{"id":"oral-naltrexone","safety":{"commonSideEffects":[{"rate":"10-15","effect":"Nausea"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Anxiety"},{"rate":"5-10","effect":"Insomnia"},{"rate":"5-10","effect":"Abdominal pain"},{"rate":"5-10","effect":"Joint and muscle pain"},{"rate":null,"effect":"Hepatotoxicity (at high doses)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Naltrexone competitively binds to opioid receptors (mu, delta, and kappa) and prevents opioid agonists from activating these receptors. This mechanism is used to reduce cravings and block the rewarding effects of opioids in opioid use disorder, and has also been studied for other conditions including alcohol use disorder and chronic pain when combined with low-dose naltrexone (LDN) formulations.","oneSentence":"Oral naltrexone is an opioid receptor antagonist that blocks the effects of opioids and endogenous opioid peptides in the central nervous system.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:58:47.802Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Opioid use disorder (maintenance treatment)"},{"name":"Alcohol use disorder"},{"name":"Opioid overdose reversal (acute use)"}]},"trialDetails":[{"nctId":"NCT07249554","phase":"PHASE2","title":"Combination Therapy for Alcohol Use Disorder","status":"NOT_YET_RECRUITING","sponsor":"Johns Hopkins University","startDate":"2026-05","conditions":"Alcohol Use Disorder","enrollment":45},{"nctId":"NCT06500793","phase":"PHASE1","title":"Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)","status":"RECRUITING","sponsor":"Ensysce Biosciences","startDate":"2024-11-24","conditions":"Pharmacokinetics","enrollment":30},{"nctId":"NCT07224009","phase":"PHASE2","title":"Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)","status":"NOT_YET_RECRUITING","sponsor":"University of Arkansas","startDate":"2026-03","conditions":"Metastatic Prostate Cancer","enrollment":60},{"nctId":"NCT06233799","phase":"PHASE3","title":"Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder","status":"RECRUITING","sponsor":"National Institute on Drug Abuse (NIDA)","startDate":"2024-07-01","conditions":"Methamphetamine-dependence, Methamphetamine Abuse","enrollment":360},{"nctId":"NCT04276259","phase":"PHASE4","title":"Rapid Antidepressant Improvement Secondary to Excitatory Brain Responses","status":"COMPLETED","sponsor":"Marta Peciña, MD PhD","startDate":"2020-10-19","conditions":"Major Depressive Disorder, Depression","enrollment":120},{"nctId":"NCT07285473","phase":"PHASE2","title":"Low-Dose Naltrexone For ME/CFS: Dose-Finding","status":"NOT_YET_RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2026-04-01","conditions":"Myalgic Encephalomyelitis/Chronic Fatigue Syndrome","enrollment":75},{"nctId":"NCT06845124","phase":"PHASE2","title":"A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence","status":"RECRUITING","sponsor":"Central Institute of Mental Health, Mannheim","startDate":"2025-07-22","conditions":"Alcohol Addiction, Alcoholism","enrollment":150},{"nctId":"NCT03482479","phase":"PHASE2","title":"Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2019-02-04","conditions":"Eosinophilic Granulomatosis With Polyangiitis (EGPA), Churg-Strauss Syndrome (CSS), Giant Cell Arteritis","enrollment":60},{"nctId":"NCT05579249","phase":"PHASE4","title":"A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2023-01-19","conditions":"Obesity","enrollment":500},{"nctId":"NCT06098079","phase":"PHASE4","title":"Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)","status":"RECRUITING","sponsor":"Currax Pharmaceuticals","startDate":"2024-01-03","conditions":"Obesity","enrollment":8600},{"nctId":"NCT07269873","phase":"PHASE1","title":"Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol","status":"NOT_YET_RECRUITING","sponsor":"BioCorRx