Clinical trials: Naloxone
Opioid Use Disorder (OUD)
HEALing Communities Study
This study will test the impact of implementing the Communities That Helping to End Addiction Long-term (HEAL) intervention on opioid overdose deaths within 67 highly affected communities with the goal of reducing opioid overdose…
- Trial name
- NCT04111939
- Testing
- Communities That HEAL, Wait-list control
- Where
- 4 sites in United States
- Volunteers
- 67 people
- Sponsor
- RTI International
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 Use Disorder, Opioid Use
Novel Induction to Buprenorphine/Naloxone
Microdosing induction is a novel method of starting buprenorphine/naloxone without patients experiencing the opioid withdrawal that is a part of traditional induction.
- Conditions
- Opioid Use Disorder, Opioid Use, Opioid Abuse, Opioid Misuse
- Trial name
- NCT05644587
- Testing
- buprenorphine/naloxone
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Bicycle Health
Carrying Naloxone/Narcan on Their Person or in Their Vehicle, Being Trained to Respond to an Opioid Overdose
The Feasibility of Using the PulsePoint to Facilitate Overdose Education and Naloxone Distribution
This study is a feasibility trial to assess whether, in a random sample of 180 agencies where PulsePoint is already active, revised procedures (hereinafter PulsePoint-OD) to facilitate opioid overdose and naloxone distribution…
- Trial name
- PP-OD (NCT06523985)
- Testing
- Push messages (standard), Push messages (customized)
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Indiana University
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
Opioid Abuse
Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
Death in overdose is the single most common cause of death in people using heroin. In Sweden, the number of drug-related overdose deaths has increased gradually since the early 1990s.
- Trial name
- NCT03570099
- Testing
- Naloxone Nasal Spray, Historical control cohort
- Where
- Sweden
- Volunteers
- 2,000 people
- Sponsor
- Region Skane
Overdose
Evaluation of a Medication Health Center to Promote Opioid Safety
This study will assess the impact of an opioid safety clinic intervention for patients prescribed chronic opioid therapy. Outcomes are visits to the clinic, naloxone dispensings, Prescription Drug Monitoring reviews, and Urine…
- Trial name
- NCT06456294
- Testing
- MHC Outreach Intervention
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Kaiser Permanente
Opioid-Use Disorder (OUD)
SafetyNet Program for Opioid Use Disorder (OUD)
The principal aim of this study is to determine whether a novel biopsychosocial intervention following opioid overdose (OD) affects 1) the frequency of secondary opioid OD events and 2) the proportion of individuals who remain…
- Trial name
- NCT04253782
- Testing
- Team Intervention
- Where
- 2 sites in United States
- Volunteers
- 81 people
- Sponsor
- Yale 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
Opioid Overdose
Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
Objectives: The purpose of this study was to assess the impact of the Empowering Community Pharmacists program on pharmacists' knowledge, perceived barriers, attitudes, confidence, and intentions regarding naloxone services…
- Trial name
- NCT05093309
- Testing
- Educational Webinar, Resources, Reminders
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Auburn University
Harm Reduction, Naloxone
Vending Machine Naloxone Distribution for Your Community (VENDY)
Vending machines are an innovative strategy shown to increase access to naloxone, a medication used to reverse opioid overdose. The aim of this proposal is to study the reach of a community-initiated, stakeholder engaged…
- Conditions
- Harm Reduction, Naloxone, Opioid Overdose
- Trial name
- NCT06429436
- Testing
- VENDY
- Where
- 3 sites in United States
- Volunteers
- 4,000 people
- Sponsor
- University of Colorado, Denver
Hepatitis C Virus
A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)
In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will be given boceprevir. Blood samples will be taken at specified intervals to find out whether boceprevir affects the pharmacokinetics of…
- Trial name
- NCT01396005
- Testing
- boceprevir, methadone, buprenorphine/naloxone
- Volunteers
- 21 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Osteoarthritis
OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects
The primary objectives are to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor function.
- Trial name
- NCT00902837
- Testing
- Oxycodone naloxone prolonged release tablets (OXN), oxycodone prolonged release tablet, oxycodone naloxone tablet
- Where
- 36 sites in Belgium, Czechia and 4 more
- Volunteers
- 181 people
- Sponsor
- Mundipharma Research GmbH & Co KG
Heroin Dependence, Opioid Use Disorder
Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence
This research deals with behaviors that are part of opioid dependence. The purpose is to study how stress and medication dose can affect opioid drug use.
- Trial name
- BOS (NCT03015246)
- Testing
- Extended release morphine, Buprenorphine/Naloxone low dose, Buprenorphine/Naloxone moderate dose
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Wayne State University
Opiate Dependence, Human Immunodeficiency Virus
Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
To address the question of the comparison of two courses of Vivitrol with differing lengths in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient treatment.
- Trial name
- NCT01882361
- Testing
- injectable naltrexone
- Where
- Russia
- Volunteers
- 77 people
- Sponsor
- University of Pennsylvania
Opioids; Harmful Use
Piloting a Naloxone Intervention in Philadelphia
The escalating opioid overdose epidemic is one of the most serious public health problems confronting the U.S. Death due to drug overdose is a significant and rising cause of mortality and morbidity in Philadelphia.
- Trial name
- NCT03305497
- Testing
- Mobile Phone Application
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Drexel University