Clinical trials: Naloxone
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
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
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
Opioid-related Disorders
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active…
- Trial name
- NCT00637000
- Testing
- Buprenorphine soluble film, Buprenorphine/naloxone film strip
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Indivior Inc.
Opioid Dependence, on Agonist Therapy
Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared…
- Trial name
- ISTART (NCT01908842)
- Testing
- BNX sublingual tablets, BNX sublingual film, Buprenorphine
- Where
- 36 sites in United States
- Volunteers
- 759 people
- Sponsor
- Orexo AB
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 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
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 Disorder
OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC)…
- Trial name
- NCT04948307
- Testing
- OXD01 digital therapy, Standard of Care
- Where
- 21 sites in United States
- Volunteers
- 437 people
- Sponsor
- Orexo AB
Opioid-Related Disorders, Opiate Dependence
Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing.
- Conditions
- Opioid-Related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00725608
- Testing
- buprenorphine/naloxone
- Where
- Austria
- Volunteers
- 339 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
Pain, Postoperative, Postoperative Nausea and Vomiting
Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose.
- Conditions
- Pain, Postoperative, Postoperative Nausea and Vomiting, Scoliosis
- Trial name
- NCT01531439
- Testing
- Naloxone
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Children's Mercy Hospital Kansas City
Opioid Use Disorder
A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder
The primary purpose of this study was to assess the safety and tolerability of multiple doses of buprenorphine/naloxone alone and buprenorphine/naloxone in combination with a single dose of ASP8062.
- Trial name
- NCT04447287
- Testing
- ASP8062, buprenorphine/naloxone
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Cancer
A Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone Compared to OxyContin in Korean Cancer Patients
Objectives: To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity 1. Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours obtained each evening) within 4…
- Trial name
- TOP (NCT01313780)
- Testing
- Oxycodone/Naloxone, Oxycodone(single compound)
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- Mundipharma Korea Ltd
Hyperalgesia
Effect of Ultra-low Dose Naloxone on Remifentanil-Induced Hyperalgesia
The purpose of this study is to evaluate whether using ultra-low dose naloxone, an opioid antagonist, has the potential to block remifentanil-induced hyperalgesia and tolerance following surgery.
- Trial name
- NCT03066739
- Testing
- Remifentanil, Remifentanil +ultra-low dose naloxone
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of California, Irvine
Chronic Pruritus
Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone
The purpose of this study is to assess the efficacy and safety of sublingual naloxone in the treatment of chronic itch in patients under arsenic exposure.
- Trial name
- NCT03751111
- Testing
- Naloxone
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Xiangya Hospital of Central South University
Chronic Pain, Opioid Induced Constipation
Naloxone SR Capsules in Patients With Opioid Induced Constipation
For many patients taking opioids for pain relief one of the most distressing side effects is constipation. Naloxone is effective in the reversal of the effects of opioids and is used following opioid overdose.
- Trial name
- NCT00984334
- Testing
- Naloxone SR 5 mg capsules, Naloxone SR 10 mg capsules, Naloxone SR 20mg capsules
- Where
- 8 sites in Germany, United Kingdom
- Volunteers
- 40 people
- Sponsor
- S.L.A. Pharma AG
Opioid-use Disorder
Mobile Medication Adherence Platform for Buprenorphine-Naloxone During Treatment of Opioid Use Disorder: Phase I Study
The investigators will conduct a phase I study involving 41 participants selected randomly among patients prescribed buprenorphine-naloxone for opioid misuse as a feasibility trial of the study of the Pillsy device.
- Trial name
- MAP4BUP (NCT04656899)
- Testing
- Reminders messages to improve adherence.
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Washington State University
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)
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