94 completed, 12 terminated, 9 withdrawn, 7 recruiting. 32 Phase 1, 30 Phase 2, 29 Phase 4, 26 Not applicable, 17 Phase 3.
Follow Naloxone: new trials by email Literature Review of Naloxone trials Research Report on Naloxone
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 |
|---|---|---|---|---|---|---|
| Naloxone for Opioid Associated Out of Hospital Cardiac Arrest Naloxone 2 MG, Saline 2ml - Heart Arrest, Out-Of-Hospital, Opioid Overdose | Phase 2 | Not yet recruiting | University of California, San Francisco | 98 | 2027-03-01 | 2026-09-11 |
| Naloxone for In-Hospital Cardiac Arrest naloxone, Placebo - Heart Arrest | Phase 2 / Phase 3 | Not yet recruiting | Region Skane | 850 | 2027-01-01 | 2026-09-08 |
| Sedation and Guided Education for Depression Study Response-focused education, Diagnosis-focused education, IV naloxone - Major Depressive Disorder (MDD) | Not applicable | Not yet recruiting | Stanford University | 40 | 2026-09-01 | 2026-10-16 |
| The Role of the Opioid System in Placebo Effects on Pain and Social Rejection Placebo Cream with Naloxone, Control Cream with Naloxone, Placebo Cream with Saline - Pain, Rejection | Early Phase 1 | Not yet recruiting | Trustees of Dartmouth College | 60 | 2026-09-01 | 2025-12-09 |
| A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade Naloxone Hydrochloride, Fentanyl, Sterile Saline - Fentanyl Overdose, Fentanyl Poisoning | Phase 2 | Recruiting | Clear Scientific, Inc. | 16 | 2026-05-28 | 2026-08-24 |
| Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial Naloxone Hydrochloride 0.4 MG/ML, Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg), Buprenorphine extended-release injection (300 mg/1.5 mL) - Opioid Use Disorder | Phase 4 | Recruiting | Pouya Azar | 12 | 2026-04-29 | 2026-05-01 |
| A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use Buprenorphine + naloxone (Suboxone), Buprenorphine Injection - Opioid Use Disorder | Early Phase 1 | Recruiting | Rachel R. Luba | 60 | 2026-02-25 | 2026-06-02 |
| A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Brief youth overdose prevention education, Information about Naloxone, Usual standard of care - Overdose | Not applicable | Active not recruiting | Boston Medical Center | 22 | 2025-08-25 | 2026-08-07 |
| Feasibility of Pediatric Emergency Department-Initiated Treatment for Adolescents With Opioid Use Disorder ED-Initiated treatment with buprenorphine / naloxone - Opioid-use Disorder | Phase 2 | Withdrawn | University of California, Davis | 2025-07-30 | 2024-11-12 | |
| Opioid Antagonism in Hypogonadotropic Hypogonadism Naloxone - Hypogonadotropic Hypogonadism, Low Testosterone | Phase 1 | Completed | Stephanie B. Seminara, MD | 23 | 2025-06-18 | 2026-06-03 |
| Milk Beta Caseins on Digestive Discomfort, Gastric Emptying A1/A2 milk with oral naloxone, A1PF milk with oral naloxone - Lactose Intolerants, Lactose Malabsorption | Not applicable | Completed | Purdue University | 10 | 2025-01-30 | 2026-10-20 |
| Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone Buprenorphine/Naloxone + BEM/RZR, Methadone +BEM/RZR - Healthy Volunteer Study | Phase 1 | Recruiting | Atea Pharmaceuticals, Inc. | 32 | 2025-01-07 | 2026-07-16 |
| Nalmefene vs Naloxone for the Treatment of Recurrent Respiratory Depression After Opioid Overdose Nalmefene Injection, Naloxone Injection - Opioid Overdose, Opiate Overdose | Phase 3 | Withdrawn | University of New Mexico | 2024-08-26 | 2025-02-10 | |
| Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone) Naloxone, Usual intervention - Overdose, Implementation as Usual | Not applicable | Active not recruiting | RTI International | 31 | 2023-07-01 | 2026-10-20 |
| Clinical Outcomes From Nalmefene Nalmefene Hydrochloride Injection, Naloxone Hydrochloride Injection - Opioid Overdose | Phase 4 | Withdrawn | Purdue Pharma LP | 2023-06-01 | 2023-07-12 | |
| RM1 Project 1 - tAN Naloxone Naloxone, Saline - Analgesia | Early Phase 1 | Recruiting | Medical University of South Carolina | 136 | 2023-03-22 | 2025-12-18 |
| Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg Nalmefene HCl injection, Naloxone HCl intranasal - Opioid Overdose | Phase 1 | Completed | Purdue Pharma LP | 24 | 2022-10-03 | 2025-07-03 |
| Multi-System Analysis of Opioid Receptor Binding Carfentanil, C-11, Naloxone, Loperamide Hydrochloride - Healthy, Opioid Use Disorder | Phase 1 | Active not recruiting | University of Pennsylvania | 25 | 2022-09-20 | 2026-03-30 |
| Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists Narcan 40 MG/ML Nasal Spray, Naloxone Hydrochloride, Nalmefene HCl injection - Opioid Induced Respiratory Depression, Chronic Opioid Use | Phase 1 | Terminated | Leiden University Medical Center | 58 | 2022-06-24 | 2026-07-29 |
| Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank Naloxone - Reproductive Disorders | Phase 1 | Completed | Stephanie B. Seminara, MD | 47 | 2022-06-03 | 2026-02-18 |
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Indivior Inc. (5) · Mundipharma Korea Ltd (5) · University of California, San Francisco (5) · National Institute on Drug Abuse (NIDA) (4) · Mundipharma Research GmbH & Co KG (3) · University of Maryland, Baltimore (3) · Albert Einstein College of Medicine (2) · Dartmouth-Hitchcock Medical Center (2) · Finnish Institute for Health and Welfare (2) · King's College London (2) · Mundipharma CVA (2) · New York State Psychiatric Institute (2) · Norwegian University of Science and Technology (2) · Purdue Pharma LP (2) · Stanford University (2)
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