Clinical trials: Naloxone
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
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
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
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
Opioid-Related Disorders
Safety and Tolerability of Buprenorphine/Naloxone Film Strips
This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a…
- Trial name
- NCT00640835
- Testing
- Buprenorphine/naloxone Film Strip
- Where
- 3 sites in United States
- Volunteers
- 382 people
- Sponsor
- Indivior Inc.
Opioid Dependence
Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
The primary objective of this study is to compare overall patient preference for either Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4.
- Trial name
- NCT02038790
- Testing
- Suboxone Sublingual Film, Zubsolv sublingual tablets
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Indivior 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
Opioid Dependence, on Agonist Therapy
Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent…
- Trial name
- NCT01903005
- Testing
- Higher bioavailability BNX sublingual tablets
- Where
- 28 sites in United States
- Volunteers
- 668 people
- Sponsor
- Orexo AB
Constipation, Pain
Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients
The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced…
- Trial name
- OXN3505 (NCT01014559)
- Testing
- Oxycodone Naloxone, Oxycodone PR Tablets
- Where
- France
- Volunteers
- 225 people
- Sponsor
- Mundipharma SAS
Cancer
A Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
A multicenter, phase IV, interventional study to assess the efficacy and safety of Targin (Oxycodone/Naloxone) Korean patients with CIPN (Chemotherapy-Induced Peripheral Neuropathy) who need opioid combination treatment with…
- Trial name
- NCT01675531
- Testing
- Targin
- Where
- South Korea
- Volunteers
- 73 people
- Sponsor
- Mundipharma Korea Ltd
Pain
Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation
The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.
- Trial name
- NCT00412100
- Testing
- Oxycodone naloxone prolonged release tablets (OXN)
- Sponsor
- Mundipharma Research GmbH & Co KG
Pain
Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain
The main objective of the study is to observe the OXN treatment of patients with moderate to severe non-malignant pain in daily clinical practise with respect to pain relief and bowel function.
- Trial name
- NCT01167127
- Testing
- Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release
- Where
- Netherlands
- Volunteers
- 113 people
- Sponsor
- Mundipharma Pharmaceuticals B.V.
Low Back Pain
A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects…
- Trial name
- NCT01427283
- Testing
- Oxycodone/Naloxone controlled-release, Oxycodone HCl controlled-release
- Where
- 149 sites in United States
- Volunteers
- 450 people
- Sponsor
- Purdue Pharma LP
Opioid Use Disorder
A Study of Brenipatide in Participants With Opioid Use Disorder
The purpose of this study is to see if brenipatide, when compared to placebo, is safe and effective for participants with opioid use disorder, when used with buprenorphine with or without naloxone.
- Trial name
- RENEW-Op-1 (NCT07420283)
- Testing
- Brenipatide, Buprenorphine
- Where
- 61 sites in United States, Canada and 2 more
- Volunteers
- 465 people
- Sponsor
- Eli Lilly and Company
Opioid Dependence
The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects
A randomized, double blind, active controlled study in approximately 40 opioid dependent subjects. Study duration is up to five days and includes a maximum of 3 days confinement in the clinic.
- Trial name
- NCT02516436
- Testing
- BEMA Buprenorphine NX, Buprenorphine
- Where
- 3 sites in United States
- Sponsor
- BioDelivery Sciences International
Opiate Addiction, Medication Non-adherence
Using Artificial Intelligence To Monitor Medication Adherence in Opioid Replacement Therapy
This study uses an artificial intelligence platform to automatically confirm medication ingestion. The Health Insurance Portability and Accountability Act (HIPAA)-compliant platform can be downloaded as an 'app' onto any…
- Conditions
- Opiate Addiction, Medication Non-adherence, Addiction, Opioid Dependence
- Trial name
- NCT02243670
- Testing
- AiCure monitoring and intervention
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- AiCure
Opioid-use Disorder
Improving Office Based Treatment of Opioid Use Disorder With Technology
The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve…
- Trial name
- NCT03586466
- Testing
- BupreCare, Buprenorphine/naloxone, MEMS
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- MedicaSafe, Inc.
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
Interstitial Cystitis, Painful Bladder Syndrome
OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects suffering from severe pain due to Bladder Pain Syndrome.
- Conditions
- Interstitial Cystitis, Painful Bladder Syndrome, Pain
- Trial name
- NCT01197261
- Testing
- Oxycodone naloxone prolonged release tablets
- Where
- 5 sites in Czechia, Germany and 3 more
- Volunteers
- 120 people
- Sponsor
- Mundipharma Research GmbH & Co KG