Lodonal (naltrexone low dose oral) / Biostax Corp, Statera BioPharma - LARVOL DELTA

LDN-CRPS: Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome (clinicaltrials.gov) - P4 | N=40 | Enrolling by invitation | Sponsor: Hospital for Special Surgery, New York | Recruiting ➔ Enrolling by invitation

Enrollment status • Musculoskeletal Pain • Pain

Dupilumab in the Treatment of Hailey-Hailey Disease: A Case Report (EADV 2024) - "He underwent various previous therapies, including multiple cycles of antibiotics, botulinum toxin injection, acitretin, low-dose naltrexone, cyclosporine, topical corticosteroids, and topical calcineurin inhibitors with no significant response. Dupilumab has demonstrated efficacy in treating Hailey-Hailey disease, as shown in this case. Inhibition of IL-4 and IL-13 by dupilumab appears to modulate intracellular calcium signaling, correcting the defect present in this genodermatosis. Sharing cases like this one is crucial due to the rarity of the disease and the limited treatment options available, potentially expanding the use of dupilumab to other acantholytic disorders."

Case report • Clinical • Dermatology • Genetic Disorders • Pain • Pruritus • IL13 • IL4

Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis. (PubMed, Korean J Pain) - "LDN was also associated with higher incidence of vivid dreams and nausea, but showed no significant difference with the placebo in terms of serious adverse events, headache, diarrhea, and dizziness. This study suggests the efficacy of LDN in mitigating pain symptoms for fibromyalgia patients with a relatively good safety profile."

Journal • Retrospective data • Review • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Topical Steroid Withdrawal: A Modern Phenomenon with Historical Roots (EADV 2024) - "In Dermatology, low-dose naltrexone was widely touted on social media, including YouTube, as an anecdotal treatment for patients with Hailey-Hailey disease... Overall, further research is required to understand the mechanisms behind TSW. However, it is important to understand the origins of the phenomenon which is first described by patients. The rising use of social media and patient advocacy groups can lead to misinformation surrounding topical corticosteroids and subsequent ‘ corticophobia ’ ."

CNS Disorders • Dermatology • Fatigue • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Mood Disorders • Novel Coronavirus Disease • Pneumonia • Psychiatry • Respiratory Diseases

low dose naltrexone in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and long coronavirus disease (long COVID) symptoms (ANZCTR) - P1 | N=56 | Not yet recruiting | Sponsor: Griffith University

New P1 trial • CNS Disorders • Fatigue • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • TRPM3

The use of naltrexone in the treatment of chronic pain: a systematic review. (PubMed, Pain Manag) - "The results suggest that low-dose naltrexone is not effective in managing chronic pain and improving the quality of life in patients with diverse chronic pain conditions. However, further research with larger sample sizes and standardized methodologies is necessary."

Clinical • Journal • Review • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: Dartmouth-Hitchcock Medical Center | Trial completion date: Sep 2024 ➔ Sep 2025 | Trial primary completion date: Sep 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Diabetic Neuropathy • Pain

Diabetic Peripheral Neuropathy: Emerging Treatments of Neuropathic Pain and Novel Diagnostic Methods. (PubMed, J Diabetes Sci Technol) - "Skin biopsies, corneal confocal microscopy, transcutaneous electrical stimulation, blood-derived biomarkers, and multi-omics emerge as some of the most promising new techniques, while low-dose naltrexone, selective sodium-channel blockers, calcitonin gene-related peptide antibodies, and angiotensin type 2 receptor antagonists emerge as some of the most promising new drug candidates. Our review concludes that although several promising diagnostic modalities and emerging treatments exist, an ongoing need persists for the further development of sensitive diagnostic tools and mechanism-based, personalized treatment approaches."

Journal • Review • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Low Dose Naltrexone for Pediatric Chronic Pain and Inflammatory States: The Perioperative Conundrum (ASA 2024) - "We present a 12-year-old girl with Crohn's disease (LDN 4.5mg-qd) and cerebral palsy who underwent GETA for selective dorsal rhizotomy with neurosurgical in-situ epidural ropivacaine-duramorph. The acute pain service subsequently managed her with a ketamine infusion and multimodal adjuncts. Herein we highlight the µ-receptor modulations, opioid-sensitivity/resistance, and pharmacotherapy that can prove deleterious in perioperative pain control for pediatric patients on LDN; and offer a streamlined preoperative approach to maximize patient safety."

Clinical • Cerebral Palsy • CNS Disorders • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Pain • Pediatrics

Lose-Dose Naltrexone to Treat Post-Herpetic Neuralgia in an Elderly Patient (ASA 2024) - "Thus, low-dose naltrexone (LDN) (2.5 mg twice daily) was started with satisfactory pain relief. Our patient reported that after running out of her medication she required an increasing dose of ibuprofen to achieve comparable pain relief to LDN. In conclusion, LDN regimen may match the efficacy of moderate to high doses of NSAIDs and gabapentin for pain control for post-herpetic neuralgia."

Clinical • Neuralgia • Pain

Multimodal Management of the Impact of Long Covid on a Patient with Fibromyalgia (ASA 2024) - "She had inadequate pain relief with medication management of her localized neck and head pain with trigger point injections and occipital nerve blocks. She was started on low-dose naltrexone and received bilateral stellate ganglion blocks with significant improvement in all pain symptoms and overall functional ability."

