Clinical trials: Naloxone
Opioid Abuse, Overdose
Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders
In the setting of naloxone standing orders, this study will assess if direct outreach with a web-based "Naloxone Navigator 1.0" to patients prescribed chronic opioid therapy (COT) changes opioid risk behaviors, increases naloxone…
- Conditions
- Opioid Abuse, Overdose, Risk Behavior
- Trial name
- NCT03241771
- Testing
- Naloxone Navigator 1.0
- Where
- United States
- Volunteers
- 325 people
- Sponsor
- Kaiser Permanente
Opioid-Related Disorders, Substance-Related Disorders
Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1
The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.
- Trial name
- NCT00015028
- Testing
- Buprenorphine/naloxone
- Where
- United States
- Sponsor
- National Institute on Drug Abuse (NIDA)
Opioid Overdose
Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers
The study consists of two Phases with the first phase (Pilot Phase) divided into two sub phases. In each study phase, subjects will be admitted to the clinical unit from 10 hours prior to the first drug administration on Day -1…
- Trial name
- NCT05363501
- Testing
- IM Naloxone Injection, Naloxone Nasal Spray, Naloxone Nasal Swab
- Where
- Canada
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pocket Naloxone Corp
Subjects With Moderate to Severe, Chronic Nonmalignant Pain
A Randomised, Double Blind, Placebo and Active Controlled, Double Dummy,Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Nonmalignant Pain
The primary objective was to demonstrate the superiority of OXN over placebo over time from the initial dose of study medication to multiple pain events (inadequate analgesia) during the double blind phase.
- Trial name
- NCT01971632
- Testing
- Oxycodone & naloxone combination, prolonged release
- Volunteers
- 463 people
- Sponsor
- Mundipharma Research GmbH & Co KG
Pain
Chronic Low Back Pain and Meditation
The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body…
- Trial name
- NCT04034004
- Testing
- Mindfulness, Naloxone, Saline
- Where
- 2 sites in United States
- Volunteers
- 88 people
- Sponsor
- University of California, San Diego
Buprenorphine, Naloxone
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic…
- Conditions
- Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence
- Trial name
- OPUS R (NCT00723697)
- Testing
- buprenorphine
- Volunteers
- 1,307 people
- Sponsor
- Indivior Inc.
Respiratory Depression
The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine.
This is an investigator led, randomised, double blind, placebo controlled, double arm comparator study.
- Trial name
- NAPRESSIM (NCT02885948)
- Testing
- Naloxone
- Where
- Ireland
- Volunteers
- 96 people
- Sponsor
- University College Dublin
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
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
Opioid Dependency
Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")
Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based…
- Trial name
- RIME (NCT00955162)
- Testing
- Buprenorphine (Subutex), Buprenorphine/naloxone (Suboxone)
- Where
- 20 sites in France
- Volunteers
- 270 people
- Sponsor
- Indivior Inc.
Opioid-Related Disorders
Buprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1
The purpose of this study is to compare two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and treatment as usual, a 7-14 day detoxification…
- Trial name
- NCT00078130
- Testing
- Buprenorphine/naloxone
- Where
- 4 sites in United States
- Volunteers
- 223 people
- Sponsor
- University of Pennsylvania
Opioid Use Disorder
A Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder
The purpose of this study is to evaluate the efficacy; safety and tolerability of ASP8062 compared with placebo ASP8062 as add-on therapy to buprenorphine/naloxone.
- Trial name
- NCT05062577
- Testing
- ASP8062, buprenorphine/naloxone
- Sponsor
- Astellas Pharma Global Development, Inc.
Fentanyl Overdose, Fentanyl Poisoning
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of…
- Trial name
- NCT07459166
- Testing
- Naloxone Hydrochloride, Fentanyl, Sterile Saline
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Clear Scientific, Inc.
Pain, Touch
Sensory and Opioid Mechanisms of Affective Touch
Background: Medicines called opioids are used to treat pain. The body also produces opioids. These are called endorphins. Researchers want to learn more about how these natural opioids work.
- Trial name
- NCT03096353
- Testing
- Naloxone
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- National Center for Complementary and Integrative Health (NCCIH)
Addiction, Opioid Use
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
The overall goal of this project is to collect initial human data on the effects of novel compounds on safety (interactions with an opioid drug, e.g., buprenorphine) and early efficacy signals (subjective effects on negative…
- Conditions
- Addiction, Opioid Use, Substance Use Disorders, Opioid Use Disorder
- Trial name
- NCT05976646
- Testing
- Auvelity
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Virginia Commonwealth University
Opioid-use Disorder
Comparison of Naloxone Pharmacokinetics
Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported…
- Trial name
- NCT03386591
- Testing
- Naloxone, Mucosal atomization device and syringe, Narcan
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Constipation
Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain
The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.
- Trial name
- HMX3501 (NCT00992576)
- Testing
- Active Hydromorphone PR + Active Naloxone PR
- Where
- 14 sites in Australia, Austria and 12 more
- Volunteers
- 600 people
- Sponsor
- Mundipharma Research GmbH & Co KG
Endogenous and Esophageal Sensitivity
The Effect of Naloxone and Methylnaltrexone on Esophageal Sensitivity in Health
The aim of this study was to investigate the effect of naloxone (IV or IM administration) and methylnaltrexone (subcutaneous administration) on esophageal sensitivity, in a group of healthy volunteers in order to evaluate the…
- Trial name
- NCT03014843
- Testing
- Naloxone, Methylnaltrexone Bromide
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Medication Abuse, Harm Reduction
Clinical Decision Support to Improve System Naloxone Co-prescribing
The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions.
- Conditions
- Medication Abuse, Harm Reduction, Opioid Overdose, Opioid Prescribing
- Trial name
- NCT06271668
- Testing
- Naloxone Co-prescribing Clinical Decision Support (CDS)
- Where
- United States
- Volunteers
- 114,272 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Ileus, Fusion of Spine
The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus
Postoperative ileus and opioid induced constipation are well-known post-operative complications. Previously, research has shown that using peripherally acting opioid antagonists can help alleviate the condition.
- Trial name
- FusionIleus (NCT03176316)
- Testing
- Naloxone
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Loyola University