{"id":"naltrexon","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Nausea","drugRate":"10%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Nervousness","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Insomnia","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Anxiety","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Somnolence","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Abdominal cramps","drugRate":"","severity":"common","organSystem":""},{"effect":"Restlessness","drugRate":"","severity":"common","organSystem":""},{"effect":"Bone or joint pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Myalgia","drugRate":"","severity":"common","organSystem":""},{"effect":"Nasal symptoms","drugRate":"","severity":"common","organSystem":""},{"effect":"Tearfulness","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Acute exacerbation of asthma","Acute hepatic failure","Acute hepatitis","Acute nephropathy","Acute pancreatitis","Alcohol intoxication","Alcohol withdrawal delirium","Benign intracranial hypertension","Benign prostatic hyperplasia","Central nervous system depression","Chronic diarrhea","Chronic disease of respiratory system","Chronic obstructive lung disease","Cor pulmonale","Decreased respiratory function","Depressive disorder","Disease of liver","Disorder of biliary tract","Disorder of gallbladder","Drug-induced psychosis","Eosinophilic asthma","Gastrointestinal obstruction","Gastrointestinal perforation","Gastrointestinal ulcer","Hepatic failure","Hypercapnia","Hypothyroidism","Impaired renal function disorder","Increased Creatine Phosphokinase","Injury of head","Low blood pressure","Macrocolon","Opioid Use Within Last 4 Hours in Narcotic-Dependent Patient","Opioid dependence","Opioid withdrawal","Pain in Opioid Naive Patients","Paralytic ileus","Primary adrenocortical insufficiency","Primary malignant neoplasm of gastrointestinal tract","Seizure disorder","Severe diarrhea","Shock","Substance abuse","Suicidal thoughts","Urethral stricture"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Hepatocellular injury","drugRate":"","severity":"serious"},{"effect":"Precipitated opioid withdrawal","drugRate":"","severity":"serious"},{"effect":"Depression","drugRate":"","severity":"serious"},{"effect":"Suicidal ideation","drugRate":"","severity":"serious"},{"effect":"Suicidal attempts","drugRate":"","severity":"serious"}]},"trials":[],"_chembl":null,"aliases":[],"patents":[{"applNo":"N021897","source":"FDA Orange Book","status":"Active","expires":"Oct 15, 2029","territory":"US","drugProduct":false,"patentNumber":"7919499","drugSubstance":false}],"pricing":[],"_fixedAt":"2026-03-30T18:29:19.637550","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Naltrexon","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:18:54.431650+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T01:18:54.431545+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:18:59.590655+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Naltrexon","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:19:00.120015+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Opioid receptors; mu/kappa/delta antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:19:01.180187+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201149/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:19:00.837667+00:00"}},"offLabel":[],"timeline":[],"_dailymed":{"setId":"d8433c5e-deb3-4f20-aaf6-9fed6bc44974","title":"NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]"},"ecosystem":[],"mechanism":{"target":"Neuronal acetylcholine receptor subunit alpha-7, Cytochrome P450 2D6, Delta-type opioid receptor"},"_scrapedAt":"2026-03-28T05:16:49.167Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:19:02.522890+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Alcoholism","diseaseId":"alcoholism","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Chronic Pain with Opioid Tolerance","diseaseId":"chronic-pain-with-opioid-tolerance","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Chronic pain","diseaseId":"chronic-pain","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Obesity","diseaseId":"obesity","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Prevention of opioid abuse","diseaseId":"prevention-of-opioid-abuse","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Severe Pain with Opioid Tolerance","diseaseId":"severe-pain-with-opioid-tolerance","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Severe pain","diseaseId":"severe-pain","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Therapeutic opioid induced constipation","diseaseId":"therapeutic-opioid-induced-constipation","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"_fixedFields":["generics(1)","patents(1)"],"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04599478","phase":"PHASE2, PHASE3","title":"Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Yale