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
Chronic Pain
OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients
This is an open-label, randomized, single-dose, parallel group study. The objectives of this study are to assess pharmacokinetics of oxycodone and naloxone from oxycodone/naloxone (OXN) prolonged release (PR) tablet 5/2.5 mg (OXN…
- Trial name
- NCT02880475
- Testing
- OXN PR tablet
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
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
Naloxone
Increasing Naloxone Access for Persons Who Use Opioids
Deaths relating to opioid overdose have rapidly increased over the past two decades. Due to the serious public health concern of the opioid epidemic, federal agencies recommend employing various harm reduction interventions.
- Trial name
- NCT04303000
- Testing
- Opioid Overdose Education with Naloxone Distribution, Opioid Overdose Education
- Where
- 4 sites in United States
- Volunteers
- 111 people
- Sponsor
- University of Alabama at Birmingham
Opiate-related Disorders, Opiate Dependence
Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)
This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®.
- Conditions
- Opiate-related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00684073
- Testing
- buprenorphine, buprenorphine/naloxone
- Volunteers
- 60 people
- Sponsor
- Indivior Inc.
Opioid Overdose, Drug Overdose
Preventing Overdose Using Information and Data From the Environment
The objectives of this project are to leverage surveillance data to predict future overdose outbreaks, and to evaluate the impact of a randomized, statewide, community-level intervention trial to target overdose prevention…
- Trial name
- PROVIDENT (NCT05096429)
- Testing
- PROVIDENT
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Brown University
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
Opioid-Related Disorders, Opiate Dependence
Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life…
- Conditions
- Opioid-Related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00723749
- Testing
- Buprenorphine/Naloxone
- Volunteers
- 384 people
- Sponsor
- Indivior Inc.
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
Opioid-Related Disorders, Opiate Dependence
Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only.
- Trial name
- NCT01848054
- Testing
- Buprenorphine/naloxone sublingual tablets, Buprenorphine
- Where
- 14 sites in United States
- Volunteers
- 313 people
- Sponsor
- Orexo AB
Opioid Dependence
A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants
The primary objective of the study is to demonstrate maintenance of treatment efficacy when transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg or less of sublingual (SL) buprenorphine…
- Trial name
- PRO-814 (NCT02180659)
- Testing
- sublingual buprenorphine tablets, Buprenorphine implant
- Volunteers
- 177 people
- Sponsor
- Titan Pharmaceuticals
Hypogonadotropic Hypogonadism, Low Testosterone
Opioid Antagonism in Hypogonadotropic Hypogonadism
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with hypogonadotropic hypogonadism (HH).
- Trial name
- NCT04975334
- Testing
- Naloxone
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Stephanie B. Seminara, MD
Moderate to Severe Pain Due to Diabetic Polyneuropathy
A Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy
To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.
- Trial name
- NCT00944697
- Testing
- Oxycodone Naloxone
- Where
- Germany
- Volunteers
- 98 people
- Sponsor
- Mundipharma Research GmbH & Co KG
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
Opioid Use Disorder
Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus…
- Trial name
- NCT02032433
- Testing
- Extended-Release Naltrexone, Buprenorphine-Naloxone
- Where
- 8 sites in United States
- Volunteers
- 570 people
- Sponsor
- NYU Langone Health
Opioid Overdose
Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal
The goal of the proposed, proof-of-concept study is to test the combined effects of vaporized marijuana [Delta-9-tetrahydracannabinol (THC)] with NLX as a proof of concept towards the possible development of a combined overdose…
- Trial name
- NCT05114460
- Testing
- Naloxone, Marijuana
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- New York State Psychiatric Institute
Post Operative Pain
OXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty
The purpose of this study is to demonstrate that treatment with OXN PR tablets is non inferior to treatment with OXY PR tablets in terms of analgesic efficacy in patients with postoperative pain after knee arthroplasty based on…
- Trial name
- OXN4505 (NCT01083485)
- Testing
- Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets, Oxycodone
- Where
- Finland
- Volunteers
- 137 people
- Sponsor
- Mundipharma Oy
Opioid-use Disorder, Overdose
Rapid Initiation of Drug Treatment Engagement
The proposed research will evaluate the ability of a mobile, rapid induction procedure to engage individuals in ongoing medication assisted treatment.
- Trial name
- RIDE (NCT03908437)
- Testing
- buprenorphine/naloxone
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- University of Pennsylvania
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