Clinical • Fatigue • Fibromyalgia • Infectious Disease • Musculoskeletal Pain • Neuralgia • Novel Coronavirus Disease • Pain • Rheumatology

PN120. Fibromyalgia, Nociplastic Pain, and Central Sensitization: Anesthetic Considerations (ASA 2024) - "Pharmacological agents used to manage fibromyalgia can include pregabalin, duloxetine, dietary and nutritional supplements, and often low-dose naltrexone and buprenorphine or even cannabinoids and psilocybins. Learning Objective 2 Identify pharmacological agents typically utilized in the management of fibromyalgia and nociplastic pain conditions and their implications in the perioperative period.. Learning Objective 3 Create an anesthetic plan to optimally manage individuals with nociplastic pain, central sensitivity, and/or fibromyalgia in the perioperative period"

Anesthesia • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Off-Label Use of Naltrexone in Pica and Other Compulsive Behaviors: A Report of Two Cases. (PubMed, Cureus) - "The introduction of naltrexone resulted in significant improvements, including decreased pica symptoms and improvements in depression, anxiety, and overall behaviors. These effects of naltrexone were further bolstered by the effects that occurred when both patients discontinued naltrexone for some time."

Journal • Autism Spectrum Disorder • CNS Disorders • Depression • Genetic Disorders • Mood Disorders • Psychiatry

Low-dose naltrexone in the perioperative period. (PubMed, Reg Anesth Pain Med) - No abstract available

Journal • Pain

The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: AgelessRx | N=2500 ➔ 0 | Suspended ➔ Withdrawn

Enrollment change • Trial withdrawal

Low-Dose Naltrexone as First Option for Fibromyalgia Patients: A Case Series. (PubMed, Isr Med Assoc J) - No abstract available

Journal • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Treatment of Recalcitrant Hailey-Hailey Disease With Naltrexone and Dupilumab: A Report of Two Cases. (PubMed, Cureus) - "The findings suggest that Th2 blockade with dupilumab, in conjunction with naltrexone, effectively controls recalcitrant HHD, indicating a role of cytokine response in altering disease pathogenesis. This case contributes to the growing body of literature on biologic treatments for HHD and suggests avenues for further research in HHD management."

Journal • Genetic Disorders

Potential pathophysiological role of the ion channel TRPM3 in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and the therapeutic effect of low-dose naltrexone. (PubMed, J Transl Med) - "We propose that TRPM3 dysfunction may have a broader involvement in ME/CFS pathophysiology, affecting other organs. This paper discusses TRPM3's expression in various organs and its potential impact on ME/CFS symptoms, with a focus on small nerve fibers and the brain, where TRPM3 is involved in presynaptic GABA release."

Journal • Review • Cardiovascular • CNS Disorders • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain • TRPM3

Long COVID management: a mini review of current recommendations and underutilized modalities. (PubMed, Front Med (Lausanne)) - "The purpose of this mini review is to provide primary care providers with the latest highlights from existing literature regarding the most common long COVID symptoms and current management recommendations. This review also highlights the underutilized interventions of stellate ganglion blocks and low-dose naltrexone, both with well-established safety profiles demonstrated to improve quality of life and functionality for patients suffering with some symptoms of long COVID, and encourages prompt referral to interventional pain management."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Low Dose Naltrexone for the treatment of long COVID-19 (ANZCTR) - P1 | N=56 | Recruiting | Sponsor: Griffith University | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2024

Enrollment open • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Colchicine and/or Naltrexone for Hospitalized COVID-19 Patients Not Requiring High Levels of Ventilatory Support (COLTREXONE): A Prospective, Randomized, Open-Label Trial. (PubMed, Cureus) - "We assessed the efficacy and safety of colchicine and low-dose naltrexone (LDN), alone and in combination, in preventing progression to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Diarrhea was the most common adverse reaction. In adults hospitalized with SARS-CoV-2 not requiring high-level ventilatory support, colchicine and LDN, alone and in combination, were not associated with significant reductions in progression to severe disease."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

LDN-CRPS: Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Hospital for Special Surgery, New York | Not yet recruiting ➔ Recruiting

Enrollment open • Musculoskeletal Pain • Pain

A Utilization Review of Patients That Respond to Low-Dose Naltrexone (LDN) for Chronic Pain at a Single Institution. (PubMed, J Pain Palliat Care Pharmacother) - "This retrospective review demonstrated that LDN may be an effective modality for some chronic pain indications. Reported pain scores were significantly lower at initial follow up compared to baseline for the total population, and for patients with fibromyalgia (FM) specifically."

Journal • Review • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Longitudinal Progression of Patients with Long COVID Treated in a Post-COVID Clinic: A Cross-Sectional Survey. (PubMed, J Prim Care Community Health) - "The patients rated numerous interventions as being helpful, including low-dose naltrexone (45/77; 58%), vagal nerve stimulation (18/34; 53%), and fisetin (28/44; 64%). Patients report general improvements in symptoms following the initial LCC visit, but complete recovery rates remain low at 23.2 ± 6.4 months."

Journal • Cardiovascular • CNS Disorders • Fatigue • Fibromyalgia • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Rheumatology

Low-dose naltrexone extends healthspan and lifespan in C. elegans via SKN-1 activation. (PubMed, iScience) - "This effect was mediated through SKN-1 (NRF2 in mammals) signaling, influencing innate immune gene expression and upregulating oxidative stress responses. With LDN's low side effects profile, our findings underscore its potential as a geroprotector, suggesting further exploration for promoting healthy aging in humans is warranted."

Journal