University","startDate":"2021-06-29","conditions":"Loss-of-control Eating, Obesity/Overweight","enrollment":160},{"nctId":"NCT05458609","phase":"PHASE3","title":"Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep","status":"COMPLETED","sponsor":"Baylor College of Medicine","startDate":"2023-02-09","conditions":"Alcohol Use Disorder","enrollment":8},{"nctId":"NCT05925959","phase":"NA","title":"Preoperative Weight Loss for Open Abdominal Wall Reconstruction","status":"RECRUITING","sponsor":"Benjamin T. Miller","startDate":"2023-06-19","conditions":"Abdominal Wall Hernia","enrollment":258},{"nctId":"NCT07398404","phase":"PHASE1, PHASE2","title":"A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients","status":"NOT_YET_RECRUITING","sponsor":"Yale University","startDate":"2026-07-01","conditions":"Obesity, Smoking Cessation, Bariatric Surgery Patients","enrollment":64},{"nctId":"NCT05430152","phase":"PHASE2","title":"Low-dose Naltrexone for Post-COVID Fatigue Syndrome","status":"COMPLETED","sponsor":"Luis Nacul","startDate":"2024-01-15","conditions":"Post-Viral Fatigue Syndrome","enrollment":160},{"nctId":"NCT07224087","phase":"PHASE1","title":"Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients","status":"RECRUITING","sponsor":"Yale University","startDate":"2026-03-02","conditions":"Obesity, Smoking Cessation, Bariatric Surgery Patients","enrollment":20},{"nctId":"NCT07475546","phase":"PHASE3","title":"Combination Gerotherapeutic Interventions for Healthspan Improvement","status":"ACTIVE_NOT_RECRUITING","sponsor":"AgelessRx","startDate":"2025-07-23","conditions":"Healthspan Improvement, Aging, Longevity","enrollment":30},{"nctId":"NCT07213466","phase":"PHASE4","title":"Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2026-01-19","conditions":"Bipolar I Disorder, Bipolar II Disorder, Schizo Affective Disorder","enrollment":100},{"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":"NCT07433413","phase":"PHASE3","title":"Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use Disorder","status":"NOT_YET_RECRUITING","sponsor":"Shenzhen Sciencare Medical Industries Co., Ltd.","startDate":"2026-03-15","conditions":"Alcohol Use Disorder (AUD)","enrollment":240},{"nctId":"NCT05382091","phase":"PHASE2","title":"Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons","status":"NOT_YET_RECRUITING","sponsor":"Go Medical Industries Pty Ltd","startDate":"2026-07-15","conditions":"Opioid Use Disorder","enrollment":250},{"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":"NCT04245423","phase":"NA","title":"The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Pennsylvania","startDate":"2020-12-15","conditions":"Opioid-use Disorder, Mental Health Conditions","enrollment":567},{"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":"NCT07064564","phase":"PHASE1","title":"iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers","status":"NOT_YET_RECRUITING","sponsor":"Akyso Therapeutics, LLC","startDate":"2026-04-01","conditions":"Opioid Use Disorder","enrollment":33},{"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":"NCT02867124","phase":"PHASE3","title":"Long-acting Naltrexone for Pre-release Prisoners","status":"COMPLETED","sponsor":"Friends Research Institute, Inc.","startDate":"2017-01-01","conditions":"Opiate Addiction","enrollment":240},{"nctId":"NCT05338151","phase":"NA","title":"Promoting Alcohol Treatment Engagement Post-hospitalization","status":"RECRUITING","sponsor":"Yale University","startDate":"2022-09-13","conditions":"Alcohol Use Disorder","enrollment":450},{"nctId":"NCT04605081","phase":"PHASE2, PHASE3","title":"Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Yale University","startDate":"2022-01-10","conditions":"Loss-of-Control Eating, Obesity/Overweight","enrollment":100},{"nctId":"NCT06605703","phase":"PHASE4","title":"A Randomized Controlled Trial Comparing the Effectiveness of Different Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide (GLP1 Transition Trial)","status":"ACTIVE_NOT_RECRUITING","sponsor":"WW International Inc","startDate":"2024-09-18","conditions":"Obesity, Overweight","enrollment":226},{"nctId":"NCT04408313","phase":"PHASE2, PHASE3","title":"Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail","status":"ACTIVE_NOT_RECRUITING","sponsor":"Friends Research Institute, Inc.","startDate":"2020-10-28","conditions":"Opioid-use Disorder","enrollment":240},{"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":"NCT05028062","phase":"PHASE4","title":"Naltrexone in AUD Reward Drinkers","status":"RECRUITING","sponsor":"University of Pennsylvania","startDate":"2022-03-07","conditions":"Alcohol Use