Clinical trials: Naloxone
Substance Use, Substance-Related Disorders
Clinician Practice Companion to Address Youth Substance Use
Substance use, including the use of opioids, cannabis, and other drugs, is common among adolescents and young adults, and overdose has become a leading cause of death among youth in Canada and the United States.
- Conditions
- Substance Use, Substance-Related Disorders, Adolescent Substance Use, Cannabis Use
- Trial name
- NCT07725289
- Testing
- Practice Companion
- Where
- 5 sites in United States, Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Drug Overdose
Bioavailability of Nasal Naloxone and Injected Naloxone Compared
Opioid overdoses have in the last decade counted for about 230 untimely deaths annually in Norway. The government is currently implementing a strategy for combating this epidemic.
- Trial name
- OPI-15-002 (NCT02598856)
- Testing
- Intranasal (IN) naloxone 1x, Intranasal (IN) naloxone 2, Intravenous (IV) naloxone
- Where
- Norway
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Norwegian University of Science and Technology
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
Drug Overdose, Opioid-Related Disorders
Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable…
- Trial name
- NCT02572089
- Testing
- Naloxone
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Opioid-use Disorder
Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology
This study will assesses the efficacy of buprenorphine/naloxone vs buprenorphine on maternal withdrawal symptoms and drug cravings.
- Trial name
- NCT03740243
- Testing
- Buprenorphine/naloxone, Buprenorphine
- Volunteers
- healthy volunteers welcome
- Sponsor
- Stony Brook University
Opioid Overdose
Tailoring Overdose Education for Black Churches
Church-based interventions are culturally acceptable, reduce access barriers, and can be brought to scale in under-resourced communities.
- Trial name
- NCT05645016
- Testing
- COEST
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Opioid Induced Respiratory Depression, Chronic Opioid Use
Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists
n this pharmacokinetic/pharmacodynamic modelling study we will determine the ability of intranasal and intravenous naloxone and intravenous nalmefene to reverse opioid (fentanyl and sufentanil)- induced respiratory depression in…
- Trial name
- ROAR (NCT05338632)
- Testing
- Narcan 40 MG/ML Nasal Spray, Naloxone Hydrochloride, Nalmefene HCl injection
- Where
- Netherlands
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
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
Healthy Males
Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function
This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.
- Trial name
- NCT01367561
- Testing
- Naloxone, IV Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Healthy Volunteer
A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers
The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions.
- Trial name
- NCT03827629
- Testing
- Treatment A: Naloxone Nasal Spray, Treatment B: Naloxone Nasal Spray, Treatment C: Naloxone HCL Intramuscular (IM) Injection
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
Healthy
Double Blind Randomized, Monocentric, Cross-over, Placebo-controlled Study to Evaluate the Effect of Morphine and Naloxone on Motivation (MBBAnalgesic)
The aim of the current study is to examine the role of the opioïd system on the cognitive parameters of motivation. They are embedded in a conceptual framework of motivation that merges decision-making and reinforcement learning…
- Trial name
- MBBAnalgesic (NCT02267304)
- Testing
- 50 mL of sodium chloride (0,9%), Morphine 0,05mg/kg, Naloxone 10mg
- Where
- France
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Drug Overdose
Bioavailability 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, twice the annual death toll from traffic accidents.
- Trial name
- NCT02158117
- Testing
- nasal naloxone
- Where
- Norway
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Norwegian University of Science and Technology
Opioid Overdose
Opioid Rapid Response System: Naloxone Training in Communities
The pervasive impact of the opioid epidemic has touched all layers of society for the past two decades, resulting in over 115 deaths daily and imposing annual costs of $78.5 billion.
- Trial name
- NCT06238128
- Testing
- Opioid Rapid Resonse System (ORRS) training, Non-active opioid overdose response training
- Where
- United States
- Volunteers
- 773 people, healthy volunteers welcome
- Sponsor
- University of Missouri-Columbia
Opiate Dependence
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under…
- Trial name
- NCT02477267
- Testing
- SL spray, SL film
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
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
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
Naloxone
Nalox-Comm: Naloxone Communication Training for Pharmacists
This is a pilot Randomized Controlled Trial (RCT) in which 120 pharmacists will be randomized to an experimental or control group and data on naloxone dispensing and secondary outcomes will be collected over the course of the RCT.
- Trial name
- Nalox-Comm (NCT04677387)
- Testing
- Nalox-comm Training Module, Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
Biological Availability
Pharmacokinetics of Fentanyl Following Intravenous and Oral Routes of Administration in Healthy Volunteers
The purpose of the study is to compare the pharmacokinetics of fentanyl following i.v. and oral administration in healthy volunteers, and to assess the bioavailability of fentanyl following oral administration.
- Trial name
- NCT00714558
- Testing
- Fentanyl citrate; Naltrexone; Naloxone
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Alza Corporation, DE, USA
Opioid-Related Disorders
Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone
Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone.
- Trial name
- NCT00000243
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)