- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Journal, Biopsy: Low-Dose Naltrexone Use in Biopsy-Proven Lichen Planus of the Nails. (Pubmed Central) - Oct 30, 2024
The results of this study suggest that low-dose naltrexone may be a therapeutic approach for treating nail lichen planus. Further controlled studies are warranted to better understand its clinical efficacy and safety profile in treating nail lichen planus.
- |||||||||| Lodonal (naltrexone low dose oral) / Biostax Corp, Statera BioPharma
Enrollment status: LDN-CRPS: Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome (clinicaltrials.gov) - Oct 17, 2024
P4, N=40, Enrolling by invitation,
Further controlled studies are warranted to better understand its clinical efficacy and safety profile in treating nail lichen planus. Recruiting --> Enrolling by invitation
- |||||||||| 2R,6R-hydroxynorketamine hydrochloride ((2R,6R)-HNK) / National Institute of Mental Health, methionine enkephalin (STAT-401) / Immune Therap, Statera BioPharma, Envelta (enkephalin intranasal) / Virpax Pharma
Journal: Ketamine and major ketamine metabolites function as allosteric modulators of opioid receptors. (Pubmed Central) - Oct 17, 2024
opioid receptors; this metabolite is known to have analgesic and antidepressant activity but does not bind to glutamate receptors...Significance Statement We found that ketamine and its major biologically-active metabolites function as potent allosteric modulators of mu, delta, and kappa opioid receptors, with submicromolar concentrations of these compounds synergizing with endogenous opioid peptides such as enkephalin and dynorphin. This allosteric activity may contribute to ketamine's therapeutic effectiveness for treating acute and chronic pain and as a fast-acting antidepressant drug.
- |||||||||| methionine enkephalin (STAT-401) / Immune Therap, Statera BioPharma
Journal: Dioxythiophene/Nafion Polymer Composite Membranes for Tunable Size-Based Selectivity in the Voltammetric Detection of Small Neuropeptides. (Pubmed Central) - Sep 25, 2024
The dioxythiophene/Nafion modified electrodes were characterized in the voltammetric detection of dopamine, a classic small molecule neurotransmitter, and a series of tyrosine containing neuropeptides of increasing size: met-enkephalin (M-ENK; 5 residues), oxytocin (OXY; 9 residues), neurotensin (NT; 13 residues), and neuropeptide Y (NPY; 36 residues). The modified electrodes exhibited enhanced selectivity for smaller peptide species over larger peptides in a manner consistent with the size of the dioxythiophene monomer incorporated into the polymeric film, allowing for tunability in terms of size-based selective detection.
- |||||||||| naltrexone / Generic mfg.
Clinical, Review, Journal: The use of naltrexone in the treatment of chronic pain: a systematic review. (Pubmed Central) - Sep 21, 2024
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.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Trial completion date, Trial primary completion date: Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy (clinicaltrials.gov) - Sep 20, 2024
P2, N=35, Recruiting,
However, further research with larger sample sizes and standardized methodologies is necessary. Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
- |||||||||| doxorubicin hydrochloride / Generic mfg.
Journal: Targeting OGF/OGFR Signal to Mitigate Doxorubicin-induced Cardiotoxicity. (Pubmed Central) - Sep 10, 2024
This study revealed a substantial increase in circulating levels of opioid growth factor (OGF) (also known as methionine enkephalin) and myocardial expression levels of both OGF and its receptor (OGFR) in subjects treated with doxorubicin (Dox)...Conversely, OGF supplementation exacerbated DIC manifestations, which could be abolished by administration of the OGFR antagonist naltrexone (NTX)...The pretreatment of tumor-bearing mice with the assembled NTX nanodrug successfully provided cardioprotection against Dox toxicity without affecting Dox therapy in tumors. Taken together, this study provides a novel understanding of Dox cardiotoxicity and sheds light on the development of cardioprotectants for patients with tumors receiving Dox treatment.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Journal: Alcohol use disorder in the perioperative period: a summary and recommendations for anesthesiologists and pain physicians. (Pubmed Central) - Sep 2, 2024
This review highlights key considerations for the anesthesiologist and pain physician in the perioperative management of patients with active AUD (or those in recovery). It discusses the effects of acute and chronic alcohol use on pain perception and thresholds, provides guidance on the perioperative management of naltrexone and low-dose naltrexone, and reviews a multimodal approach to pain management.
- |||||||||| naltrexone / Generic mfg.
Journal: Off-Label Use of Naltrexone in Pica and Other Compulsive Behaviors: A Report of Two Cases. (Pubmed Central) - Sep 2, 2024
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.
- |||||||||| famotidine / Generic mfg., cetirizine oral / Generic mfg.
