Clinical trials: Naloxone
Healthy
Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers.
This is a phase I interventional clinical trial and the aim will be to characterize the PK and PD of two formulations of naloxone (intranasal and intravenous) in healthy subjects, which will be used to verify/validate…
- Trial name
- NCT06306391
- Testing
- Intravenous naloxone, Intranasal naloxone
- Where
- 2 sites in Spain
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Parc de Salut Mar
Low Back Pain
Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid…
- Trial name
- NCT01358526
- Testing
- Oxycodone/Naloxone Controlled-release
- Where
- 151 sites in United States
- Volunteers
- 1,095 people
- Sponsor
- Purdue Pharma LP
Opioid Use
Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films
While substance use disorders have been found to have relapse rates on part with other chronic illnesses such as hypertension and asthma long term abstinence remains elusive for many.
- Trial name
- NCT03744663
- Testing
- Suboxone® SL, Sublocade®
- Sponsor
- Wake Forest University Health Sciences
Hypoglycemia Unawareness, Type 1 Diabetes
Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia
This is a single center, single-blind randomized cross over design trial that will compare the impact of intra-nasal naloxone vs.
- Trial name
- NCT02700048
- Testing
- intra-nasal naloxone, Intra-nasal saline
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Overdose, Risk Behavior
The Impact of a Web-Based Naloxone Intervention Under Standing Orders to Patients Prescribed Chronic Opioid Therapy
In the setting of naloxone standing orders, this study will assess the impact of a targeted, web-based overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy.
- Trial name
- NCT03337009
- Testing
- Naloxone Navigator (NN)
- Where
- United States
- Volunteers
- 1,004 people
- Sponsor
- Kaiser Permanente
Opioid-Related Disorders
Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence
Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine.
- Trial name
- NCT00134914
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Healthy
A Single-Dose Study of an Investigational Capsule Formulation of 2 mg/0.5 mg Buprenorphine/Naloxone
A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg Buprenorphine/Naloxone. NIDA Contract No. HHSN271200577414C
- Trial name
- NCT00880841
- Testing
- Buprenorphine / Naloxone
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- NanoSHIFT LLC
Infection, Human Immunodeficiency Virus
A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone
The study is being conducted to assess the effect of multiple doses of BMS-663068 on the exposure of methadone in subjects on a stable dose of methadone, and the exposure of buprenorphine and norbuprenorphine in subjects on a…
- Trial name
- NCT02666001
- Testing
- BMS-663068, Methadone, Buprenorphine and Norbuprenorphine
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- ViiV Healthcare
Dry Eye Syndromes, Neuropathic Pain
Topical Naloxone to Diagnose Ocular Pain
Chronic ocular neuropathic pain may be misdiagnosed as dry eye disease. Our study aims to identify a population with previous monocular trauma and dry eye symptoms and differentiate neuropathic from dry eye pain using topical…
- Trial name
- NCT04454281
- Testing
- Naloxone Hydrochloride 0.4 MG/ML
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Seema Capoor
Opiate Dependence, Substance-related Disorders
Prescription Opioid Addiction Treatment Study (POATS)
The purpose of this study is to determine whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphine/naloxone with…
- Conditions
- Opiate Dependence, Substance-related Disorders, Opioid-related Disorders
- Trial name
- NCT00316277
- Testing
- Standard Medical Management (SMM) of Prescription Opiate Abuse, Enhanced Medical Management (EMM) of Prescription Opiate Abuse
- Where
- 12 sites in United States
- Volunteers
- 653 people
- Sponsor
- Mclean Hospital
Hepatitis C, Opioid-Related Disorders
Drug-Drug Interaction Study Between Telaprevir and Buprenorphine
The purpose of this study is to investigate the drug-drug interaction potential between telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will help to determine whether buprenorphine dose…
- Trial name
- NCT01275599
- Testing
- telaprevir, buprenorphine/naloxone
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Opioid Overdose
Blood Naloxone Levels Following Intradermal Injection in Humans
The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics of intradermal administration of naloxone in healthy adult subjects.
- Trial name
- NCT05876572
- Testing
- intradermal naloxone, microneedle injection
- Volunteers
- healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Drug Overdose
A Pilot Study of the Bioavailability of Nasal Naloxone
The overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone.
- Trial name
- NCT01939444
- Testing
- naloxone intranasal, naloxone intravenous
- Where
- Norway
- Volunteers
- 5 people
- Sponsor
- Norwegian University of Science and Technology
Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous
Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis…
- Conditions
- Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous, Sézary Syndrome
- Trial name
- NCT02811783
- Testing
- Naloxone Hydrochloride Lotion, 0.5%
- Where
- 16 sites in United States
- Volunteers
- 59 people
- Sponsor
- Elorac, Inc.
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)
Pain
The Effect of Ultra-low-dose Naloxone on Remifentanil-induced Postoperative Hyperalgesia - A Randomized Controlled Study
High-dose remifentanil infused intraoperative ironically results in postoperative hyperalgesia. Ultra-low dose nalxone is demonstrated to prevent these opioid-induced hyperalgesia in animal model.
- Trial name
- NCT02856087
- Testing
- High dose Remifentanil, Naloxone, Low dose remifentanil
- Where
- South Korea
- Volunteers
- 92 people
- Sponsor
- Seoul National University Hospital
Overdose, Drug Abuse
Naloxone Nasal Spray Compared With Naloxone Injection for Opioid Overdoses Outside the Hospital
This trial will compare the clinical response to intramuscular and intranasal naloxone in pre-hospital opioid overdoses. Objective of the study is to measure and evaluate clinical response (return of spontaneous respiration…
- Trial name
- NINA-1 (NCT03518021)
- Testing
- Naloxone, intranasal, Naloxone, intramuscular
- Where
- 2 sites in Norway
- Volunteers
- 286 people
- Sponsor
- Norwegian University of Science and Technology
Opiate Substitution Treatment
Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence
This is a randomized trial of two group-based models of care for buprenorphine/naloxone (bup/nx) patients in Substance Use (SU) specialty treatment: Standard Medical Management (SMM) and Intensive Outpatient Treatment (IOT).
- Trial name
- NCT02496403
- Testing
- Standard Medical Management (SMM)
- Where
- United States
- Volunteers
- 239 people
- Sponsor
- Kaiser Permanente
Pruritis
Effect of Intrathecal Naloxone in the Incidence of Pruritis After C.S
This randomized prospective double-blind trial will be conducted on 80 Full-term pregnant females aged 21- 30 years presented for elective cesarean section under spinal anesthesia where they will be randomly allocated into two…
- Trial name
- NCT04518618
- Testing
- Fentanyl, Naloxone
- Where
- 2 sites in Egypt
- Volunteers
- 96 people
- Sponsor
- Tanta University
Pain
Reversal of Ketamine Pharmacodynamic Effects With Naloxone
The purpose of this study is to determine whether the analgetic and other effects effect of ketamine are partly mediated through opioid receptors
- Trial name
- NCT00921765
- Testing
- Saline, Saline + Ketamine, Naloxone + Ketamine
- Where
- Norway
- Volunteers
- 3 people
- Sponsor
- Ullevaal University Hospital