Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis

Background: Low-dose naltrexone (LDN) may promote psychological well-being as well as generalized health especially in autoimmune disorders. The objective of this study is to assess the effect of LDN on the Quality of Life (QoL) of patients with relapsing—remitting and secondary progressive multiple sclerosis (MS) using the scales and composite scores of the MSQoL-54 questionnaire. Methods: A 17-week randomized, double-blind, placebo-controlled, parallel-group, crossover-design clinical trial was conducted in two universities. A total of 96 adult patients aged between 15 and 65 years with relapsing—remitting (RR) or secondary progressive (SP) clinically definite MS with disease duration longer than 6 months enrolled into the study. The primary outcome of the study was comparison of the scores of physical and mental health by conducting independent t-test of the results obtained in the middle and at the end of study between the two groups. Results: Variables including presence of pain, energy, emotional well-being, social, cognitive, and sexual functions, role limitation due to physical and emotional problems, health distress, and overall QoL did not show any meaningful statistically difference between the two groups. Factor analysis revealed that health perception scores were statistically different between the groups before starting, in the middle, and at the end of the study. Conclusion: The study clearly illustrates that LDN is a relatively safe therapeutic option in RRMS and SPMS but its efficacy is under question and probably a long duration trial is needed in the future.

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Effects of Low-Dose Naltrexone on Quality of Life in High-Grade Glioma Patients: A Placebo-Controlled, Double-Blind Randomized Trial

10.21203/rs.3.rs-172964/v1 ◽

2021 ◽

Author(s):

Katherine B Peters ◽

Mary L Affronti ◽

Sarah Woodring ◽

Eric Lipp ◽

Patrick Healy ◽

...

Keyword(s):

Quality Of Life ◽

Radiation Therapy ◽

Functional Assessment ◽

Low Dose ◽

High Grade Glioma ◽

Concurrent Chemotherapy ◽

High Grade ◽

Double Blind ◽

Low Dose Naltrexone

Abstract Purpose: At diagnosis and throughout the disease course, patients with high-grade glioma (HGG) experience a diminished quality of life (QOL) and increased fatigue. Naltrexone, an orally semisynthetic opiate antagonist, is FDA-approved for the treatment of heroin/alcohol addiction, and low dose naltrexone (LDN) has been observed to improve QOL and lower fatigue in other neurological illnesses, such as multiple sclerosis. LDN is believed to function as a partial agonist and can lead to shifts in neurochemicals that reduce fatigue. Based on this, we sought to study whether LDN has an impact on QOL and fatigue in patients with HGG. Methods: In a placebo-controlled, double-blind study, we randomized 110 HGG patients to receive placebo (N=56) or LDN 4.5 mg orally at night (N=54). Subjects received LDN or placebo at day 1 of concurrent radiation and temozolomide therapy and continued for 16 weeks. Change from baseline in patient-reported outcomes of QOL (Functional Assessment of Cancer Therapy-Brain) and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) was assessed. Results: Demographics were WHO grade IV (85%), male (56%), KPS 90-100 (51%), grossly resected (55%), and mean age of 56 years. QOL and fatigue changes between baseline and post concurrent chemotherapy and radiation therapy were not significantly different between patients receiving LDN or placebo. The adverse event profile for LDN and placebo were similar and attributed to concomitant use of temozolomide. Conclusions: While safe to administer, LDN has no effect on QOL and fatigue in HGG patients during concurrent chemotherapy and radiation therapy. United States National Library of Medicine Clinical Trials.gov NCT01303835, Date 2/25/2011

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Quality of Life in Hematologic Cancer Patients: A Randomized Clinical Trial of Low Dose Naltrexone Versus Placebo

American Journal of Applied Sciences ◽

10.3844/ajassp.2008.872.875 ◽

2008 ◽

Vol 5 (7) ◽

pp. 872-875 ◽

Cited By ~ 2

Author(s):

Mohammad Ali Seifrabiei ◽

Mohammad Abbasi ◽

Ali Montazeri ◽

Fatemeh Shahnazari ◽

Arash Pooya

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Cancer Patients ◽

Low Dose ◽

Hematologic Cancer ◽

Low Dose Naltrexone

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Prurigo excoriée treated with low dose naltrexone

BMJ Case Reports ◽

10.1136/bcr-2021-243773 ◽

2021 ◽

Vol 14 (11) ◽

pp. e243773

Author(s):

Leonard Timoney ◽

Christopher B Bunker

Keyword(s):

Quality Of Life ◽

Brain Tumour ◽

Low Dose ◽

Treatment Approach ◽

Beneficial Impact ◽

History Of ◽

Modal Treatment ◽

Low Dose Naltrexone ◽

Systemic Agents

A 53-year-old woman presented with a 25-year history of acne excoriée and prurigo excoriée. Her symptoms began in 1988 coinciding with her husband’s death from a brain tumour when she was 27. The pruritus affected her quality of life and disturbed her sleep. She had scarring on her face and body resulting from persistent scratching. The pruritus proved refractory to treatment despite a multi-modal treatment approach including multiple topicals, phototherapy and systemic agents such as isotretinoin, antibiotics, anxiolytic agents and neuromodulators. She was extremely frustrated that various treatments had been ineffective at controlling the itch-scratch cycle. She was commenced on low dose naltrexone (LDN), 3 mg nocte, and she became itch free within a few weeks. She reports that the LDN has had a beneficial impact on her quality of life.

