Clinical trials: Opioid Overdose
Opioid Overdose
Pharmacokinetic (PK) Evaluation of Nalmefene Formulations
This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.
- Trial name
- NCT07543276
- Testing
- Nalmefene + 0.94% MgCl2, Nalmefene Hydrochloride Injection
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Knoa Pharma LLC
Opioid Overdose
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into…
- Trial name
- NCT06719986
- Testing
- Nalmefene HCl injection, Naloxone HCl intranasal
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Opioid Overdose
Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics
Retrospective study to assess incidence and predictors of opioid abuse overdose and death associated with opioid overdose among patients prescribed opioid products in long-term use.
- Trial name
- NCT02662153
- Testing
- Observation only
- Where
- 4 sites in United States
- Volunteers
- 808,455 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02866266
- Testing
- Retrospective database review
- Volunteers
- 183,452 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opioid Overdose
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
- Trial name
- NCT05377255
- Testing
- 16 mg naloxone AP003, 8 mg naloxone NARCAN Nasal Spray
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Opioid Overdose
Developing and Testing the Opioid Rapid Response System
This Phase I SBIR will develop and demonstrate the usability/feasibility of the Opioid Rapid Response System (OSSR) in order to reduce deaths and strain on emergency response systems from opioid overdoses.
- Trial name
- NCT04589676
- Testing
- Naloxone training
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Real Prevention, LLC
Drug Overdose, Opioid-Related Disorders
Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose
RTM Vital Signs, LLC is developing a miniature wearable tracheal sound sensor that communicates with a cell phone containing a machine-learning diagnostic algorithm designed to detect and predict the onset of mild, moderate, and…
- Trial name
- NCT03845699
- Testing
- Diagnostic algorithms that detects/predicts hypoventilation
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- RTM Vital Signs, LLC
Opioid Overdose
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
This study is to compare the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given as a single dose intranasally (IN;into the nose), as a single dose in each nostril and…
- Trial name
- NCT05219669
- Testing
- Nalmefene Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Opiant Pharmaceuticals Inc
Opioid Overdose, Opioid Use Disorder
Safety, Tolerability, and Pharmacokinetics of CSX-1004
This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult…
- Trial name
- NCT06005402
- Testing
- CSX-1004
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cessation Therapeutics, Inc.
Opioid Overdose
Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers
The study consists of two Phases with the first phase (Pilot Phase) divided into two sub phases. In each study phase, subjects will be admitted to the clinical unit from 10 hours prior to the first drug administration on Day -1…
- Trial name
- NCT05363501
- Testing
- IM Naloxone Injection, Naloxone Nasal Spray, Naloxone Nasal Swab
- Where
- Canada
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pocket Naloxone Corp
Opioid-Related Disorders, Opiate Addiction
Study to Validate Coded Medical Terms Used to Identify Opioid-Related Overdose in Databases Used for PMR Study 1B
The purpose of this study is to determine reliability of codes and data from electronic medical records to predict and measure overdose and death in patients prescribed opioid analgesics.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02667197
- Testing
- Algorithm to determine overdose from opioid abuse
- Volunteers
- 2,701 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Opioid Use Disorder, Opioid Withdrawal
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
IBO-CARE is a single-site Phase 1/2a study evaluating the safety, tolerability, feasibility and preliminary outcomes of medically supervised ibogaine with 12 months of recovery support in adults with moderate-to-severe opioid use…
- Conditions
- Opioid Use Disorder, Opioid Withdrawal, Substance Use Disorders
- Trial name
- IBO-CARE (NCT07871877)
- Testing
- Ibogaine Hydrochloride, Extended-release naltrexone injection, 380 mg, My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Clive Michelsen
Opioid Overdose
Clinical Outcomes From Nalmefene
The purpose of this study is to assess the effectiveness of nalmefene relative to naloxone for the reversal of opioid intoxication in emergency department (ED) settings.
- Trial name
- COINED (NCT05808881)
- Testing
- Nalmefene Hydrochloride Injection, Naloxone Hydrochloride Injection
- Sponsor
- Purdue Pharma LP
Opioid Overdose
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder.
- Trial name
- NCT04713709
- Testing
- Nasus Pharma FMXIN001, Nasal Naloxone liquid spray
- Where
- Canada
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Nasus Pharma
Opioid Overdose
Naloxone Nasal Spray Pharmacokinetic Study
This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization…
- Trial name
- NCT01622504
- Testing
- MVP005, Naloxone hydrochloride solution for injection with mucosal atomization device
- Where
- Jordan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Mitovie Pharma Ltd