249 completed, 25 terminated, 18 unknown, 18 withdrawn. 139 Phase 2, 75 Phase 4, 61 Phase 1, 55 Phase 3, 27 Not applicable.
Follow Naltrexone: new trials by email Literature Review of Naltrexone trials Research Report on Naltrexone
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons naltrexone implant - Opioid Use Disorder | Phase 2 | Not yet recruiting | Go Medical Industries Pty Ltd | 250 | 2027-01-01 | 2026-09-28 |
| A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia Low Dose Naltrexone - Vulvodynia | Phase 2 | Not yet recruiting | University of Florida | 20 | 2027-01-01 | 2026-10-09 |
| Combination Therapy for Alcohol Use Disorder Placebo, Glucagon-Like Peptide-1 Agonist (GLP-1), Naltrexone (oral tablets) - Alcohol Use Disorder | Phase 2 | Not yet recruiting | Johns Hopkins University | 45 | 2026-11-01 | 2026-10-01 |
| Low-Dose Naltrexone For ME/CFS: Dose-Finding Low-Dose Naltrexone, 1.5mg, Low-Dose Naltrexone, 3.0mg, Low-Dose Naltrexone, 4.5mg - Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | Phase 2 | Not yet recruiting | University of Alabama at Birmingham | 75 | 2026-11-01 | 2026-10-08 |
| Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients Naltrexone Hydrochloride, Bupropion HCl Extended Release, Cognitive-Behavioral Therapy - Obesity, Smoking Cessation | Phase 1 | Not yet recruiting | Medical University of South Carolina | 20 | 2026-10-01 | 2026-09-09 |
| A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients Naltrexone hydrochloride, Bupropion Hydrochloride Extended-release, Cognitive-Behavioral Therapy - Obesity, Smoking Cessation | Phase 1 / Phase 2 | Not yet recruiting | Medical University of South Carolina | 64 | 2026-09-01 | 2026-07-08 |
| Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT) Naltrexone - Metastatic Prostate Cancer | Phase 2 | Recruiting | University of Arkansas | 60 | 2026-08-25 | 2026-09-08 |
| iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers Naltrexone implant, 14.4 grams, Naltrexone implant, 9.6 grams, Extended-release naltrexone injection, 380 mg - Opioid Use Disorder | Phase 1 | Active not recruiting | Akyso Therapeutics, LLC | 33 | 2026-07-25 | 2026-09-30 |
| Predicting Response to Naltrexone With Eye Tracking in Gaming Disorder Naltrexone group A, Naltrexone, Psychoeducational - Gaming Disorder | Phase 2 | Recruiting | University of Sao Paulo | 40 | 2026-07-01 | 2026-07-27 |
| Low Dose Naltrexone Use in Patients With POTS Low Dose Naltrexone, Microcrystalline cellulose - Postural Orthostatic Tachycardia Syndrome | Phase 4 | Not yet recruiting | University of Calgary | 80 | 2026-07-01 | 2026-05-01 |
| Naltrexone for Nonsuicidal Self-Injury Naltrexone 50mg (Whanin Naltrexone Tab. 50mg), Placebo - Nonsuicidal Self-Injury, Self-Injurious Behavior | Not applicable | Not yet recruiting | Seoul National University Hospital | 150 | 2026-06-01 | 2026-06-11 |
| Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injury Naltrexone, Placebo - Nonsuicidal Self-Injury | Phase 2 | Not yet recruiting | Seoul National University Hospital | 150 | 2026-06-01 | 2026-05-22 |
| Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol BICX104 naltrexone implantable pellet, Bupropion 150 mg XL, Naltrexone (depot) - Healthy Adult Male and Female Volunteers | Phase 1 | Recruiting | BioCorRx Pharmaceuticals Inc | 30 | 2026-03-16 | 2026-05-13 |
| Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use Disorder Naltrexone, placebo - Alcohol Use Disorder (AUD) | Phase 3 | Not yet recruiting | Shenzhen Sciencare Medical Industries Co., Ltd. | 240 | 2026-03-15 | 2026-02-25 |
| Targeted Naltrexone to Support Individuals Participating in Dry January Naltrexone (oral tablets) - Alcohol Misuse | Phase 2 | Completed | Brigham and Women's Hospital | 19 | 2025-11-03 | 2026-04-29 |
| Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) Low-Frequency Electromagnetic Resonance Therapy (LF-EMR), Sham Resonance Device (Inactive Control), Low-Dose Naltrexone (LDN) - Systemic Lupus Erythematosus, Rheumatoid Arthritis | Phase 1 / Phase 2 | Enrolling by invitation | Truway Health, Inc. | 120 | 2025-10-23 | 2026-05-22 |
| Combination Gerotherapeutic Interventions for Healthspan Improvement Rapamycin, Naltrexone, Metformin - Healthspan Improvement, Aging | Phase 3 | Active not recruiting | AgelessRx | 30 | 2025-07-23 | 2026-03-16 |
| A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence Cannabidiol capsules, Naltrexone (drug), Placebo - Alcohol Addiction, Alcoholism | Phase 2 | Recruiting | Central Institute of Mental Health, Mannheim | 150 | 2025-07-22 | 2026-02-03 |
| Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet Naltrexone/Bupropion, Placebo - Obesity; Drug, Obesity, Morbid | Phase 4 | Recruiting | Laval University | 108 | 2025-06-04 | 2025-08-08 |
| Effect of an Early Time Restricted Eating Mediterranean Diet Compared to Naltrexone/Bupropion on Liver Fibrosis in People With Cardiometabolic Risk Factors in a Hospital Outpatient Clinic (MEDFAST-study) early time restricted Mediterranean diet, Mysimba - Diabetes Mellitus, Type 2, Liver Fibrosis | Phase 4 | Enrolling by invitation | Carmen Dietvorst | 70 | 2025-04-14 | 2026-04-21 |
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Alcoholism (98) · Opioid-Related Disorders (43) · Obesity (20) · Substance-Related Disorders (15) · Behavior, Addictive (13) · Alcohol Drinking (11) · Cocaine-Related Disorders (11) · Depression (11) · Chronic Pain (9) · Pain (9) · Smoking (9) · Alcohol-Related Disorders (8) · HIV Infections (8) · Heroin Dependence (8) · Tobacco Use Disorder (8)
Yale University (26) · University of Pennsylvania (14) · New York State Psychiatric Institute (11) · Alkermes, Inc. (10) · University of Minnesota (9) · Medical University of South Carolina (8) · National Institute on Alcohol Abuse and Alcoholism (NIAAA) (8) · National Institute on Drug Abuse (NIDA) (8) · Pfizer (8) · University of California, Los Angeles (6) · AgelessRx (5) · Allodynic Therapeutics, Inc (5) · Alza Corporation, DE, USA (5) · Central Institute of Mental Health, Mannheim (5) · Stanford University (5)
United States (253) · Canada (10) · Russia (9) · Germany (8) · China (5) · Israel (4) · Brazil (3) · Denmark (3) · South Korea (3) · United Kingdom (3) · Australia (2) · Finland (2) · India (2) · Netherlands (2) · New Zealand (2)
Bernard L. Silverman, MD (5) · Adam Bisaga, MD (4) · Gihyun Yoon, MD (3) · Jarred Younger, PhD (3) · Jon E Grant, M.D. (3) · Lara Ray, PhD (3) · Raymond F Anton, MD (3) · Sajad Zalzala, MD (3) · Adam Bisaga, M.D. (2) · Annette C Toledano, M.D. (2) · Annette Toledano, M.D. (2) · Caitlin E Smith, PhD (2) · Cenk Tek, MD (2)
PMID 40342086, PMID 36130734, PMID 11112243, PMID 15811981, PMID 16135345, PMID 17175134, PMID 18662331, PMID 19453963, PMID 20548058, PMID 22520687, PMID 23177384, PMID 23188075, PMID 23359310, PMID 25744676, PMID 26603732, PMID 28322750, PMID 29310498, PMID 36375174, PMID 10553740, PMID 11707638, PMID 1334156, PMID 1345133, PMID 1444726, PMID 15956269, PMID 16012278, PMID 16624967, PMID 16670409, PMID 16960700, PMID 17045423, PMID 17222320, PMID 17270055, PMID 17270058, PMID 17374042, PMID 17587504, PMID 17588491, PMID 17664051, PMID 17873686, PMID 18079068, PMID 18241321, PMID 18250251, PMID 18348601, PMID 18472999, PMID 18509902, PMID 18586174, PMID 18775624, PMID 18796184, PMID 18838638, PMID 19053979, PMID 19217077, PMID 19283561
P50AA015632 (4), R01DA010746 (3), K20DA000191 (2), P50DA009262 (2), P50DA012756 (2), P60DA005186 (2), R01AA009568 (2), R01DA014718 (2), R01DK126637 (2), U10DA013045 (2), UG3DA047720 (2), 1DP5OD019809 (1), 1UG3NS141843-01A1 (1), 2015 (1), 2019 (1)