxone for the treatment of irritable bowel syndrome: a pilot study. Kariv R, Tiomny E, Grenshpon R, Dekel R, Waisman G, Ringel Y, Halpern Z. Department of Gastrointestinal and Liver Diseases, 6 Weizmann Street, Tel-Aviv, 64239, Israel. Dig Dis Sci. 2006 Dec;51(12):2128-33. PMID: 17080248

2007

8. Research on Neurodegeneration at NIEHS Suggests a Protective Naltrexone Role J.S. Hong, Ph.D., head of the Neuropharmacology Section of the Laboratory of Pharmacology and Chemistry at the National Institute of Environmental Health Sciences, finds that “morphinan” drugs, including naltrexone and naloxone, are able to reduce inflammatory reactions in microglia brain cells in animal studies. Such inflammation is believed to be central to the progressive neurodegenerative effects seen in disorders such as Parkinson’s disease and Alzheimer’s disease. Hong’s report, summarizing the role of microglia in inflammation-related neurodegeneration and the potential of therapy using morphinans, appears in a January 2007 issue of Nature Reviews Neuroscience [8(1):57-69].

9. Smith JP,Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS Low-dose naltrexone therapy improves active Crohn’s disease. Am J Gastroenterol. 2007 Apr;102(4):820-8. Epub 2007 Jan 11.

10. Reversal of signs and symptoms of a B-cell lymphoma in a patient using only low-dose naltrexone.Berkson BM, Rubin DM, Berkson AJ.Integrative Medical Center of New Mexico, Las Cruces, USA. Integr Cancer Ther. 2007 Sep;6(3):293-6.PMID: 17761642

2008

11. Low-dose naltrexone for disease prevention and quality of life.Brown N, Panksepp J. Med Hypotheses. 2009 Mar;72(3):333-7. doi: 10.1016/j.mehy.2008.06.048. Epub 2008 Nov 28.PMID: 19041189

12. Gironi M, Martinelli-Boneschi F, Sacerdote P, Solaro C, Zaffaroni M, Cavarretta R, Moiola L, Bucello S, Radaelli M, Pilato V, Rodegher M, Cursi M, Franchi S, Martinelli V, Nemni R, Comi G, Martino G. A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis. Mult Scler. 2008 Sep;14(8):1076-83

13. Journal of Immunotoxicology. 2008, Vol. 5, No. 2 , Pages 179-187 The Opioid Antagonist Naltrexone Improves Murine Inflammatory Bowel Disease Gail L. Matters, John F. Harms, Christopher McGovern, Leo Fitzpatrick, Anuj Parikh, Nicholas Nilo and Jill P. Smith

2009

14. Younger J, Mackey S. Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study. Pain Med. 2009 May-Jun;10(4):663-72. Epub 2009 Apr 22

15. Gilhooly TC Low-dose naltrexone as a treatment for multiple sclerosis British Journal of Neuroscience Nursing, Vol. 5, Iss. 11, 13 Nov 2009, pp 494

16. Endogenous opioids regulate expression of experimental autoimmune encephalomyelitis: a new paradigm for the treatment of multiple sclerosis.Zagon IS, Rahn KA, Turel AP, McLaughlin PJ.Exp Biol Med (Maywood). 2009 Nov;234(11):1383-92. doi: 10.3181/0906-RM-189. PMID: 19855075

2010

17. Revisiting the ALA/N (alpha-lipoic acid/low-dose naltrexone) protocol for people with metastatic and nonmetastatic pancreatic cancer: a report of 3 new cases. Berkson BM, Rubin DM, Berkson AJ.The Integrative Medical Center of New Mexico, Las Cruces, NM, USA. Integr Cancer Ther. 2009 Dec;8(4):416-22. PMID: 20042414 2010

18. Low Dose Naltrexone: Side Effects and Efficacy in Gastrointestinal Disorders. Ploesser J, Weinstock LB Md, Thomas E Pharmd.St. Louis College of Pharmacy, St. Louis, Missouri. Int J Pharm Compd. 2010 March/April;14(2):171-173. PMID: 23965429

19. Neurotherapeutics: The Journal of the American Society for Experimental NeuroTherapeutics. 2010 March 6.: 232Abstract #13: Low-DoseNaltrexone’s Tolerability and Effects in Fatigued Patients with Parkinson’s Disease: An Open-Label Study Thomas Guttuso Jr., Naomi Salins, David Lichter

20. Cree BA, Kornyeyeva E, Goodin DS Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis. Ann Neurol. 2010 Aug;68(2):145-50.