Pharmaceuticals Inc","startDate":"2026-01-13","conditions":"Healthy Adult Male and Female Volunteers","enrollment":30},{"nctId":"NCT05509257","phase":"EARLY_PHASE1","title":"Naltrexone Neuroimaging in Teens With Eating Disorders","status":"RECRUITING","sponsor":"Children's Mercy Hospital Kansas City","startDate":"2022-09-17","conditions":"Eating Disorders, Binge Eating, Purging (Eating Disorders)","enrollment":60},{"nctId":"NCT05748639","phase":"PHASE2, PHASE3","title":"Integrated Digital Intervention for Alcohol Use Disorder","status":"COMPLETED","sponsor":"Quit Genius","startDate":"2023-01-01","conditions":"Alcohol Use Disorder","enrollment":242},{"nctId":"NCT07132177","phase":"PHASE2","title":"Targeted Naltrexone to Support Individuals Participating in Dry January","status":"RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2025-11-03","conditions":"Alcohol Misuse","enrollment":20},{"nctId":"NCT07221565","phase":"PHASE1, PHASE2","title":"Quantum-Synaptic Immunotherapy Mapping Using Low-Frequency Electromagnetic Resonance and Machine Learning-Based Cytokine Forecasting","status":"ENROLLING_BY_INVITATION","sponsor":"Truway Health, Inc.","startDate":"2025-10-23","conditions":"Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis","enrollment":120},{"nctId":"NCT04791969","phase":"PHASE2","title":"Intermittent Oral Naltrexone Enhanced With an Ecological Momentary Intervention for Methamphetamine-using MSM","status":"COMPLETED","sponsor":"Glenn-Milo Santos","startDate":"2021-12-14","conditions":"Methamphetamine Use Disorder","enrollment":60},{"nctId":"NCT07188545","phase":"","title":"Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ohio State University","startDate":"2025-09-15","conditions":"Cardiovascular Kidney Metabolic Syndrome","enrollment":23280000},{"nctId":"NCT05968690","phase":"PHASE1","title":"Naltrexone and Propranolol Combined With Immunotherapy","status":"RECRUITING","sponsor":"Sarah Weiss","startDate":"2023-09-11","conditions":"Advanced Melanoma","enrollment":12},{"nctId":"NCT06374290","phase":"PHASE1","title":"Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia","status":"TERMINATED","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2024-07-16","conditions":"Smoking Cessation","enrollment":2},{"nctId":"NCT04817410","phase":"PHASE1","title":"ED Initiated Oral Naltrexone for AUD","status":"COMPLETED","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2021-09-28","conditions":"Alcohol Use Disorder","enrollment":30},{"nctId":"NCT05073679","phase":"PHASE2, PHASE3","title":"Oral Naltrexone In Pediatric Eating Disorders","status":"TERMINATED","sponsor":"Rosemary Claire Roden","startDate":"2022-04-22","conditions":"Anorexia Nervosa/Bulimia, Anorexia in Adolescence, Anorexia Nervosa, Atypical","enrollment":9},{"nctId":"NCT06809166","phase":"PHASE4","title":"Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity","status":"RECRUITING","sponsor":"The Royal's Institute of Mental Health Research","startDate":"2024-07-04","conditions":"Obesity, Weight Loss, Weight Management","enrollment":40},{"nctId":"NCT05537935","phase":"PHASE4","title":"Low Dose Naltrexone for Pain in Patients With HIV","status":"RECRUITING","sponsor":"Emory University","startDate":"2023-04-28","conditions":"Human Immunodeficiency Virus, Chronic Neuropathic Pain","enrollment":60},{"nctId":"NCT06090461","phase":"","title":"Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.)","status":"COMPLETED","sponsor":"Currax Pharmaceuticals","startDate":"2014-09","conditions":"Obesity","enrollment":31889},{"nctId":"NCT06140420","phase":"PHASE4","title":"Naltrexone for Prolonged Grief Disorder","status":"TERMINATED","sponsor":"Texas Tech University","startDate":"2023-08-01","conditions":"Naltrexone HCl 50 MG Oral