Disorder, Alcoholism","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":"NCT05503927","phase":"","title":"A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy","status":"ENROLLING_BY_INVITATION","sponsor":"Novo Nordisk A/S","startDate":"2023-01-02","conditions":"Pregnancy, Obesity, Overweight","enrollment":1139},{"nctId":"NCT07001371","phase":"NA","title":"Emotional Brain Training for Addiction Medicine Treatment - A Pilot Study","status":"NOT_YET_RECRUITING","sponsor":"Loma Linda University","startDate":"2026-03","conditions":"Cannabis Use Disorder, Stimulant Use Disorder, Opioid Use Disorder","enrollment":54},{"nctId":"NCT07333638","phase":"PHASE2","title":"Phase II Clinical Study on the Efficacy and Safety of Naltrexone Implant in Patients With Alcohol Use Disorder","status":"COMPLETED","sponsor":"Shenzhen Sciencare Medical Industries Co., Ltd.","startDate":"2023-04-03","conditions":"AUD","enrollment":210},{"nctId":"NCT03946111","phase":"PHASE2, PHASE3","title":"Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders","status":"COMPLETED","sponsor":"Yale University","startDate":"2019-08-07","conditions":"Binge-Eating Disorder, Obesity","enrollment":3},{"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":"NCT04464980","phase":"PHASE2","title":"Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)","status":"ACTIVE_NOT_RECRUITING","sponsor":"NYU Langone Health","startDate":"2021-06-08","conditions":"Opioid Use Disorder (OUD)","enrollment":1516},{"nctId":"NCT06854614","phase":"PHASE4","title":"Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)","status":"ACTIVE_NOT_RECRUITING","sponsor":"The Cleveland Clinic","startDate":"2025-03-01","conditions":"Obesity","enrollment":150},{"nctId":"NCT06845345","phase":"PHASE4","title":"Effect of Mediterranean Diet Combined With Intermittent Fasting on Liver Fibrosis Compared to Naltrexone/Bupropion in People With Cardiometabolic Risk Factors (MEDFAST-study)","status":"ENROLLING_BY_INVITATION","sponsor":"Carmen Dietvorst","startDate":"2025-04-14","conditions":"Diabetes Mellitus, Type 2, Liver Fibrosis, Liver Steatoses","enrollment":70},{"nctId":"NCT04345718","phase":"PHASE2, PHASE3","title":"EXHIT ENTRE Comparative Effectiveness Trial","status":"COMPLETED","sponsor":"Gavin Bart","startDate":"2021-08-09","conditions":"Substance Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe","enrollment":344},{"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":"NCT05685225","phase":"PHASE2","title":"Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial","status":"WITHDRAWN","sponsor":"Allodynic Therapeutics, Inc","startDate":"2025-01-31","conditions":"Migraine","enrollment":""},{"nctId":"NCT07262190","phase":"NA","title":"NavSTAR Implementation Effectiveness Trial Across a Health System","status":"RECRUITING","sponsor":"Friends Research Institute, Inc.","startDate":"2025-10-27","conditions":"Opioid Use Disorder","enrollment":720},{"nctId":"NCT06306157","phase":"PHASE4","title":"Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome","status":"ENROLLING_BY_INVITATION","sponsor":"Hospital for Special Surgery, New York","startDate":"2024-01-02","conditions":"Complex Regional Pain Syndrome, Chronic Pain, Causalgia","enrollment":40},{"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":"NCT06774248","phase":"NA","title":"Expanding the Youth Opioid Recovery Support (YORS) Intervention for MOUD Adherence to Adolescents With OUD","status":"RECRUITING","sponsor":"Potomac Health Foundations","startDate":"2025-02-01","conditions":"Opioid Use Disorder","enrollment":80},{"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":"NCT06303778","phase":"NA","title":"Combining a Smartphone App With Medications to Manage Heavy Drinking","status":"RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2024-11-01","conditions":"Alcohol Use Disorder (AUD)","enrollment":330},{"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":"NCT06877572","phase":"","title":"Weight Loss Management in Endometrial Cancer Survivors","status":"RECRUITING","sponsor":"University of Kansas Medical Center","startDate":"2025-03-25","conditions":"Endometrial Cancer Survivors, Weight Management, Early Stage Endometrial Cancer","enrollment":50},{"nctId":"NCT06366724","phase":"PHASE2","title":"LIFT: Life Improvement Trial","status":"RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2024-09-10","conditions":"ME/CFS, Long COVID, PASC","enrollment":160},{"nctId":"NCT05262270","phase":"PHASE2","title":"Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2023-04-18","conditions":"Cocaine Use Disorder","enrollment":427},{"nctId":"NCT06723561","phase":"PHASE2","title":"Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury","status":"RECRUITING","sponsor":"Medical College of Wisconsin","startDate":"2025-02-01","conditions":"Central Neuropathic Pain, Spinal Cord Injury","enrollment":10},{"nctId":"NCT04166071","phase":"EARLY_PHASE1","title":"Opioids