21. Sharafaddinzadeh N, Moghtaderi A, Kashipazha D, Majdinasab N, Shalbafan B. The effect of low-dose naltrexone on quality of life of patients with multiple sclerosis: a randomized placebo-controlled trial. Mult Scler. 2010 Aug;16(8):964-9. Epub 2010 Jun 9

22. Low-dose naltrexone for treatment of duodenal Crohn’s disease in a pediatric patient. Shannon A, Alkhouri N, Mayacy S, Kaplan B, Mahajan L. Department of Pediatric Gastroenterology, Cleveland Clinic Pediatric Institute, Cleveland, Ohio. Inflammatory Bowel Dis. 2010 Sep;16(9):1457. PMID: 20014017

23. Inhibition of DNA synthesis in mouse epidermis by topical imiquimod is dependent on opioid receptors. McLaughlin PJ, Rogosnitzky M, Zagon IS. Exp Biol Med (Maywood). 2010 Nov;235(11):1292-9. doi: 10.1258/ebm.2010.010203. PMID: 20975079

24. Drug Alcohol Depend. 2010 Oct 1;111(3):200-6. Epub 2010 Jun 12. Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: a randomized trial. Toll BA, White M, Wu R, Meandzija B, Jatlow P, Makuch R, O’Malley SS.

2011

25. ALSUntangled No. 8: Low dose naltrexone for ALS. ALSUntangled Group. Amyotroph Lateral Scler. 2011 Jan;12(1):76-8. PMID: 21174518

26. Prevention and diminished expression of experimental autoimmune encephalomyelitis by low dose naltrexone (LDN) or opioid growth factor (OGF) for an extended period: Therapeutic implications for multiple sclerosis. Rahn KA, McLaughlin PJ, Zagon IS. Brain Res. 2011 Mar 24;1381:243-53. doi: 10.1016/j.brainres.2011.01.036. Epub 2011 Jan 20. PMID: 21256121

27. Smith JP, Bingaman SI, Ruggiero F, Mauger DT, Mukherjee A, McGovern CO, Zagon IS. Therapy with the opioid antagonist naltrexone promotes mucosal healing in active Crohn’s disease: a randomized placebo-controlled trial.Dig Dis Sci. 2011 Jul;56(7):2088-97. Epub 2011 Mar 8.

28. Rahn KA, McLaughlin PJ, Zagon IS. Prevention and diminished expression of experimental autoimmune encephalomyelitis by low dose naltrexone (LDN) or opioid growth factor (OGF) for an extended period: Therapeutic implications for multiple sclerosis. Brain Res. 2011 Mar 24;1381:243-53. Epub 2011 Jan 20.

29. Low-dose naltrexone suppresses ovarian cancer and exhibits enhanced inhibition in combination with cisplatin.Donahue RN, McLaughlin PJ, Zagon IS. Exp Biol Med (Maywood). 2011 Jul;236(7):883-95. doi: 10.1258/ebm.2011.011096. Epub 2011 Jun 17. PMID: 21685240

30. Enhancing acupuncture by low dose naltrexone. Hesselink JM, Kopsky DJ. Institute for Neuropathic Pain, Soest, The Netherlands. jan@neuropathie.nu Acupunct Med. 2011 Jun;29(2):127-30. PMID: 21415049

31. Donahue RN,McLaughlin PJ,Zagon IS The opioid growth factor (OGF) and low dose naltrexone (LDN) suppress human ovarian cancer progression in mice. Gynecol Oncol. 2011 Aug;122(2):382-8. Epub 2011 Apr 30.

32. Low-dose naltrexone: tricking the body to heal itself. Exp Biol Med (Maywood). 2011 Sep 1;236(9):vii-viii.

33. Low-dose naltrexone for pruritus in systemic sclerosis. Frech T, Novak K, Revelo MP, Murtaugh M, Markewitz B, Hatton N, Scholand MB, Frech E, Markewitz D, Sawitzke AD. Division of Rheumatology, Department of Internal Medicine, University of Utah, Salt Lake City, UT 84132, USA. Int J Rheumatol. 2011;2011:804296. PMID: 21918649

34. Low-dose naltrexone for pruritus in systemic sclerosis. Frech T, Novak K, Revelo MP, Murtaugh M, Markewitz B, Hatton N, Scholand MB, Frech E, Markewitz D, Sawitzke AD.Int J Rheumatol. 2011;2011:804296. doi: 10.1155/2011/804296. Epub 2011 Sep 12. PMID: 21918649 [PubMed]