Tablet, Placebo","enrollment":7},{"nctId":"NCT05827159","phase":"PHASE3","title":"Emergency Department-Initiated Medications for Alcohol Use Disorder","status":"RECRUITING","sponsor":"Yale University","startDate":"2024-08-17","conditions":"Alcohol Use Disorder","enrollment":240},{"nctId":"NCT04219540","phase":"PHASE4","title":"Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2021-01-07","conditions":"Opioid-use Disorder","enrollment":675},{"nctId":"NCT04678895","phase":"PHASE2","title":"Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy","status":"RECRUITING","sponsor":"Dartmouth-Hitchcock Medical Center","startDate":"2020-12-22","conditions":"Painful Diabetic Neuropathy","enrollment":35},{"nctId":"NCT06104280","phase":"","title":"Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment","status":"RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2025-01-06","conditions":"Opioid Use Disorder, Sleep Disturbance","enrollment":200},{"nctId":"NCT05007561","phase":"EARLY_PHASE1","title":"Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences","status":"RECRUITING","sponsor":"San Diego State University","startDate":"2021-11-16","conditions":"Naltrexone, Placebo","enrollment":210},{"nctId":"NCT04313972","phase":"PHASE4","title":"IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone","status":"TERMINATED","sponsor":"Endeavor Health","startDate":"2021-09-07","conditions":"Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome","enrollment":3},{"nctId":"NCT05304364","phase":"PHASE1","title":"Safety, Tolerability, and Pharmacokinetics of Naltrexone Implant (DLP-160)","status":"COMPLETED","sponsor":"Delpor, Inc.","startDate":"2022-03-22","conditions":"Opiod Use Disorder","enrollment":10},{"nctId":"NCT05092841","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of PXT3003 in Charcot-Marie-Tooth Type 1A","status":"COMPLETED","sponsor":"Tasly GeneNet Pharmaceuticals Co., Ltd","startDate":"2021-09-28","conditions":"Charcot-Marie-Tooth Type 1A","enrollment":176},{"nctId":"NCT05940324","phase":"PHASE2","title":"Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)","status":"RECRUITING","sponsor":"Stanford University","startDate":"2024-02-24","conditions":"Obsessive-Compulsive Disorder","enrollment":150},{"nctId":"NCT03718104","phase":"","title":"MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study","status":"COMPLETED","sponsor":"Boston Medical Center","startDate":"2018-12-01","conditions":"Opioid-use Disorder, Neonatal Abstinence Syndrome, Pregnancy, High Risk","enrollment":46},{"nctId":"NCT01950520","phase":"PHASE2","title":"Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate","status":"COMPLETED","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","startDate":"2014-02-07","conditions":"Healthy Volunteers","enrollment":47},{"nctId":"NCT02454712","phase":"PHASE1","title":"Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)","status":"COMPLETED","sponsor":"Ensysce Biosciences","startDate":"2016-11-16","conditions":"Healthy","enrollment":64},{"nctId":"NCT05043766","phase":"PHASE1","title":"Evaluation of Oral PF614 Relative to OxyContin (PF614-102)","status":"COMPLETED","sponsor":"Ensysce Biosciences","startDate":"2021-09-08","conditions":"Healthy Volunteers","enrollment":84},{"nctId":"NCT04531176","phase":"PHASE4","title":"EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial","status":"TERMINATED","sponsor":"The Cleveland Clinic","startDate":"2020-09-01","conditions":"Type 2 Diabetes, Obesity","enrollment":74},{"nctId":"NCT04218240","phase":"PHASE2","title":"Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2020-12-17","conditions":"Opioid Withdrawal","enrollment":90},{"nctId":"NCT04547985","phase":"PHASE4","title":"Naltrexone Treatment for Prolonged Grief Disorder (PGD)","status":"TERMINATED","sponsor":"Weill Medical College