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
Reproductive Disorders
Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in healthy subjects.
- Trial name
- NCT04975347
- Testing
- Naloxone
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Stephanie B. Seminara, MD
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
Opioid-related Disorders
Abuse Liability of Suboxone Versus Subutex
The study is designed to compare the abuse liabilities of intravenous buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine.
- Trial name
- NCT00710385
- Testing
- Heroin, Naloxone, Low Bup Dose
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Healthy, Opioid Use Disorder
Multi-System Analysis of Opioid Receptor Binding
This study will enroll up to 60 adults (including 30 females and 30 males) in three cohorts of up to 20 subjects each. In all three groups, [11C]carfentanil whole-body PET imaging will be used to examine the central nervous…
- Trial name
- NCT05528848
- Testing
- Carfentanil, C-11, Naloxone, Loperamide Hydrochloride
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Drug Overdose
A Usability Assessment of Naloxone by Community Members
This will be a usability trial to assess administration of naloxone via intramuscular, atomized intranasal, and nasal spray routes by nonmedical community members.
- Trial name
- NCT03309449
- Testing
- Syringe and needle, Intranasal mucosal atomization device, Nasal spray
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- State University of New York - Upstate Medical 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
Gambling, Opioid
Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray
Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. Brief intervention.
- Conditions
- Gambling, Opioid, Naloxone, Spray
- Trial name
- NALPILO (NCT03223896)
- Testing
- Naloxone hydrochloride 20mg/ml
- Where
- Finland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Finnish Institute for Health and Welfare
HIV Infections
Pharmacokinetic Interactions Between Buprenorphine and Tipranavir/Ritonavir
The main purpose of this study is to examine the effect of tipranavir combined with ritonavir, medications for the treatment of HIV-infection, on buprenorphine/naloxone (BUP) in people who have been receiving the same dose of…
- Trial name
- BUTI (NCT00486330)
- Testing
- Buprenorphine, Tipranavir and ritonavir
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Yale University
Opioid Overdose
A Model to Save Lives Through a Volunteer First Responder Service Providing Antidote Treatment in Opioid Overdose
Opioids are responsible for the greatest drug-related global health burden. Prevention and treatment programs for people with opioid use disorder are widely implemented, but further actions are required to reduce the mortality…
- Trial name
- RESPONDER (NCT07079241)
- Testing
- Naloxone-responder: A volunteer first responder system connected to emergency dispatch service and alerting overdose and first aid educated volunteers with naloxone to suspected opioid overdoses
- Where
- Sweden
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Region Skane
Pharmacies, Opioid Use
RESPOND TO PREVENT: Stepwise Pharmacy Naloxone Study
This multi-site study will test the efficacy of an intervention to train and equip pharmacists to provide naloxone, an overdose antidote, to patients using prescribed and illicit opioids, to improve opioid safety and prevent…
- Conditions
- Pharmacies, Opioid Use, Patient Safety
- Trial name
- NCT03545321
- Testing
- MOON+
- Where
- 5 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Brandeis University
Opioid Use, Opioid-Related Disorders
Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER)
Among people at risk of opioid overdose and receiving care in an academic emergency department, family practice, opioid substitution clinic or general inpatient units, does brief opioid overdose resuscitation training and…
- Conditions
- Opioid Use, Opioid-Related Disorders, Opioid Withdrawal, Opioid Overdose
- Trial name
- SOONER (NCT04740099)
- Testing
- SOONER Video & Kit, Standard of Care
- Where
- Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- Unity Health Toronto
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
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
Pain
Subjective Analgesic Effects of Naloxone and Virtual Reality
This study is designed to test a specific hypothesis exploring the neurophysiologic mechanism(s) that underlie the pain- relieving effects of immersive Virtual Reality (VR) as a non-pharmacologic pain management technique, using…
- Trial name
- Narcan (NCT01105871)
- Testing
- naloxone
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Washington
Drug Overdose
Pharmacodynamics and Arteriovenous Differences of Naloxone in Healthy Participants Exposed to an Opioid
Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required.
- Trial name
- OPI-15-001 (NCT02405988)
- Testing
- Intravenous naloxone, Remifentanil
- Where
- Norway
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Norwegian University of Science and Technology
Overdose, Implementation as Usual
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
The goal of this clinical trial is to compare the effectiveness of a multi-faceted implementation strategy, the Systems Analysis and Improvement Approach for Naloxone (SAIA-N), in syringe service programs (SSPs).
- Trial name
- SAIA-N (NCT05886712)
- Testing
- Naloxone, Usual intervention
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- RTI International
Healthy Subjects, Opioid Antagonist
Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone
Intranasal (IN) naloxone is available as 2 mg or 4 mg dose with the indication to re-administer additional doses every 2 to 3 minutes (using alternating nostrils) if needed until emergency medical assistance arrives.
- Conditions
- Healthy Subjects, Opioid Antagonist, Pharmacokinetics
- Trial name
- NCT04764630
- Testing
- Four naloxone nasal spray doses (1 every 2.5 min), Four naloxone nasal spray doses (2 every 2.5 min), Two naloxone nasal spray doses (1 every 2.5 min)
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Opioid-Related Disorders
Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users
Buprenorphine is a medication used to treat opioid addiction, but individuals who use this drug are at risk of abusing it. A buprenorphine and naloxone combination may reduce the likelihood of buprenorphine addiction.
- Trial name
- NCT00158236
- Testing
- Buprenorphine, Buprenorphine and Naloxone, Hydromorphone
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Opioid-use Disorder
Evaluation of Intranasal Naltrexone and Naloxone
This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.
- Trial name
- NCT03851731
- Testing
- Naltrexone, Naloxone, Naltrexol
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)