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

Perioperative Management of the Patient on Low Dose Naltrexone (LDN) (ASA 2025) - "There is no abstract associated with this presentation."

Clinical • Addiction (Opioid and Alcohol) • Anesthesia • Pain

Use of low-dose naltrexone in the management of post-traumatic trigeminal neuropathic pain: a retrospective case series. (PubMed, Quintessence Int) - "Based on our retrospective extended case series, LDN appears to be a safe and effective medication for use in chronic PTTNP. These results, highlight the need for future studies to elucidate LDN's analgesic mechanism of actions and to decisively demonstrate the analgesic effect of LDN in larger cohorts using randomized, double blinded, placebo controlled clinical studies."

Journal • Retrospective data • CNS Disorders • Epilepsy • Musculoskeletal Diseases • Neuralgia • Pain

Low Dose Naltrexone In The Management Of Chronic Pain Syndrome: A Meta-Analysis Of Randomized Controlled Clinical Trials. (PubMed, Curr Pain Headache Rep) - "LDN is better than placebo in fibromyalgia pain management, and LDN is similar to active controls in chronic pain management."

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

Effects of low-dose naltrexone on salience network connectivity in major depressive disorder (CINP-AsCNP 2025) - "These preliminary results indicate that LDN increases connectivity between the right AI and right pSTG relative to placebo in MDD. The pSTG contains the auditory cortex, potentially indicating increased connectivity between the SN and auditory network following LDN treatment. Enhanced connectivity between these regions may resemble greater sensory input to the SN, which could confer more effective attribution of salience with treatment."

CNS Disorders • Depression • Inflammation • Major Depressive Disorder • Mood Disorders • Psychiatry

Low-Dose Naltrexone for Severe Fibromyalgia Syndrome: A Report of a Case With Two-Year Follow-Up. (PubMed, Cureus) - "While some patients with FMS respond to standard treatment with amitriptyline, pregabalin, or duloxetine in combination with outpatient multimodal pain management, there are still many who do not benefit sufficiently from this treatment or suffer intolerable side effects. The results of this case report suggest that an off-label use of LDN in severe refractory FMS may be a viable option. However, the information base is currently limited, and studies are conflicting."

Journal • CNS Disorders • Cognitive Disorders • Fatigue • Fibromyalgia • Musculoskeletal Diseases • Musculoskeletal Pain • Pain • Rheumatology • Sleep Disorder

Low-Dose naltrexone restored TRPM3 ion channel function in natural killer cells from long COVID patients. (PubMed, Front Mol Biosci) - "There was no significant difference in TRPM3 currents between long COVID patients treated with LDN and healthy controls (HC), in either PregS-induced current amplitude (p > 0.9999) or resistance to ononetin (p > 0.9999). Overall, our findings support LDN as a potentially beneficial treatment for long COVID patients by restoring TRPM3 ion channel function and reestablishing adequate Ca2+ influx necessary for homeostatic cellular processes."

Journal • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • TRPM3

LDN-CRPS: Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: Stanford University | Trial completion date: Jun 2025 ➔ Jul 2027 | Trial primary completion date: Jun 2025 ➔ Jul 2027

Trial completion date • Trial primary completion date • Musculoskeletal Pain • Pain

Naltrexone dose-selectively modulates goal-directed behavior and the hypothalamic proteome in rats. (PubMed, Pharmacol Rep) - "Different doses of naltrexone had varying effects on motivational measures and the rat's hypothalamic proteome. Naltrexone 0.1 mg/kg impaired motivational directedness and effort-based decision-making that corresponds to reduced reward signaling due to opioid blockade. In contrast, LDN enhanced vigor, but only early in the treatment. Naltrexone had no effects on the POMC-dependent endogenous opioid pathway, suggesting that a different mechanism underlies its motivational effects."

Journal • Preclinical • Addiction (Opioid and Alcohol) • POMC-null Obesity

Long COVID, Longer Recovery: Multimodal and Integrative Approaches to the Evaluation and Management of Long COVID in Mental Health Settings (APA 2025) - "Management of symptoms such as pain, fatigue and brain fog will be discussed, including psychological and behavioral interventions such as mind-body therapies and activity pacing as well as integrative medicine approaches such as supplements, medications like low dose naltrexone and lifestyle modifications. Innovative treatments under investigation will be reviewed along with accessible resources, tips and tools to equip general mental health practitioners with a variety of ways to help patients suffering from long COVID. Instructional Level Introductory; Learning Objectives Objective One: Discuss steps to evaluation of long COVID symptoms in psychiatric settings Objective Two: Review treatment approaches for common psychiatric symptoms of long COVID including mood changes, anxiety and medical trauma Objective Three: Identify pharmacological, psychological/behavioral and integrative approaches to management of long COVID symptoms such as fatigue, pain and brain fog..."