of Cornell University","startDate":"2021-01-05","conditions":"Prolonged Grief Disorder","enrollment":9},{"nctId":"NCT06426303","phase":"PHASE4","title":"Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder","status":"RECRUITING","sponsor":"Milky Kohno","startDate":"2024-05-02","conditions":"Alcohol Use Disorder","enrollment":100},{"nctId":"NCT04480554","phase":"PHASE2","title":"Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1","status":"RECRUITING","sponsor":"University of Pennsylvania","startDate":"2023-01-30","conditions":"Opioid-use Disorder, HIV-1-infection, Immune Activation","enrollment":225},{"nctId":"NCT04762758","phase":"PHASE3","title":"Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pharnext S.C.A.","startDate":"2021-03-30","conditions":"Charcot-Marie-Tooth Disease","enrollment":350},{"nctId":"NCT05093296","phase":"PHASE2, PHASE3","title":"Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use Disorder","status":"COMPLETED","sponsor":"Central Institute of Mental Health, Mannheim","startDate":"2021-12-02","conditions":"Alcohol Use Disorder, Alcoholism, Alcohol Addiction","enrollment":62},{"nctId":"NCT03023540","phase":"PHASE3","title":"Assessing Long Term Safety and Tolerability of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A","status":"UNKNOWN","sponsor":"Pharnext S.C.A.","startDate":"2017-03-07","conditions":"Charcot-Marie-Tooth Disease, Type IA","enrollment":187},{"nctId":"NCT06175507","phase":"NA","title":"Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.","status":"UNKNOWN","sponsor":"Institute of Liver and Biliary Sciences, India","startDate":"2023-12-25","conditions":"Alcohol Liver Disease","enrollment":110},{"nctId":"NCT04553263","phase":"EARLY_PHASE1","title":"Relapse Prevention in Stimulant Use Disorder","status":"WITHDRAWN","sponsor":"University of California, Los Angeles","startDate":"2023-06-11","conditions":"Stimulant Use, Relapse, Cognitive Function","enrollment":""},{"nctId":"NCT04762537","phase":"NA","title":"Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2021-03-16","conditions":"Opioid-use Disorder","enrollment":415},{"nctId":"NCT04589130","phase":"PHASE4","title":"Evaluating Contrave for Weight Maintenance in Adults With BMI >= 27 Kg/m2, After 6 Month Behaviour Modification Program.","status":"UNKNOWN","sponsor":"St. Joseph's Healthcare Hamilton","startDate":"2021-02-01","conditions":"Obesity","enrollment":89},{"nctId":"NCT04587843","phase":"PHASE4","title":"A Trial Evaluating the Effectiveness of Contrave in Patients Who Have Weight Recidivism Following Bariatric Surgery","status":"UNKNOWN","sponsor":"St. Joseph's Healthcare Hamilton","startDate":"2021-04-01","conditions":"Obesity","enrollment":18},{"nctId":"NCT04756128","phase":"PHASE2","title":"Impact of Colchicine and Low-dose Naltrexone on COVID-19","status":"COMPLETED","sponsor":"HealthPartners Institute","startDate":"2021-01-25","conditions":"Covid19","enrollment":142},{"nctId":"NCT05955313","phase":"PHASE2","title":"Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia","status":"RECRUITING","sponsor":"Medical University of Lublin","startDate":"2023-05-31","conditions":"Vulvodynia, Naltrexone, Quality of Life","enrollment":300},{"nctId":"NCT03374956","phase":"PHASE3","title":"Individualized Obesity Pharmacotherapy","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2017-12-11","conditions":"Obesity","enrollment":193},{"nctId":"NCT05087771","phase":"PHASE4","title":"In Hospital IM Naltrexone: A Pilot Study","status":"WITHDRAWN","sponsor":"University of Colorado, Denver","startDate":"2022-03","conditions":"Alcohol Use Disorder","enrollment":""},{"nctId":"NCT04391764","phase":"NA","title":"Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis.","status":"COMPLETED","sponsor":"Institute of Liver and Biliary