Clinical trials: Naloxone
Overdose, Implementation as Usual
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
The goal of this clinical trial is to compare the effectiveness of a multi-faceted implementation strategy, the Systems Analysis and Improvement Approach for Naloxone (SAIA-N), in syringe service programs (SSPs).
- Trial name
- SAIA-N (NCT05886712)
- Testing
- Naloxone, Usual intervention
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- RTI International
Opioid-use Disorder, Pain, Acute
Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use
The aim of this study is to determine the effect of continuation of buprenorphine/naloxone in patients with history of Opioid Use Disorder (OUD) scheduled for surgery compared to reduced dose buprenorphine/naloxone prior to…
- Conditions
- Opioid-use Disorder, Pain, Acute, Surgery
- Trial name
- NCT03266445
- Testing
- buprenorphine/naloxone
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Postoperative Pain, Opioid Related Disorders
A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery.
- Trial name
- NCT01374763
- Testing
- Oxycodone, Prolonged-release oxycodone/naloxone
- Where
- Finland
- Volunteers
- 165 people
- Sponsor
- Kati Järvelä
Pain
Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain
The main objective of the study is to evaluate the patient preference for pain treatment with respect to quality of life in patients with moderate to severe non malignant pain.
- Trial name
- NCT01167699
- Testing
- Oxycodone and naloxone
- Where
- Belgium
- Volunteers
- 174 people
- Sponsor
- Mundipharma Pharmaceuticals B.V.
Opioid Overdose
Tailoring Overdose Education for Black Churches
Church-based interventions are culturally acceptable, reduce access barriers, and can be brought to scale in under-resourced communities.
- Trial name
- NCT05645016
- Testing
- COEST
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Hip Arthroplasty, Knee Arthroplasty
Effect of Combined Use of Naloxone and Tramacet on Postop Analgesia in Elderly Patients Having Joint Replacement Surgery
Patients over 70 years of age, scheduled for joint replacement surgery will be randomized to tramacet/ naloxone plus morphine PCA or to morphine PCA to assess quality of analgesia in the postoperative period.
- Conditions
- Hip Arthroplasty, Knee Arthroplasty, Spinal Anesthesia
- Trial name
- NCT00679614
- Testing
- tramacet, naloxone, tramacet, Acetaminophen
- Where
- Canada
- Volunteers
- 45 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Pharmacies, Opioid Use
RESPOND TO PREVENT: Stepwise Pharmacy Naloxone Study
This multi-site study will test the efficacy of an intervention to train and equip pharmacists to provide naloxone, an overdose antidote, to patients using prescribed and illicit opioids, to improve opioid safety and prevent…
- Conditions
- Pharmacies, Opioid Use, Patient Safety
- Trial name
- NCT03545321
- Testing
- MOON+
- Where
- 5 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Brandeis University
Central Nervous System Sensitization, Pain
Effect of High-dose Naloxone Infusion on Pain and Hyperalgesia in Patients Following Groin-Hernia Repair.
Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache.
- Conditions
- Central Nervous System Sensitization, Pain, Hyperalgesia
- Trial name
- NCT01992146
- Testing
- Target-controlled naloxone-infusion
- Where
- Denmark
- Volunteers
- 9 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Opioid-Related Disorders, Behavior, Addictive
Adolescent Community Reinforcement Approach in Combination With Buprenorphine/Naloxone for Severe Opioid Use
The study assesses whether adding a behavioral intervention, known as the Adolescent Community Reinforcement Approach (A-CRA), to the treatment of individuals already receiving buprenorphine/naloxone can improve treatment success…
- Trial name
- A-CRA/MAT (NCT03287180)
- Testing
- Adolescent Community Reinforcement Approach (A-CRA), Combination of buprenorphine/naloxone 4/1
- Sponsor
- Emory University
Opiate Dependence
Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan
To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with opiate dependence.
- Trial name
- NCT00901875
- Testing
- Buprenorphine + naloxone (Suboxone)
- Where
- 8 sites in Taiwan
- Volunteers
- 127 people
- Sponsor
- Indivior Inc.
Healthy Subjects, Opioid Antagonist
Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone
Intranasal (IN) naloxone is available as 2 mg or 4 mg dose with the indication to re-administer additional doses every 2 to 3 minutes (using alternating nostrils) if needed until emergency medical assistance arrives.
- Conditions
- Healthy Subjects, Opioid Antagonist, Pharmacokinetics
- Trial name
- NCT04764630
- Testing
- Four naloxone nasal spray doses (1 every 2.5 min), Four naloxone nasal spray doses (2 every 2.5 min), Two naloxone nasal spray doses (1 every 2.5 min)
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Healthy Volunteer
A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers
The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions.
- Trial name
- NCT03827629
- Testing
- Treatment A: Naloxone Nasal Spray, Treatment B: Naloxone Nasal Spray, Treatment C: Naloxone HCL Intramuscular (IM) Injection
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
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
Pain, Nausea
Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents
This is an investigator initiated dose finding study designed to determine the optimal dose of naloxone to prevent or minimize the most common side effects induced by opioids, namely itching, nausea, and vomiting.
- Conditions
- Pain, Nausea, Pruritus
- Trial name
- NCT00330343
- Testing
- naloxone
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Johns Hopkins University
Post-Op Complication
a Small Dose of Naloxone,Minimize Intrathecal Morphine Side Effects
I.V naloxone decreases incidence and severity of the common morphine side effects (pruritis, nausea/emesis, constipation, urinary retention, respiratory depression and undesirable sedation) so using it as additive to intrathecal…
- Trial name
- NCT03230474
- Testing
- Morphine, Morphine-Naloxone
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Assiut University
Opiate Dependence, HIV Seropositivity
Comparison of HIV Clinic-based Treatment With Buprenorphine Versus Referred Care in Heroin-dependent Participants
The purpose of this study is to compare the effectiveness of two approaches to treating HIV-infected patients who are addicted to opioid drugs (e.g., heroin) in an inner-city HIV clinic.
- Conditions
- Opiate Dependence, HIV Seropositivity, HIV Infections
- Trial name
- NCT00130819
- Testing
- Clinic-based substance abuse treatment with buprenorphine, Case management and referred substance abuse treatment
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Johns Hopkins University
Opioid Tolerance, Pain
Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients
When narcotic pain medicine, like fentanyl or morphine, is given to adults and children for several days, they often develop a tolerance to the medicine.
- Trial name
- NCT00669175
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Children's Mercy Hospital Kansas City
Harm Reduction
BE Intervention for Naloxone Uptake
The overall objective of this study is to use behavioral economics interventions to increase naloxone acquisition and carrying among participants who attend an opioid overdose reversal training.
- Trial name
- NCT06064981
- Testing
- Text message nudges, Commitment contract
- Where
- 2 sites in United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Hepatitis C
Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to…
- Trial name
- NCT01637922
- Testing
- BI 201335
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Boehringer Ingelheim
Opioid Dependence, Opioid Intoxication
Naloxone to TReatment Entry in the Emergency Setting
The study tests a structured referral process for opioid overdose survivors, from pre-hospital emergency care to long-term treatment of the individual's substance use-related disorder.
- Conditions
- Opioid Dependence, Opioid Intoxication, Substance Use Disorders
- Trial name
- N-TREE (NCT03368794)
- Testing
- Active treatment referral of opioid overdose survivors to long-term treatment, Control
- Where
- Sweden
- Sponsor
- Anders C Håkansson