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Pharmacology Update: Low-Dose Naltrexone as a Possible Nonopioid Modality for Some Chronic, Nonmalignant Pain Syndromes

American Journal of Hospice and Palliative Medicine® ◽

10.1177/1049909119838974 ◽

2019 ◽

Vol 36 (10) ◽

pp. 907-912 ◽

Cited By ~ 2

Author(s):

Diana Trofimovitch ◽

Steven J. Baumrucker

Keyword(s):

Quality Of Life ◽

Pain Management ◽

Adverse Effects ◽

Palliative Medicine ◽

Low Dose ◽

Comfort Care ◽

Off Label ◽

Nonmalignant Pain ◽

Low Dose Naltrexone

Pain can have a devastating effect on the quality of life of patients in palliative medicine. Thus far, majority of research has been centered on opioid-based pain management, with a limited empirical evidence for the use of nonopioid medications in palliative care. However, opioid and nonopioid medications such as nonsteroidal anti-inflammatory drugs have their limitations in the clinical use due to risk of adverse effects, therefore, there is a need for more research to be directed to finding an alternative approach to pain management in comfort care setting. The purpose of this article is to discuss a potential new drug that would adequately alleviate pain and enhance quality of life without significant risks of adverse effects that would limit its use. Naltrexone is a reversible competitive antagonist at μ-opioid and κ-opioid receptors, which when used at standard doses of 50 to 150 mg was initially intended for use in opioid and alcohol use disorders. However, it was discovered that its use in low doses follows alternate pharmacodynamic pathways with various effects. When used in doses of 1 to 5 mg it acts as a glial modulator with a neuroprotective effect via inhibition of microglial activation. It binds to Toll-like receptor 4 and acts as an antagonist, therefore inhibiting the downstream cellular signaling pathways that ultimately lead to pro-inflammatory cytokines, therefore reducing inflammatory response. Its other mode of action involves transient opioid receptor blockade ensuing from low-dose use which upregulates opioid signaling resulting in increased levels of endogenous opioid production, known as opioid rebound effect. Low dose naltrexone has gained popularity as an off-label treatment of several autoimmune diseases including multiple sclerosis and inflammatory bowel disease, as well as chronic pain disorders including fibromyalgia, complex regional pain syndrome, and diabetic neuropathy. Low-dose naltrexone (LDN) may also have utility in improving mood disorders and the potential to enhance the quality of life. This article will therefore propose the potential off-label use of LDN in management of nonmalignant pain in the palliative medicine setting.

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Low-dose naltrexone for disease prevention and quality of life

Medical Hypotheses ◽

10.1016/j.mehy.2008.06.048 ◽

2009 ◽

Vol 72 (3) ◽

pp. 333-337 ◽

Cited By ~ 49

Author(s):

Norman Brown ◽

Jaak Panksepp

Keyword(s):

Quality Of Life ◽

Disease Prevention ◽

Low Dose ◽

Low Dose Naltrexone

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A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis

Multiple Sclerosis Journal ◽

10.1177/1352458508095828 ◽

2008 ◽

Vol 14 (8) ◽

pp. 1076-1083 ◽

Cited By ~ 51

Author(s):

M Gironi ◽

F Martinelli-Boneschi ◽

P Sacerdote ◽

C Solaro ◽

M Zaffaroni ◽

...

Keyword(s):

Multiple Sclerosis ◽

Adverse Events ◽

Low Dose ◽

Receptor Gene ◽

Pilot Trial ◽

Progressive Multiple Sclerosis ◽

Primary Progressive Multiple Sclerosis ◽

Mrna Levels ◽

Primary Progressive ◽

Low Dose Naltrexone

A sixth month phase II multicenter-pilot trial with a low dose of the opiate antagonist Naltrexone (LDN) has been carried out in 40 patients with primary progressive multiple sclerosis (PPMS). The primary end points were safety and tolerability. Secondary outcomes were efficacy on spasticity, pain, fatigue, depression, and quality of life. Clinical and biochemical evaluations were serially performed. Protein concentration of β-endorphins (BE) and mRNA levels and allelic variants of the μ-opiod receptor gene (OPRM1) were analyzed. Five dropouts and two major adverse events occurred. The remaining adverse events did not interfere with daily living. Neurological disability progressed in only one patient. A significant reduction of spasticity was measured at the end of the trial. BE concentration increased during the trial, but no association was found between OPRM1 variants and improvement of spasticity. Our data clearly indicate that LDN is safe and well tolerated in patients with PPMS.

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