Sciences, India","startDate":"2020-12-06","conditions":"Liver Cirrhosis","enrollment":100},{"nctId":"NCT00775229","phase":"PHASE2","title":"Naltrexone in the Treatment of Trichotillomania","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2008-08","conditions":"Trichotillomania","enrollment":51},{"nctId":"NCT02268448","phase":"PHASE1","title":"Treatment of Chronic Itch in Atopic Dermatitis (Eczema): Nerve Function","status":"COMPLETED","sponsor":"University of Minnesota","startDate":"2015-07","conditions":"Cutaneous Nerves CNS Itch","enrollment":8},{"nctId":"NCT04604704","phase":"PHASE2","title":"Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome","status":"COMPLETED","sponsor":"AgelessRx","startDate":"2021-01-28","conditions":"Covid19, Long COVID-19, Post-COVID-19 Syndrome","enrollment":36},{"nctId":"NCT04270877","phase":"PHASE2","title":"Fibromyalgia and Naltrexone: The FINAL Study","status":"COMPLETED","sponsor":"Odense University Hospital","startDate":"2021-01-06","conditions":"Fibromyalgia","enrollment":99},{"nctId":"NCT03799198","phase":"PHASE4","title":"Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2019-01-07","conditions":"Obesity","enrollment":200},{"nctId":"NCT03232346","phase":"PHASE3","title":"A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2017-08-01","conditions":"Opioid-use Disorder","enrollment":11},{"nctId":"NCT03970330","phase":"PHASE3","title":"Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis","status":"TERMINATED","sponsor":"Milton S. Hershey Medical Center","startDate":"2020-01-16","conditions":"Endometriosis","enrollment":9},{"nctId":"NCT04139213","phase":"PHASE2, PHASE3","title":"Medication Maintenance Therapy in Community Pharmacy Settings","status":"UNKNOWN","sponsor":"Lifespan","startDate":"2019-07-25","conditions":"Opioid-use Disorder","enrollment":250},{"nctId":"NCT02543944","phase":"PHASE2, PHASE3","title":"Improving Treatment Outcomes for Prescription Opioid Dependence","status":"COMPLETED","sponsor":"University of Arkansas","startDate":"2016-02","conditions":"Drug Dependence","enrollment":117},{"nctId":"NCT02537197","phase":"PHASE1","title":"The Effect of Regular Naltrexone Dosing on Disordered Gamblers","status":"COMPLETED","sponsor":"University of Calgary","startDate":"2016-04","conditions":"Gambling","enrollment":35},{"nctId":"NCT03447782","phase":"PHASE1, PHASE2","title":"Endogenous Modulation and Central Sensitization in New Daily Persistent Headache ( NDPH ) in Children","status":"COMPLETED","sponsor":"Boston Children's Hospital","startDate":"2018-07-23","conditions":"New Daily Persistent Headache (NDPH)","enrollment":45},{"nctId":"NCT05002946","phase":"PHASE1","title":"Pharmacokinetics of SP-104","status":"COMPLETED","sponsor":"Scilex Pharmaceuticals, Inc.","startDate":"2022-01-11","conditions":"Healthy","enrollment":18},{"nctId":"NCT03113409","phase":"PHASE2, PHASE3","title":"Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol","status":"TERMINATED","sponsor":"New York State Psychiatric Institute","startDate":"2017-06-01","conditions":"Opioid-use Disorder","enrollment":10},{"nctId":"NCT05228418","phase":"PHASE4","title":"Bridging ED to Outpatient AUD Therapy With Naltrexone","status":"UNKNOWN","sponsor":"Albert Einstein Healthcare Network","startDate":"2022-03","conditions":"Alcohol Use Disorder","enrollment":20},{"nctId":"NCT04958876","phase":"PHASE1","title":"Study to Evaluate the Safety of SP-104","status":"COMPLETED","sponsor":"Scilex Pharmaceuticals, Inc.","startDate":"2021-10-04","conditions":"Healthy Volunteers","enrollment":52},{"nctId":"NCT04365985","phase":"PHASE2","title":"Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19","status":"TERMINATED","sponsor":"Corewell Health East","startDate":"2020-04-29","conditions":"COVID-19, Acute Respiratory Distress