35. Journal of AIDS and HIV Research Vol. 3(10), pp. 189-198, October 2011 Impact of low dose naltrexone (LDN) on antiretroviral therapy (ART) treated HIV+ adults in Mali: A single blind randomized clinical trial Abdel K. Traore, Oumar Thiero, Sounkalo Dao, Fadia F. C. Kounde, Ousmane Faye, Mamadou Cisse, Jaquelyn B. McCandless, Jack M. Zimmerman, Karim Coulibaly, Ayouba Diarra, Mamadou S. Keita, Souleymane Diallo, Ibrahima G Traore and Ousmane Koita

2012

36. Journal of AIDS and HIV Research Vol. 3(10), pp. 180-188, October 2011 Single cohort study of the effect of low dose naltrexone on the evolution of immunological, virological and clinical state of HIV+ adults in Mali Abdel K. Traore, Oumar Thiero, Sounkalo Dao, Fadia F. C. Kounde, Ousmane Faye, Mamadou Cisse, Jaquelyn B. McCandless, Jack M. Zimmerman, Karim Coulibaly, Ayouba Diarra, Mamadou S. Keita, Souleymane Diallo, Ibrahima G Traore and Ousmane Koita 2012

37. Opioid growth factor (OGF) for hepatoblastoma: a novel non-toxic treatment. Rogosnitzky M, Finegold MJ, McLaughlin PJ, Zagon IS.Invest New Drugs. 2013 Aug;31(4):1066-70. doi: 10.1007/s10637-012-9918-3. Epub 2012 Dec 30.PMID: 23275062

2013

38. Smith JP, Field D, Bingaman SI, Evans R, Mauger DT. Safety and Tolerability of Low-dose Naltrexone Therapy in Children With Moderate to Severe Crohn’s Disease: A Pilot Study. J Clin Gastroenterol. 2012 Dec 13. [Epub ahead of print] 2013

39. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Younger J, Noor N, McCue R, Mackey S. Stanford University School of Medicine, Palo Alto, California 94304-1573, USA. Arthritis Rheum. 2013 Feb;65(2):529-38. PMID: 23359310

40. Safety and tolerability of low-dose naltrexone therapy in children with moderate to severe Crohn’s disease: a pilot study. Smith JP, Field D, Bingaman SI, Evans R, Mauger DT. Department of Medicine, College of Medicine, Pennsylvania State University, Hershey, PA Clin Gastroenterol. 2013 Apr;47(4):339-45. PMID: 23188075

41. Chopra P, Cooper MS. J Neuroimmune Pharmacol. 2013 Jun;8(3):470-6. doi: 10.1007/s11481-013-9451-y. Epub 2013 Apr 2. PMID: 23546884 [PubMed – in process] Treatment of Complex Regional Pain Syndrome (CRPS) using low dose naltrexone (LDN). Chopra P, Cooper MS. Department of Medicine, Alpert Medical School of Brown University, 102 Smithfield Ave, Pawtucket, RI 02860, USA. J Neuroimmune Pharmacol. 2013 Jun;8(3):470-6. PMID: 23546884

42. Opioid growth factor (OGF) for hepatoblastoma: a novel non-toxic treatment. Rogosnitzky M, Finegold MJ, McLaughlin PJ, Zagon IS.MedInsight Research Institute, Invest New Drugs. 2013 Aug;31(4):1066-70. PMID: 23275062

Surveys

LDNers.org Survey #1

Conducted by LDNers.org. Completed July 12, 2004. View as PDF

Relapse rate, symptoms and disease progression reported by this sample of 267 LDN users. Key finding is a very low relapse rate of 0.2, or 1 in 5 years. Detailed records are available upon request.

In addition to the above linked PDF, feel free to view SammyJo’s slideshow presentation, presented at the first-ever LDN Conference in 2005.

LDNers.org Survey #2

Conducted by LDNers.org. Completed mid-2005. View as PDF

This survey tracks the change in disability before and after LDN for 157 respondents to the survey.

LDN Research Trust Survey (Ongoing)

If you are a current or past user of Low Dose Naltrexone, consider participating in this ongoing survey. All the anecdotal evidence will be collated and presented in a statistical format to help gain funding and support from the medical profession. Eminent Neurologist Dr Alasdair Coles, from Addenbrookes hospital in Cambridge has given his approval and consent to this survey. Complete the online survey form, click “send” and it will go directly to the LDN Research Trust. The LDN Research Trust will not pass your details on to a third party for any purpose whatsoever.