and Social Support Enhanced Extinction Effects","status":"ENROLLING_BY_INVITATION","sponsor":"University of California, Los Angeles","startDate":"2021-12-13","conditions":"Fear","enrollment":60},{"nctId":"NCT07211724","phase":"NA","title":"Methamphetamine Use Disorder Support in Heart Failure Pilot Study","status":"NOT_YET_RECRUITING","sponsor":"University of Southern California","startDate":"2025-11-01","conditions":"Heart Failure, Methamphetamine Use Disorder","enrollment":50},{"nctId":"NCT04173416","phase":"NA","title":"The Youth Opioid Recovery Support (YORS) Intervention","status":"RECRUITING","sponsor":"Potomac Health Foundations","startDate":"2020-02-17","conditions":"Opioid-use Disorder, Medication Adherence","enrollment":150},{"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":"NCT05620940","phase":"PHASE1","title":"A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.","status":"RECRUITING","sponsor":"Inventage Lab., Inc.","startDate":"2024-09-11","conditions":"Opioid Dependence, Alcohol Dependence, Multiple Sclerosis","enrollment":40},{"nctId":"NCT05756764","phase":"","title":"Anti-obesity Pharmacotherapy and Inflammation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Louisiana State University Health Sciences Center in New Orleans","startDate":"2023-06-01","conditions":"Obesity","enrollment":30},{"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":"NCT06620562","phase":"PHASE4","title":"Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet","status":"RECRUITING","sponsor":"Laval University","startDate":"2025-06-04","conditions":"Obesity; Drug, Obesity, Morbid","enrollment":108},{"nctId":"NCT04454411","phase":"PHASE2","title":"Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder","status":"TERMINATED","sponsor":"University of Pennsylvania","startDate":"2022-08-01","conditions":"Opioid Dependence","enrollment":3},{"nctId":"NCT07092618","phase":"PHASE2, PHASE3","title":"Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation","status":"RECRUITING","sponsor":"AgelessRx","startDate":"2024-12-17","conditions":"Longevity, GLP-1, Geroscience","enrollment":150},{"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":"NCT05189223","phase":"NA","title":"A Brief Values Intervention to Support Veterans in Early Buprenorphine Treatment","status":"RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2023-09-01","conditions":"Dependence, Opioid","enrollment":50},{"nctId":"NCT05053503","phase":"NA","title":"Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder","status":"COMPLETED","sponsor":"Spark Biomedical, Inc.","startDate":"2022-05-27","conditions":"Opioid-use Disorder, Opioid Withdrawal","enrollment":108},{"nctId":"NCT06216132","phase":"PHASE1","title":"Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults","status":"COMPLETED","sponsor":"Akyso Therapeutics, LLC","startDate":"2024-06-24","conditions":"Opioid Use Disorder","enrollment":16},{"nctId":"NCT06021431","phase":"NA","title":"Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT","status":"ACTIVE_NOT_RECRUITING","sponsor":"BehaVR LLC","startDate":"2023-09-07","conditions":"Opioid Use Disorder","enrollment":128},{"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":"NCT05157698","phase":"PHASE2, PHASE3","title":"Pharmacological and Behavioral Treatment After Bariatric Surgery","status":"RECRUITING","sponsor":"Yale University","startDate":"2022-01-13","conditions":"Obesity","enrollment":160},{"nctId":"NCT00006203","phase":"PHASE4","title":"Naltrexone, Craving, and Drinking","status":"COMPLETED","sponsor":"Brown University","startDate":"","conditions":"Alcoholism","enrollment":180},{"nctId":"NCT07014644","phase":"PHASE2","title":"A Randomized, Double-Blind, Single-Center Clinical Study on the Efficacy of Naltrexone Implant in Antagonizing Opioid Agonist Hydromorphone","status":"COMPLETED","sponsor":"Shenzhen Sciencare Medical Industries Co., Ltd.","startDate":"2018-08-07","conditions":"Opioid Dependence","enrollment":31},{"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":"NCT02502162","phase":"NA","title":"Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome","status":"RECRUITING","sponsor":"Stanford University","startDate":"2015-06","conditions":"Complex Regional Pain Syndrome","enrollment":120},{"nctId":"NCT04363320","phase":"NA","title":"Fostering MAT Use in Justice Populations","status":"COMPLETED","sponsor":"University of Wisconsin, Madison","startDate":"2020-07-30","conditions":"Opioid-use Disorder, Recidivism","enrollment":256},{"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":"NCT03407638","phase":"NA","title":"PRimary Care Opioid Use Disorders Treatment (PROUD) Trial","status":"COMPLETED","sponsor":"Kaiser Permanente","startDate":"2018-02-28","conditions":"Opioid-use