Syndrome, Severe Acute Respiratory Syndrome (SARS)","enrollment":70},{"nctId":"NCT04409041","phase":"PHASE2","title":"Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2019-09-01","conditions":"Lichen Planopilaris, Frontal Fibrosing Alopecia","enrollment":43},{"nctId":"NCT04056182","phase":"PHASE2","title":"Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2019-09-01","conditions":"Opioid-use Disorder","enrollment":20},{"nctId":"NCT01843023","phase":"PHASE4","title":"Extended Release Naltrexone for Opioid-Dependent Youth","status":"COMPLETED","sponsor":"Friends Research Institute, Inc.","startDate":"2013-06","conditions":"Drug Dependence","enrollment":288},{"nctId":"NCT01866098","phase":"NA","title":"Naltrexone for Antipsychotic-Induced Weight Gain","status":"COMPLETED","sponsor":"Yale University","startDate":"2013-05","conditions":"Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder","enrollment":144},{"nctId":"NCT03762798","phase":"NA","title":"Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone","status":"WITHDRAWN","sponsor":"The Cleveland Clinic","startDate":"2018-11-19","conditions":"Substance Use Disorders, Substance Abuse, Substance Use","enrollment":""},{"nctId":"NCT02478489","phase":"PHASE4","title":"Alcohol Disorder hOsPital Treatment Trial","status":"COMPLETED","sponsor":"Boston University","startDate":"2016-06","conditions":"Heavy Drinking, Alcohol Dependence, Alcohol Use Disorder","enrollment":248},{"nctId":"NCT03078075","phase":"PHASE3","title":"Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2017-05-05","conditions":"Methamphetamine Use Disorder","enrollment":403},{"nctId":"NCT01415895","phase":"PHASE2","title":"Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain","status":"COMPLETED","sponsor":"Annette C. Toledano MD","startDate":"2011-07","conditions":"Back Pain, Lower Back Pain, Cervical Pain","enrollment":78},{"nctId":"NCT04757506","phase":"NA","title":"An Investigation of the Effects of Opioid Receptor Blockade on Changes in Self-esteem and Social Attention","status":"COMPLETED","sponsor":"McGill University","startDate":"2012-07-09","conditions":"Self Esteem","enrollment":35},{"nctId":"NCT04575194","phase":"PHASE4","title":"Study of the Cardiometabolic Effects of Obesity Pharmacotherapy","status":"UNKNOWN","sponsor":"National and Kapodistrian University of Athens","startDate":"2020-09-08","conditions":"Obesity, Blood Pressure","enrollment":40},{"nctId":"NCT04502251","phase":"PHASE2, PHASE3","title":"LDN and tDCS in Fibromyalgia","status":"COMPLETED","sponsor":"Centro Universitario La Salle","startDate":"2018-08-01","conditions":"Fibromyalgia","enrollment":92},{"nctId":"NCT01893827","phase":"PHASE4","title":"Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2014-06","conditions":"Alcohol Dependence","enrollment":237},{"nctId":"NCT02978417","phase":"PHASE4","title":"Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings","status":"COMPLETED","sponsor":"Duke University","startDate":"2017-09-21","conditions":"Opioid-Related Disorders","enrollment":14},{"nctId":"NCT04322526","phase":"PHASE4","title":"Study of Naltrexone-Induced Blockade of Antidepressant Effects","status":"COMPLETED","sponsor":"Marta Peciña, MD PhD","startDate":"2017-07-01","conditions":"Depression, Major Depressive Disorder","enrollment":25},{"nctId":"NCT02294253","phase":"PHASE2, PHASE3","title":"Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2014-09","conditions":"Opioid Dependence","enrollment":30},{"nctId":"NCT04115020","phase":"PHASE2","title":"Low Dose Naltrexone for Chronic Pain in Osteoarthritis and Inflammatory Arthritis","status":"WITHDRAWN","sponsor":"Brigham and Women's Hospital","startDate":"2020-01","conditions":"Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Psoriatic","enrollment":""},{"nctId":"NCT00817089","phase":"PHASE4","title":"Understanding