CNS Disorders • Fatigue • Infectious Disease • Insomnia • Mood Disorders • Novel Coronavirus Disease • Pain • Psychiatry • Sleep Disorder

Dual blockade of TLR-4 and mu-opioid receptor by very low-dose naltrexone prevents respiratory depression via modulating redox homeostasis and airway inflammation in chronic obstructive pulmonary disease. (PubMed, Cell Signal) - "The study also delved into intricate pathway where mechanistically VLDN exerted anti-inflammatory effect by inhibiting the activation of NF-kB/MAPK signalling via TLR4. These findings collectively highlight VLDN multifaceted impact in mitigating oxidative stress, inflammation influencing apoptosis in COPD management, offering valuable insights for future therapeutic strategies."

Journal • Addiction (Opioid and Alcohol) • Chronic Obstructive Pulmonary Disease • CNS Disorders • Depression • Immunology • Inflammation • Mood Disorders • Psychiatry • Pulmonary Disease • Respiratory Diseases • CASP3 • IFNG • IL6 • TLR4 • TNFA

Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Medical College of Wisconsin | Not yet recruiting ➔ Recruiting

Enrollment open • Central Neuropathic Pain • CNS Disorders • Neuralgia • Orthopedics • Pain

Efficacy and safety of low-dose naltrexone (LDN) in fibromyalgia: a systematic review and meta-analysis. (PubMed, Ann Med Surg (Lond)) - "No serious adverse effects were reported in treatment group. There is need for more RCTs to support the evidence."

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

NEUROPATHIC PRURITUS RELIEVED BY EPIDURAL STEROID INJECTION: A CASE REPORT (ASRA-SPRING 2025) - "The patient was initially treated by dermatology for presumed seborrheic keratoses or xerosis using topical steroids, moisturizers, and dupilumab, but these treatments were ineffective...Adjunct therapies, including gabapentin and low-dose naltrexone, provided sustained symptom relief with minimal side effects...Additionally, the integration of dermatological insights into diagnosis and treatment highlights the importance of interdisciplinary collaboration in achieving optimal outcomes. Further studies are warranted to explore this treatment modality in NP."

Case report • Clinical • Anesthesia • Dermatology • Inflammation • Pain • Pruritus • Sleep Disorder • Urology

Efficacy of Low-Dose Naltrexone in Treating Patients with Fibromyalgia: systematic Review and Meta-Analysis. (PubMed, J Pain Palliat Care Pharmacother) - "Although LDN marginally reduced pain and symptom severity from baseline, these effects were not superior to placebo. This suggests that LDN may not provide significant clinical benefit over placebo in fibromyalgia management, warranting further research."

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

Therapeutic Uses and Efficacy of Low-Dose Naltrexone: A Scoping Review. (PubMed, Cureus) - "The articles selected presented clinical examples of LDN efficacy for a variety of medical conditions. These articles also helped to illuminate the current gaps in research, pointing to the need for larger clinical trials and proper dosing studies."

Journal • Review • Fibromyalgia • Genetic Disorders • Inflammation • Musculoskeletal Pain • Pain • Rheumatology • Substance Abuse

LoDoNaVasc: Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: University of Pennsylvania | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Eosinophilic Granulomatosis With Polyangiitis • Giant Cell Arteritis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis

Effect of Naltrexone on Spinal and Supraspinal Pain Mechanisms and Functional Capacity in Women with Fibromyalgia: Exploratory Outcomes from the Randomized Placebo-Controlled FINAL Trial. (PubMed, CNS Drugs) - "We found a significant between-group difference in CPM change in favor of LDN. However, this difference was partly explained by a decrease in CPM in the placebo group. Sensitivity analyses showed no association between changes in CPM and clinical pain improvement, suggesting that the group-difference in CPM is a random finding."