Disorder","enrollment":973759},{"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":"NCT05011266","phase":"PHASE2, PHASE3","title":"Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder","status":"RECRUITING","sponsor":"New York State Psychiatric Institute","startDate":"2023-04-18","conditions":"Opioid-use Disorder","enrollment":180},{"nctId":"NCT05919797","phase":"PHASE4","title":"Weight Loss Study: Genetics and Response to Naltrexone/Bupropion","status":"RECRUITING","sponsor":"Columbia University","startDate":"2023-06-08","conditions":"Obesity","enrollment":120},{"nctId":"NCT06633900","phase":"PHASE2, PHASE3","title":"Naltrexone for Overdose Prevention","status":"RECRUITING","sponsor":"University of California, San Francisco","startDate":"2025-04-10","conditions":"Overdose Accidental","enrollment":100},{"nctId":"NCT02330419","phase":"PHASE2","title":"Better Than Study: Targeting Heavy Alcohol Use With Naltrexone Among Men Who Have Sex With Men (MSM)","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2015-04","conditions":"Binge Drinking, HIV","enrollment":120},{"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":"NCT02461927","phase":"PHASE1, PHASE2","title":"Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder","status":"COMPLETED","sponsor":"VA Office of Research and Development","startDate":"2015-01-01","conditions":"Major Depressive Disorder, Alcohol Use Disorder","enrollment":65},{"nctId":"NCT06881485","phase":"NA","title":"Naltrexone/Bupropion With or Without Very Low Calorie Ketogenic Diet for Weight Regain After Bariatric Surgery","status":"RECRUITING","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2025-01-20","conditions":"Weight Regain Post Bariatric Surgery, Obesity (Disorder)","enrollment":62},{"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":"NCT04499950","phase":"PHASE2","title":"Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study","status":"COMPLETED","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2021-02-08","conditions":"Breast Cancer, Overweight or Obesity","enrollment":53},{"nctId":"NCT04581603","phase":"PHASE4","title":"CBT-I Augmentation of Medication for Drinking in AUD","status":"TERMINATED","sponsor":"VA Office of Research and Development","startDate":"2022-06-15","conditions":"Alcohol Use Disorder With Insomnia","enrollment":82},{"nctId":"NCT05812183","phase":"PHASE4","title":"Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity","status":"WITHDRAWN","sponsor":"University of California, Los Angeles","startDate":"2023-07-09","conditions":"Dyspnea, Quality of Life","enrollment":""},{"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":"NCT04309565","phase":"NA","title":"Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support","status":"ACTIVE_NOT_RECRUITING","sponsor":"Yale University","startDate":"2021-04-21","conditions":"Opioid Addiction","enrollment":400},{"nctId":"NCT04139668","phase":"PHASE2","title":"Vivitrol Treatment for Cannabis Use Disorder","status":"TERMINATED","sponsor":"Centre for Addiction and Mental Health","startDate":"2021-06-09","conditions":"Cannabis Use Disorder","enrollment":1},{"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":"NCT05042388","phase":"NA","title":"Mindfulness-Based Relapse Prevention to Improve Medication Assisted Treatment Adherence and Drug-use Outcomes for Opioid Use Disorder","status":"COMPLETED","sponsor":"West Chester University of Pennsylvania","startDate":"2021-08-01","conditions":"Opioid-use Disorder","enrollment":105},{"nctId":"NCT03810495","phase":"PHASE1","title":"The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers","status":"COMPLETED","sponsor":"Go Medical Industries Pty Ltd","startDate":"2019-04-11","conditions":"Opioid Use Disorder","enrollment":20}],"_emaApprovals":[],"_faersSignals":[{"count":17,"reaction":"BETA HAEMOLYTIC STREPTOCOCCAL INFECTION"},{"count":17,"reaction":"LOSS OF CONSCIOUSNESS"},{"count":17,"reaction":"NECROSIS ISCHAEMIC"},{"count":17,"reaction":"PNEUMONIA STREPTOCOCCAL"},{"count":17,"reaction":"SEPTIC SHOCK"},{"count":9,"reaction":"DRUG INTERACTION"},{"count":5,"reaction":"CONSTIPATION"},{"count":5,"reaction":"FATIGUE"},{"count":5,"reaction":"SUICIDE ATTEMPT"},{"count":4,"reaction":"DEPRESSED MOOD"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"_patentsChecked":true,"crossReferences":{"chemblId":"CHEMBL1201149"},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":18,"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturers":1,"_genericFilersChecked":true,"genericManufacturerList":["Teva Pharms Usa Inc"],"phase":"marketed","status":"active","brandName":"Naltrexon","genericName":"Naltrexon","companyName":"Institute of Liver and Biliary Sciences, India","companyId":"institute-of-liver-and-biliary-sciences-india","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:19:02.522890+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}