Treatment Response With Naltrexone Among White Alcoholics","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2007-12","conditions":"Alcoholism","enrollment":24},{"nctId":"NCT03678792","phase":"PHASE3","title":"Comparison of Three Opioid Detoxification Treatment Regimens","status":"WITHDRAWN","sponsor":"University of Alabama at Birmingham","startDate":"2019-11-15","conditions":"Opioid-Related Disorders, Opioid Withdrawal","enrollment":""},{"nctId":"NCT03854942","phase":"PHASE1","title":"Study of the Opioid Modulation of the Effect of Alcohol on the Dopaminergic Reward System","status":"TERMINATED","sponsor":"RWTH Aachen University","startDate":"2011-08-30","conditions":"Alcohol Addiction","enrollment":43},{"nctId":"NCT03132571","phase":"PHASE2","title":"Naltrexone-Bupropion Versus Placebo-Bupropion for Weight Loss in Schizophrenia","status":"TERMINATED","sponsor":"Yale University","startDate":"2017-06-01","conditions":"Schizophrenia, Diabetes Mellitus, Type 2, Obesity","enrollment":5},{"nctId":"NCT03766893","phase":"EARLY_PHASE1","title":"Medication Maintenance Therapy in Community Pharmacy Settings","status":"COMPLETED","sponsor":"Lifespan","startDate":"2018-09-01","conditions":"Opioid-use Disorder","enrollment":11},{"nctId":"NCT03975010","phase":"PHASE1","title":"Buprenorphine Transdermal Patches Pharmacokinetic Study","status":"UNKNOWN","sponsor":"Mundipharma (China) Pharmaceutical Co. Ltd","startDate":"2019-05-13","conditions":"Chronic Pain","enrollment":45},{"nctId":"NCT03879460","phase":"PHASE1","title":"The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations","status":"COMPLETED","sponsor":"Timothy Smith","startDate":"2019-03-18","conditions":"Opioid Intoxication","enrollment":15},{"nctId":"NCT01723384","phase":"PHASE2","title":"Intermittent Naltrexone Among Polysubstance Users","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2013-05","conditions":"Methamphetamine, Alcohol","enrollment":30},{"nctId":"NCT00218426","phase":"PHASE2, PHASE3","title":"Addiction Treatment in Russia: Oral vs. Naltrexone Implant","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2006-07","conditions":"Heroin Dependence, Opioid-Related Disorders","enrollment":306},{"nctId":"NCT02537574","phase":"PHASE3","title":"Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)","status":"COMPLETED","sponsor":"Alkermes, Inc.","startDate":"2015-08","conditions":"Opioid Use Disorder","enrollment":380},{"nctId":"NCT01856712","phase":"PHASE3","title":"Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence","status":"COMPLETED","sponsor":"University of Wisconsin, Madison","startDate":"2013-05","conditions":"Alcohol Dependence","enrollment":54},{"nctId":"NCT01101815","phase":"PHASE2","title":"Adherence to HIV Therapy in Heroin Addicts: Oral vs XR-NTX","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2010-06","conditions":"HIV, Substance Abuse, HIV Infections","enrollment":200}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":322,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Revia","Vivitrol","buprenorphine and oral naltrexone followed by Vivitrol","PBO","Vivitrol®"],"phase":"marketed","status":"active","brandName":"Oral Naltrexone","genericName":"Oral Naltrexone","companyName":"New York State Psychiatric Institute","companyId":"new-york-state-psychiatric-institute","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Oral naltrexone is an opioid receptor antagonist that blocks the effects of opioids and endogenous opioid peptides in the central and peripheral nervous system. Used for Opioid use disorder (maintenance treatment to prevent relapse), Alcohol use disorder, Chronic pain (off-label, particularly at low doses).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}