Trial termination: Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial (clinicaltrials.gov) - Aug 21, 2024
P3, N=5, Terminated,
These effects of naltrexone were further bolstered by the effects that occurred when both patients discontinued naltrexone for some time. Completed --> Terminated; Study was terminated due to lack of funding.
- |||||||||| naltrexone / Generic mfg.
Lose-Dose Naltrexone to Treat Post-Herpetic Neuralgia in an Elderly Patient (Exhibit Hall) - Aug 6, 2024 - Abstract #ASA2024ASA_5034;
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.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Multimodal Management of the Impact of Long Covid on a Patient with Fibromyalgia (Exhibit Hall) - Aug 6, 2024 - Abstract #ASA2024ASA_4581;
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.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Enrollment change, Trial withdrawal: The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging (clinicaltrials.gov) - Aug 5, 2024
P=N/A, N=0, Withdrawn,
She was started on low-dose naltrexone and received bilateral stellate ganglion blocks with significant improvement in all pain symptoms and overall functional ability. N=2500 --> 0 | Suspended --> Withdrawn
- |||||||||| Dupixent (dupilumab) / Sanofi, Regeneron
Dupilumab in the Treatment of Hailey-Hailey Disease: A Case Report (Poster Area) - Aug 5, 2024 - Abstract #EADV2024EADV_3627;
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.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Topical Steroid Withdrawal: A Modern Phenomenon with Historical Roots (Poster Area) - Aug 5, 2024 - Abstract #EADV2024EADV_1863;
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
- |||||||||| methionine enkephalin (STAT-401) / Immune Therap, Statera BioPharma
Preclinical, Journal: CBD Versus CBDP: Comparing In Vitro Receptor-Binding Activities. (Pubmed Central) - Jul 31, 2024
To provide a structural explanation for the observed PAM effect, we conducted molecular docking simulations. These simulations revealed the co-binding potential of CBDP (or CBD) and met-enkephalin to the MOR.
- |||||||||| methionine enkephalin (STAT-401) / Immune Therap, Statera BioPharma
Preclinical, Journal: Effects of Pain Relief Through Minimal Exercise Intervention in a Rat Model of Neuropathic Pain. (Pubmed Central) - Jul 24, 2024
In the brain, we examined the increased expression of ?-endorphin/met-enkephalin in the gray matter of the midbrain aqueduct...In the midbrain, the Ex group showed a significant increase compared to the No-Ex group. In summary, our results suggest that in minimal-exercise intervention, neuropathic pain relief is achieved by activation of the descending pain inhibitory system in the midbrain.
- |||||||||| Dupixent (dupilumab) / Sanofi, Regeneron
Journal: Treatment of Recalcitrant Hailey-Hailey Disease With Naltrexone and Dupilumab: A Report of Two Cases. (Pubmed Central) - Jul 22, 2024
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.
- |||||||||| methionine enkephalin (STAT-401) / Immune Therap, Statera BioPharma
Journal: Modulation of endogenous opioid signaling by inhibitors of puromycin-sensitive aminopeptidase. (Pubmed Central) - Jul 10, 2024
In vivo treatment with the lead compound 19 caused significantly reduced pain response in antinociception assays, alone and in combination with Met-enkephalin...We gained additional insight into inhibitor-PSA interactions by molecular modeling, which underscored the importance of bulky aromatic amino acid in puromycin scaffold. The results of this study strongly support our rationale for the development of PSA inhibitors for effective pain management.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Review, Journal: Long COVID management: a mini review of current recommendations and underutilized modalities. (Pubmed Central) - Jul 1, 2024
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.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
PN120. Fibromyalgia, Nociplastic Pain, and Central Sensitization: Anesthetic Considerations (111AB) - Jun 25, 2024 - Abstract #ASA2024ASA_708;
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
- |||||||||| famotidine / Generic mfg., cetirizine oral / Generic mfg.
Enrollment closed, Enrollment change: Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial (clinicaltrials.gov) - Jun 24, 2024
P3, N=5, Active, not recruiting,
Learning Objective 3 Create an anesthetic plan to optimally manage individuals with nociplastic pain, central sensitivity, and/or fibromyalgia in the perioperative period Recruiting --> Active, not recruiting | N=36 --> 5
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Enrollment open, Trial initiation date: Low Dose Naltrexone for the treatment of long COVID-19 (EUDRACT) - Jun 21, 2024
P1, N=56, Recruiting,
Recruiting --> Active, not recruiting | N=36 --> 5 Not yet recruiting --> Recruiting
- |||||||||| methionine enkephalin (STAT-401) / Immune Therap, Statera BioPharma
Preclinical, Journal: Enkephalin Rescues Temporomandibular Joint Pain-Related Behavior in Rats. (Pubmed Central) - Jun 14, 2024
These experimental studies establish a basis for the use of replication-defective herpes simplex type 1-based gene therapy for severe chronic inflammatory temporomandibular joint destruction and pain. As innovative means of significantly reducing joint inflammation and preserving tissue architecture, gene therapies may extend their clinical usefulness for patients with temporomandibular joint disorders.
