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Clinical Trials in Progress

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

Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia

Purpose of the Study: Oral naltrexone was initially FDA approved to treat opioid use disorder and alcohol dependence at doses from 50-100mg/day. At lower doses of 1-5mg/day, naltrexone has been used off-label with success in treatment of several dermatologic conditions including the scarring hair loss disease lichen planopilaris. A recent case series of four patients with lichen planopilaris and a subtype, frontal fibrosing alopecia, treated with oral low-dose naltrexone at 3mg daily showed reduction of itch, clinical evidence of inflammation of the scalp, and of disease progression. There were no reported adverse events. Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued on their other medications for these conditions. The study would be open-label, so all participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 9 months to monitor their progress.
Study Start Date: June 01, 2020
Location: Washington University, Saint Louis, Missouri, 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

Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19 (SINK COVID-19)

Purpose of the Study: Ideal new treatments for Novel Coronavirus-19 (COVID-19) would help halt the progression disease in patients with mild disease prior to the need for artificial respiration (ventilators), and also provide a rescue treatment for patients with severe disease, while also being affordable and available in quantities sufficient to treat large numbers of infected people. Low doses of Naltrexone, a drug approved for treating alcoholism and opiate addiction, as well as Ketamine, a drug approved as an anesthetic, may be able to interrupt the inflammation that causes the worst COVID-19 symptoms and prove an effective new treatment. This study will investigate their effectiveness in a randomized, blinded trial versus standard treatment plus placebo. The trial will measure the ability of low dose naltrexone to reduce the progression of participants with COVID-19. In this study, naltrexone or placebo will be given to participants in early stages of COVID-19 infection in a randomized, double blinded manner, whereas the use of ketamine will be unblinded and given as a rescue agent should a participant progress. Additionally, should a participant be ineligible for the randomized portion of the study due to already being in a more advanced stage of the disease, they will be given the opportunity to enter the trial to receive ketamine without being randomized to naltrexone vs placebo. Participants will continue to receive any standard of care COVID-19 treatment during their participation in this study.
Study Start Date: April 28, 2020
Location: Beaumont Hospital, Royal Oak, Michigan, USA

St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin (UH3)

Purpose of the Study: Pain is a common co-morbidity for HIV-positive patients. Prevalence studies suggest that, on average, half of all HIV-positive persons suffer pain. Chronic pain can lead to heavy alcohol use among HIV-positive persons, which may in turn be a barrier to treatment/control of HIV and contribute to spread of HIV. Thus there is an urgent need to address pain among persons with HIV. It is timely and relevant to conduct research on gabapentin, as it has emerged as one of the most commonly prescribed non-opioid medications for pain despite the fact that gabapentin is only FDA approved for "post-herpetic neuralgia" and the literature to support its use for generalized chronic pain is limited. And yet, gabapentin has demonstrated benefits for treatment of alcohol use disorder, and therefore, like naltrexone, it could have a specific role for treating patients with chronic pain and unhealthy alcohol use. This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin vs. placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain (both self-reported and experimental/cold pressor test; 2) inflammation (i.e., levels of inflammatory cytokines IL-6 and TNF-α); and 3) measures of HIV control (CD4 count and viral load).
Study Start Date: April 01, 2020
Location: First St. Petersburg Pavlov State Medical University, St. Petersberg, Russia

Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis

Purpose of the Study: The purpose of this study is to determine if the addition of Low Dose Naltrexone to standard endometriosis treatments will improve patient reported endometriosis associated pain. The central hypothesis of the research study is that low dose naltrexone (LDN), in combination with hormonal suppression of endometriosis (standard of care), will lead to significant improvement of endometriosis-related pain. The proposal seeks to: 1) determine if the addition of LDN to standard endometriosis treatments will improve patient- reported endometriosis associated pain using daily Visual Analogue Scale (VAS) scores and 2) measure the impact of treatment on quality of life as measured by validated questionnaires including the Endometriosis Health Profile-30 (EHP30) and the Patient's Global Impression of Change (PGIC). The study involves a 12-week intervention period of 4.5 mg daily naltrexone (or placebo) in combination with standard treatment of 5 mg daily norethindrone acetate, and the use of scales to rate daily pain and quality of life.
Study Start Date: July 01, 2019
Location: Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA

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

Endogenous Modulation and Central Sensitization in New Daily Persistent Headache in Children

Purpose of the Study: The purpose of this study is to investigate low-dose naltrexone for the treatment of new daily persistent headache (NDPH) in adolescents ages 10-17. New daily persistent headache (NDPH) is a primary headache disorder with a reported prevalence of 3.5% in adolescents. Patients with NDPH have compromised academic performance, school absence, anxiety, depressed mood, sleep impairment, family disruption, and high health care costs. Little is known about which medications effectively manage and treat NDPH. One proposed medication that may benefit children and adolescents with NDPH is low-dose naltrexone. Naltrexone is an anti-inflammatory agent, similar to the opioid antagonist naloxone. Naltrexone is an effective treatment for opioid addiction, however, it was recently discovered that when taken in low doses (1/10 of the typical dose) naltrexone is capable of reducing the severity of chronic pain symptoms. By acting on glial cells in the nervous system as well as other receptors in the brain, naltrexone is capable of exerting analgesic effects. With this analgesic property, it has been speculated that low-dose naltrexone may be an effective treatment for the management of several chronic pain conditions, including headache.Although more research must be conducted to evaluate long-term effects of using low-dose naltrexone, prior studies show that there are little short-term consequences associated with using this drug as a form of treatment for chronic pain symptoms. Investigators aim to assess the efficacy and safety of low-dose naltrexone in the treatment of patients with NDPH. Adolescents ages 10-17 will be recruited from Boston Children's Hospital Pediatric Headache Program.
Study Start Date: March 02, 2018
Location: Boston Children’s Hospital, Boston, Massachusetts, USA

Low Dose Naltrexone for Chronic Pain in Arthritis

Purpose of the Study: Over 100 million Americans report chronic pain. Veterans are disproportionately affected for multiple reasons, including injuries and post-traumatic stress disorder. Treatment for chronic pain is a priority research area for the VA. One of the most common causes of chronic pain is osteoarthritis (OA). OA is attributable to "wear and tear," but reasons for pain are complex. Inflammatory arthritis (IA) includes multiple severe diseases that affect 2-3% of persons and require treatment with immune-suppressive drugs to prevent joint destruction. Pain often persists despite effective treatment. Pain in arthritis results from multiple sources: inflammation, perception of pain in the joint, and interpretation of pain by the brain. Unfortunately, management of pain in arthritis remains a challenge. Low dose naltrexone is a widely used but unproven "alternative" approach to chronic pain. It is attractive for study because it is safe and is proposed to work on all three pathways that contribute to pain. A small but high-quality clinical trial is needed to determine whether to invest in definitive studies.
Study Start Date: February 01, 2017
Location: VA Boston Healthcare System, Boston, Massachusetts, USA

Low Dose Naltrexone for Treatment of Pain in Patients With Fibromyalgia - Effect Via a Central Mechanism? (LDN-in-FM)

Purpose of the Study: This study evaluates the effect and mechanism of low dose naltrexone for treatment of pain in patients with fibromyalgia. It s a randomised, double-blinded, placebo-controlled, cross-over study.
Study Start Date: June 01, 2016
Location: Multidisciplinary Pain Clinic, Copenhagen & Give, Denmark

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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