16 completed, 2 unknown. 18 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 18 | Completed 16, Unknown 2 |
| Phase 2 | 2 | Completed 2 |
Follow Drug Misuse: new trials by email Literature Review of Drug Misuse trials Research Report on Drug Misuse
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 |
|---|---|---|---|---|---|---|
| Pharmacokinetic (PK) Evaluation of Nalmefene Formulations Nalmefene + 0.94% MgCl2, Nalmefene Hydrochloride Injection - Opioid Overdose | Phase 1 | Completed | Knoa Pharma LLC | 13 | 2026-02-06 | 2026-06-05 |
| Safety, Tolerability, and Pharmacokinetics of CSX-1004 CSX-1004, Placebo - Opioid Overdose, Opioid Use Disorder | Phase 1 | Completed | Cessation Therapeutics, Inc. | 32 | 2023-08-01 | 2024-08-21 |
| 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 |
| Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults 16 mg naloxone AP003, 8 mg naloxone NARCAN Nasal Spray - Opioid Overdose | Phase 1 | Completed | Emergent BioSolutions | 24 | 2022-03-28 | 2026-08-19 |
| Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens Nalmefene Hydrochloride - Opioid Overdose | Phase 1 | Completed | Opiant Pharmaceuticals Inc | 24 | 2021-09-01 | 2024-08-05 |
| A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder Nasus Pharma FMXIN001, Nasal Naloxone liquid spray - Opioid Overdose | Phase 1 | Completed | Nasus Pharma | 46 | 2021-01-31 | 2022-05-02 |
| Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers IM Naloxone Injection, Naloxone Nasal Spray, Naloxone Nasal Swab - Opioid Overdose | Phase 1 | Completed | Pocket Naloxone Corp | 76 | 2021-01-21 | 2022-05-06 |
| Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression Continuous conversational interaction, Remifentanil infusion - Opioid; Intoxication, Perception Disturbance (Acute), Acute Pain | Phase 1 | Completed | University of California, San Francisco | 20 | 2019-04-30 | 2020-03-10 |
| Buccal Versus Injectable Naloxone: a Phase I Healthy Volunteer Study Naloxone - Drug Overdose, Opioid-Related Disorders | Phase 1 | Unknown | King's College London | 4 | 2016-06-01 | 2016-05-17 |
| Bioavailability of Nasal Naloxone and Injected Naloxone Compared Intranasal (IN) naloxone 1x, Intranasal (IN) naloxone 2, Intravenous (IV) naloxone - Drug Overdose | Phase 1 | Completed | Norwegian University of Science and Technology | 22 | 2016-03-01 | 2017-02-03 |
| Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use Intranasal naloxone, Intramuscular naloxone, Remifentanil - Drug Overdose | Phase 1 / Phase 2 | Completed | Norwegian University of Science and Technology | 12 | 2014-12-01 | 2018-10-17 |
| Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers Naloxone - Drug Overdose, Opioid-Related Disorders | Phase 1 | Completed | National Institute on Drug Abuse (NIDA) | 30 | 2014-10-01 | 2017-01-12 |
| A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users EB-1020 400 mg, EB-1020 800 mg, lisdexamfetamine 150 mg - Healthy Volunteers, Drug Users | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 80 | 2014-05-01 | 2026-04-13 |
| Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use nasal naloxone - Drug Overdose | Phase 1 | Completed | Norwegian University of Science and Technology | 12 | 2014-03-01 | 2017-02-03 |
| A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers Placebo, intact ALO-02 60 mg/7.2 mg, crushed ALO-02 60 mg/7.2 mg - Healthy | Phase 1 | Completed | Pfizer | 81 | 2013-02-01 | 2018-10-19 |
| A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted ALO-02 weight-matched placebo, crushed ALO-02 30 mg/3.6 mg, oxycodone weight-matched placebo - Healthy | Phase 1 | Completed | Pfizer | 45 | 2013-02-01 | 2017-07-17 |
| Naloxone Nasal Spray Pharmacokinetic Study MVP005, Naloxone hydrochloride solution for injection with mucosal atomization device - Opioid Overdose | Phase 1 | Unknown | Mitovie Pharma Ltd | 6 | 2012-06-01 | 2012-06-20 |
| Development of a Family Intervention to Address Drug Use and HIV in Vietnam Family Intervention to Address Drug Use and HIV in Vietnam - Quality of Life | Phase 1 / Phase 2 | Completed | University of California, Los Angeles | 230 | 2010-07-01 | 2016-02-18 |
Opiate Overdose (9) · Drug Overdose (6) · Opioid-Related Disorders (5) · Chronic Pain (2) · Acute Pain (1) · Attention Deficit Disorder with Hyperactivity (1) · Respiratory Insufficiency (1)
Chemically-Induced Disorders (18) · Mental Disorders (18) · Substance-Related Disorders (18) · Prescription Drug Misuse (14) · Narcotic-Related Disorders (13) · Drug Overdose (8) · Opioid-Related Disorders (8) · Neurologic Manifestations (3) · Pain (3) · Pathological Conditions, Signs and Symptoms (3) · Signs and Symptoms (3) · Attention Deficit and Disruptive Behavior Disorders (1) · Neurodevelopmental Disorders (1) · Respiration Disorders (1)
Naloxone (5) · nalmefene (3) · 1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane (1) · Dextroamphetamine (1) · Injections (1) · Injections, Intramuscular (1) · Lisdexamfetamine Dimesylate (1) · Magnesium Chloride (1) · Remifentanil (1) · Seroconversion (1)
Norwegian University of Science and Technology (3) · Pfizer (2) · Cessation Therapeutics, Inc. (1) · Emergent BioSolutions (1) · King's College London (1) · Knoa Pharma LLC (1) · Mitovie Pharma Ltd (1) · Nasus Pharma (1) · National Institute on Drug Abuse (NIDA) (1) · Opiant Pharmaceuticals Inc (1) · Otsuka Pharmaceutical Development & Commercialization, Inc. (1) · Pocket Naloxone Corp (1) · Purdue Pharma LP (1) · University of California, Los Angeles (1) · University of California, San Francisco (1)
United States (8) · Canada (4) · Norway (3) · Jordan (1) · Vietnam (1)
Toril A Nagelhus Hernes, phd prof (3) · Abdullah Hiyari, MD (1) · Ingela Danielsson, MD (1) · Janice Faulknor, MD, CCFP (1) · John Strang, MBBS, MD (1) · Li Li, Ph.D (1) · Nino Joy, MD (1) · Rachel Eshima McKay, M.D. (1) · Sonnie Kim (1) · Steven Hull, MD (1)
PMID 26011742, PMID 28144724, PMID 29568976, PMID 33651243, PMID 35386013, PMID 37496452, PMID 42332351
2014 (1), 2015 (1)