Journal • Fatigue • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Low Dose Naltrexone for Treatment of Severe Hemochromatosis Pain (IARS-SOCCA 2025) - "Pharmacologically, he has tried various combinations of multimodal pain regimen—including acetaminophen, oxycodone, gabapentin, pregabalin, cyclobenzaprine, baclofen, tizanidine, carisoprodol, dexamethasone, and amitriptyline—with minimal to no pain relief...His current pain regimen includes LDN at 6 mg twice daily, gabapentin 900 mg three times daily, and duloxetine 60 mg daily... We present a patient with severe pain from hemochromatosis and arachnoiditis that was refractory to numerous interventions and medical treatments. Remarkably, noticeable pain improvement was achieved only with initiation of low-dose naltrexone (LDN). This case is noteworthy as there is no documented use of LDN specifically for hemochromatosis-associated pain and in this case it has been the only effective therapy trialed."

Anesthesia • CNS Disorders • Crohn's disease • Fatigue • Gastroenterology • Genetic Disorders • Hematological Disorders • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Multiple Sclerosis • Orthopedics • Pain • Rheumatology • Urinary Incontinence

Low-Dose Naltrexone Use in Pain Reduction for Dysautonomia Patients: A Case Series (AAN 2025) - "Through retrospective chart review it is seen that LDN therapy is largely tolerated and safe touse. Patients experienced minimal to no side effects, and based on this case study, LDNappeared to reduce the severity of pain in dysautonomia patients seen in our tertiary careautonomic center. Additional studies would be needed to show the effects of LDN in a largersample size to make results more generalizable."

Clinical • CNS Disorders • Fibromyalgia • Gastrointestinal Disorder • Insomnia • Migraine • Musculoskeletal Pain • Neuralgia • Pain • Rheumatology • Sleep Disorder

IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone (clinicaltrials.gov) - P4 | N=3 | Terminated | Sponsor: Endeavor Health | Completed ➔ Terminated; There was a delay in recruitment initiation due to COVID-19 and internal logistical challenges. Following this delay, the principal investigator left the study site, and it was determined that the study should be terminated.

Trial termination • Interstitial Cystitis • Musculoskeletal Pain • Pain

Unexpected Increase in Bone Mineral Density With Rapamycin and Low-Dose Naltrexone: A Case Report of a 52-Year-Old Woman With Osteopenia. (PubMed, Cureus) - "Osteopenia and osteoporosis are prevalent bone disorders characterized by reduced bone mineral density (BMD), leading to an increased risk of fractures. This case report presents a 52-year-old Caucasian female patient with osteopenia who experienced an unexpected 15.9% increase in lumbar spine BMD within two years after enrolling in a clinical trial involving low-dose rapamycin and subsequently starting low-dose naltrexone. This case potentially opens novel treatment strategies for bone density improvement in aging populations."

Journal • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Current and Evolving Concepts in the Management of Complex Regional Pain Syndrome: A Narrative Review. (PubMed, Diagnostics (Basel)) - "Additionally, there is ongoing debate regarding the efficacy of other treatments, such as free radical scavengers, alpha-lipoic acid (ALA), dimethyl fumarate (DMF), adenosine monophosphate-activated protein kinase (AMPK) activators such as metformin, and phosphodiesterase-5 inhibitors such as tadalafil. The controversies surrounding the mechanisms, diagnosis, and treatment of CRPS have prompted researchers to investigate new approaches aimed at enhancing understanding and management of the condition, with the goal of alleviating symptoms and reducing associated disabilities."

IO biomarker • Journal • Review • Musculoskeletal Pain • Pain • TLR4

LIFT: Life Improvement Trial (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Brigham and Women's Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2026 ➔ Nov 2026 | Trial primary completion date: Mar 2026 ➔ Sep 2026

Enrollment open • Trial completion date • Trial primary completion date

Low-Dose Naltrexone for Pediatric Chronic Pain and Inflammatory States: Perioperative Considerations. (PubMed, Paediatr Anaesth) - No abstract available

Journal • Pain • Pediatrics

Evaluation of Low-Dose Naltrexone for Chronic Pain Management. (PubMed, J Pain Palliat Care Pharmacother) - "Low-dose naltrexone was generally well-tolerated with 32% (13 of 41) of Veterans reporting adverse effects including vivid dreams, drowsiness, dizziness, and nausea. Low-dose naltrexone resulted in a small decrease in pain, although may be considered after a patient has failed multiple lines of therapy for additional pain control after a risk versus benefits discussion."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Fibromyalgia • Multiple Sclerosis • Musculoskeletal Pain • Pain • Rheumatology • Substance Abuse