- |||||||||| methionine enkephalin (STAT-401) / Immune Therap, Statera BioPharma, Envelta (enkephalin intranasal) / Virpax Pharma
Journal: Organization of enkephalinergic neuronal system in the central nervous system of the gecko Hemidactylus frenatus. (Pubmed Central) - Jun 13, 2024
The enkephalinergic fibers were also seen in the area X around the central canal, as well as the dorsal and ventral horns. The widespread distribution of enkephalin-containing neurons within the central nervous system implies that enkephalins regulate a variety of functions in the gecko, including sensory, behavioral, hypophysiotropic, and neuroendocrine functions.
- |||||||||| Lodonal (naltrexone low dose oral) / Biostax Corp, Statera BioPharma
Enrollment open: LDN-CRPS: Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome (clinicaltrials.gov) - Jun 12, 2024
P4, N=40, Recruiting,
The widespread distribution of enkephalin-containing neurons within the central nervous system implies that enkephalins regulate a variety of functions in the gecko, including sensory, behavioral, hypophysiotropic, and neuroendocrine functions. Not yet recruiting --> Recruiting
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Journal: Low-dose naltrexone extends healthspan and lifespan in C. (Pubmed Central) - May 27, 2024
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.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Trial completion date, Trial primary completion date: Low Dose Naltrexone Use in Patients With POTS (clinicaltrials.gov) - May 9, 2024
P4, N=80, Not yet recruiting,
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. Trial completion date: Dec 2026 --> Dec 2028 | Trial primary completion date: Jun 2026 --> Jun 2028
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Faculty (258ABC - BCEC) - May 5, 2024 - Abstract #ENDO2024ENDO_2087;
To highlight some of the most prominent conditions and potentially dangerous treatments, we will discuss adrenal fatigue, Wilsons syndrome, reverse T3 syndrome, low testosterone in men and women without diagnostic testing, and low-dose naltrexone therapy. We will also discuss other conditions that are commonly misdiagnosed as disorders of the endocrine system such as pseudo-Cushing
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
MTP21. Pseudo-Endocrine Disorders: Recognition and Management (258ABC - BCEC) - May 5, 2024 - Abstract #ENDO2024ENDO_2086;
To highlight some of the most prominent conditions and potentially dangerous treatments, we will discuss adrenal fatigue, Wilsons syndrome, reverse T3 syndrome, low testosterone in men and women without diagnostic testing, and low-dose naltrexone therapy. We will also discuss other conditions that are commonly misdiagnosed as disorders of the endocrine system such as pseudo-Cushing
- |||||||||| Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap, methionine enkephalin (STAT-401) / Immune Therap, Statera BioPharma
Journal: Pre-proenkephalin 1 is Downregulated Under Unloading and is Involved in Osteoblast Biology. (Pubmed Central) - Apr 30, 2024
Interestingly, primary osteoblasts isolated from Penk1-/- mice showed lower metabolic activity, ALP activity, and nodule mineralization, as well as a lower number of CFU-F compared to osteoblasts isolated from WT mice, suggesting that, unlike the transient inhibition, the chronic Penk1 deletion affects both osteoblast differentiation and activity. Taken together, these results highlight a role for Penk1 in the regulation of the response of the bone to mechanical unloading, potentially acting on osteoblast differentiation and activity in a cell-autonomous manner.
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Enrollment open, Trial completion date, Trial primary completion date: Low Dose Naltrexone for Pain in Patients With HIV (clinicaltrials.gov) - Apr 30, 2024
P4, N=60, Recruiting,
Taken together, these results highlight a role for Penk1 in the regulation of the response of the bone to mechanical unloading, potentially acting on osteoblast differentiation and activity in a cell-autonomous manner. Suspended --> Recruiting | Trial completion date: Mar 2024 --> Jun 2025 | Trial primary completion date: Mar 2024 --> Jun 2025
- |||||||||| Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
Enrollment closed, Trial primary completion date, HEOR: INNOVA: Cost-utility and Physiological Effects of LDN in Patients With Fibromyalgia (clinicaltrials.gov) - Apr 22, 2024
P4, N=99, Active, not recruiting,
Suspended --> Recruiting | Trial completion date: Mar 2024 --> Jun 2025 | Trial primary completion date: Mar 2024 --> Jun 2025 Enrolling by invitation --> Active, not recruiting | Trial primary completion date: Jul 2023 --> Oct 2024
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