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Clinical Trials in Progress

Cost-utility and Physiological Effects of LDN in Patients With Fibromyalgia

Purpose of the Study: The study's purpose is to evaluate the effectiveness and safety of LDN in patients with fibromyalgia and analyse its cost-utility both from the government and the healthcare perspective at 12 months follow-up. Brain metabolites and systemic inflammatory biomarkers will be included to evaluate neurobiological mechanisms behind LDN therapeutic effects.
Study Start Date: July 01, 2021
Location: Parc Sanitari Sant Joan de Déu, Barcelona, Spain

Phase 2 Trial to Evaluate Safety and Efficacy of CYTO-205 in Mild COVID-19

Purpose of the Study: The aim of the study is to assess the safety and clinical efficacy of low-dose naltrexone in reducing the proportion of higher risk patients who progress from mild COVID-19 to a more severe disease category.
Study Start Date: April 01, 2021
Location: Cytocom, Inc.

Impact of Colchicine and Low-dose Naltrexone on COVID-19

Purpose of the Study: The purpose of this study is to explore the impact of low-dose naltrexone (LDN) and colchicine on COVID-19 disease progression in patients hospitalized with moderate COVID-19. Researchers have suggested that a hyperinflammatory response is involved in severe/critical cases of COVID-19. Given LDN acts both to boost the immune system and limit an excessive response, and colchicine has demonstrated clinical utility in inflammatory syndromes, they may prove useful in minimizing the risk of disease progression and associated adverse sequelae.
Study Start Date: January 25, 2021
Location: HealthPartners Institute, Park Nicollet Foundation, Saint Paul, Minnesota

Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy

Purpose of the Study: The goal of this randomized, placebo-controlled trial is to determine if LDN is effective for treating the pain caused by diabetic neuropathy. LDN's mechanism of action is well suited to treating painful diabetic neuropathy, and LDN shows significant promise as a safe, non-opioid alternative that can decrease pain and improve quality of life for those suffering from this painful condition.
Study Start Date: December 22, 2020
Location: Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA

Psychobiological Mechanisms Underlying Chronic Pain

Purpose of the Study: The aim of this study is to investigate the psychobiological mechanisms underlying the negative hedonic shift in chronic pain with a focus on the causal role of neuroinflammation (substudy 1) and the role of dopamine (substudy 2) in functional connectivity of fronto-striatal brain networks and their relation to heightened emotional-motivational pain processing. The drugs that will be used in both substudies will not be utilized as therapeutic clinical interventions, but as modulators of endogenous process and to assess psychobiological mechanisms in pain processing. Substudy 1 incorporates a 12-weeks a pharmacological intervention (low-dose naltrexone or placebo) in patients with fibromyalgia.
Study Start Date: December 19, 2020
Location: Balgrist University Hospital, Zürich, Switzerland

Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome

Purpose of the Study: This study will assess the use of low dose naltrexone (LDN) and NAD+ for the treatment of patients with post-COVID-19 syndrome (long-COVID-19). Patients will receive LDN and NAD+ treatment for 12 weeks, or will be followed up for 12 weeks (control group). Fatigue and quality of life will be assessed using validated surveys and improvement of scores from baseline levels will be assessed.
Study Start Date: November 10, 2020
Location: AgelessRx, Ann Arbor, Michigan, USA

Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19

Purpose of the Study: Study into the effects of daily use of metformin and low-dose naltrexone (LDN) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19.
Study Start Date: November 02, 2020
Location: AgelessRx, Ann Arbor, Michigan, USA

IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone, a Randomized Placebo-controlled Prospective Trial

Purpose of the Study: Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating condition with symptoms of urinary urgency, frequency, nocturia (waking up at night to void), and pain, without evidence of urinary tract infection or other identifiable causes. LDN has demonstrated improvement of symptoms in conditions associated with IC/PBS. The investigators' hypothesis is that LDN will have greater than 30% reduction in symptoms as defined by the Interstitial Cystitis Symptom Index in patients diagnosed with IC/PBS from baseline when compared to placebo.
Study Start Date: September 01, 2020
Location: NorthShore University HealthSystem, Chicago, Illinois, USA

Low-dose Naltrexone for Bladder Pain Syndrome

Purpose of the Study: Interstitial cystitis/Bladder Pain Syndrome (IC/PBS) is a constellation of symptoms of pelvic discomfort that includes both bladder-related pain as well as urinary frequency, urgency, and nocturia in the absence of an identifiable etiology that affects likely more than 5.4 million patients in the United States. There is a significant overlap in patients with IC/PBS and those with fibromyalgia and chronic pelvic pain syndrome. Low-dose naltrexone (LDN) has been shown to be effective for the treatment of chronic pain conditions. The primary aim of this study is to evaluate if LDN improves pain scores and lower urinary tract symptoms in patients with IC/PBS. A secondary aim is to show that it has a low adverse event profile.
Study Start Date: June 16, 2020
Location: Stanford University, Stanford, California, USA

Fibromyalgia and Naltrexone: The FINAL Study (FINAL)

Purpose of the Study: This study evaluates the effect of low dose naltrexone (LDN) on pain in women with fibromyalgia (FM). The study is designed as a parallel randomized (1:1) double blind, placebo-controlled superiority trial. Half of the participants will receive treatment with LDN while the other half will receive treatment with placebo. Low dose naltrexone (LDN) is used widely as off label treatment in patients with fibromyalgia, despite the lack of larger randomized controlled trials (RCT) supporting an effect. LDN has antagonistic effect on both opioid receptors and on toll-like receptors in glia cells. Mediated via those receptors, LDN can potentially reduce neuro inflammation and induce homeostasis in the endorphin system in patients with fibromyalgia. The aim of the trial is to investigate whether treatment with LDN has a superior effect compared to placebo on pain among female patients with fibromyalgia, evaluated after 12 weeks of treatment. The study is also exploring secondary aims regarding a possible improvement of other fibromyalgia core symptoms and a possible improvement of global assessment, daily functioning and health-related quality of life. Among the exploratory secondary objectives are changes in muscle exhaustion, physical fitness, pain sensitivity, inhibition of pain, augmentation of pain, and pro-inflammatory cytokines.
Study Start Date: May 01, 2020
Location: Odense University Hospital, University of Southern Denmark, University Hospital Bispebjerg and Frederiksberg, Denemark

Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

Purpose of the Study: Naltrexone is an FDA approved drug (for alcoholism) that has found widespread use "off-label" to treat pain and improve quality of life at much lower doses than are used for the approved indication. There are a few scientific studies in three conditions (fibromyalgia, Crohn's disease, and multiple sclerosis) that suggest that this drug has benefit and is safe. However, considering the extent of use in other conditions, and uncertainty about the mechanism of action study is needed in a diverse set of diseases, including vasculitis. The purpose of this clinical trial is to determine if low dose naltrexone is effective in improving health-related quality of life (HRQoL) among patients with vasculitis.
Study Start Date: March 29, 2018
Location: University of Pennsylvania, Philadelphia, USA

Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome (LDN-CRPS)

Purpose of the Study: The investigators are testing treatment with low-dose Naltrexone (LDN) for symptom relief of complex regional pain syndrome (CRPS). Study participants will be randomly assigned to receive either LDN (4.5 mg once daily) or placebo for a period of several weeks. During this period participants will be asked to come to several visits, which will include sensory testing, physical assessments, and questionnaires.
Study Start Date: June 01, 2015
Location: Palo Alto, California, USA

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