Clinical trials: Naloxone
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 Dependence
XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs.
- Trial name
- NCT03604159
- Testing
- Buprenorphine Extended Release, Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Healthy Volunteer Study
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
- Trial name
- NCT07314346
- Testing
- Buprenorphine/Naloxone + BEM/RZR, Methadone +BEM/RZR
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Healthy
Study to Assess the PK Profile of NanoBUP Capsules Relative to Suboxone
Phase 1 study to determine the pharmacokinetic profile of NanoBUP Capsules to Suboxone.
- Trial name
- NCT01260675
- Testing
- Buprenorphine HCl/Naloxone HCl
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- NanoSHIFT LLC
Intestinal Obstruction
Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.
The purpose of this study is to describe the effects of repeated-dose methylnaltrexone in preventing loperamide-induced delay of whole-gut, oro-cecal and colon transit time and to measure pharmacokinetics of methylnaltrexone and…
- Trial name
- NCT01596764
- Testing
- Loperamide, Colon Transit, Sulfasalazine
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University Medicine Greifswald
Drug Overdose
Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use
Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, higher than road traffic accidents.
- Trial name
- OPI-14-001 (NCT02307721)
- Testing
- Intranasal naloxone, Intramuscular naloxone, Remifentanil
- Where
- Norway
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Norwegian University of Science and Technology
Healthy
Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity
In previous clinical studies of post-surgical pain the investigators found that nalbuphine (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (Narcan), a drug that is used to…
- Trial name
- NCT00947284
- Testing
- nalbuphine plus naloxone, nalbuphine plus saline, naloxone plus saline
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Suicide, Overdose Accidental
Pilot of Training on 988 and Narcan
This pilot study evaluates the acceptability, appropriateness, and feasibility of a new crisis response training called Crisis Ready.
- Conditions
- Suicide, Overdose Accidental, Overdose Antidote, Crisis Response Plan
- Trial name
- NCT07072819
- Testing
- Crisis Ready Training
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- RAND
Opioid Overdose, Drug Overdose
The Rhode Island Prescription and Illicit Drug Study
This study will test the efficacy of a novel drug-checking intervention to prevent fatal and non-fatal overdose among people who use drugs (PWUD), who are 18-65 years old at the time of enrollment.
- Trial name
- RAPIDS (NCT04372238)
- Testing
- RAPIDS Intervention, Standard OEND
- Where
- United States
- Volunteers
- 509 people, healthy volunteers welcome
- Sponsor
- Brown University
Overdose Antidote
Naloxone Auto-injection in Healthy Volunteers
This study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use.
- Trial name
- NCT05099614
- Testing
- Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Washington
Hypogonadotropic Hypogonadism
Neuropeptides in Human Reproduction
The investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system.
- Trial name
- NCT01952782
- Testing
- Kisspeptin 112-121, Naloxone, GnRH
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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
Heroin Dependence
Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone
The study is designed to compare the abuse liabilities of intranasal buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine.
- Trial name
- NCT01760473
- Testing
- Intranasal challenge drug
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Substance Abuse, Decision Making, Shared
Data2Action Oregon Project: Supporting Data-driven Decision-Making for Substance Use Services, Policy, and Overdose Prevention
Oregon's decision makers (e.g., community service providers, public health, justice, advocacy groups, payers) are calling for comprehensive, current, and trusted data to inform how they allocate resources to improve substance use…
- Conditions
- Substance Abuse, Decision Making, Shared, Implementation Science, Decision Making
- Trial name
- D2A Oregon (NCT06852170)
- Testing
- Co-Design Sessions (CDS), Data products
- Where
- United States
- Volunteers
- 341 people, healthy volunteers welcome
- Sponsor
- Chestnut Health Systems
Healthy Volunteer
A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers
The main objective of this study was to compare the bioavailability of two test formulations of Naloxone Nasal Spray with the reference formulations of Naloxone HCl IV and IM injection under fasted conditions.
- Trial name
- NCT03827642
- Testing
- Treatment A: Naloxone Nasal Spray, Treatment B: Naloxone Nasal Spray, Treatment C: Naloxone HCl Intravenous (IV) Injection
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
Healthy Volunteers
Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) Autoinjector
To compare the plasma concentration (bioavailability) and safety of a single naloxone 5 mg autoinjector intramuscular (IM) injection to a single 2 mg IM injection (an approved safe dose) and to a single 2 mg bolus intravenous…
- Trial name
- NCT05264493
- Testing
- NaxRedy ™, Naloxone Hydrochloride Injection, USP
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pain
Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers
The aim of this study is to check if Naloxone induce an inhibiting effect on the analgesic effect of paracetamol in healthy volunteer, using evoked potentials.
- Trial name
- NCT00750048
- Testing
- Naloxone and paracetamol
- Where
- France
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University Hospital, Clermont-Ferrand
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
Drug Overdose Accidental
Addressing Overdose Risk Among Recently Incarcerated People Living With HIV/AIDS
The overall objective of this study is to evaluate an educational overdose prevention intervention's effectiveness among incarcerated people living with HIV/AIDS, specifically within the context of other outcomes related to…
- Trial name
- NCT03569592
- Testing
- Overdose Prevention Intervention
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Drexel University
Harm Reduction, Opioid-use Disorder
A Usability Assessment of Naloxone Administration by Untrained Community Members
This will be a randomized, open-label, usability assessment of intramuscular, intranasal, and nasal spray administration of naloxone using two different instruction sets by laypersons.
- Conditions
- Harm Reduction, Opioid-use Disorder, Naloxone
- Trial name
- NCT04025671
- Testing
- Nasal Spray Naloxone, Intramuscular Naloxone, Improvised Nasal Atomizer
- Where
- United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- State University of New York - Upstate Medical University