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Opioid Overdose clinical trials

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NCT ID: NCT06005402 Recruiting - Opioid Use Disorder Clinical Trials

Safety, Tolerability, and Pharmacokinetics of CSX-1004

Start date: August 1, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult subjects. The study will have 3 phases: Screening, Inpatient Treatment, and Outpatient Follow-up. The primary objective of the study is to determine the safety and tolerability of CSX-1004 Injection administered by intravenous (IV) infusion across a range of doses in healthy adult subjects. The secondary objective of the study is to determine the pharmacokinetics (PK) of CSX-1004 Injection administered by IV infusion across a range of doses in healthy adult subjects.

NCT ID: NCT05072249 Recruiting - Opioid Overdose Clinical Trials

European Cohort Study of the Effectiveness of Take Home Naloxone

NalPORS
Start date: June 8, 2021
Phase:
Study type: Observational

This study aims to assess the effectiveness of take-home naloxone (THN) to reverse opioid overdose when administered by lay persons in a real world setting. This multicentre, prospective, observational cohort study will be conducted across Europe using a mixed method approach. Recruiting 6000 individuals to whom a supply of THN has been provided, for n=600 to witness an opioid overdose. The co-primary outcomes are to determine the rate of administration of naloxone and frequency of deaths in the 24 hours subsequent to the administration of naloxone. This will be captured through structured interviews with those who report witnessing an opioid overdose in the 6 month study period, approximately n=600, to elicit further information on the overdose and any naloxone administered. Naloxone training materials and education provided will be examined through questions in the structured interview. In-depth qualitative interviews will also be conducted with 60 participants who have witnessed an overdose, in order to better understand the use, safety and effectiveness of different naloxone products (particularly Nyxoid). As part of the qualitative analysis, interview transcripts will be assessed by an expert clinician panel for accuracy of diagnosis, actions taken and aftercare. Routine data from national health registers will be used to gather mortality data. This study will report on the use of different formulations of naloxone. In addition, this study serves as a Post Authorisation Efficacy Study (PAES) for the intranasal (IN) naloxone, Nyxoid developed by MundiPharma and focuses on drug safety and training.

NCT ID: NCT04815590 Recruiting - Opioid-Use Disorder Clinical Trials

Extended-release Injectable Buprenorphine for Individuals at High Risk of Overdose

FASTER-BUP
Start date: October 17, 2022
Phase:
Study type: Observational [Patient Registry]

This pilot study will evaluate the feasibility and clinical utility of extended-release injectable buprenorphine (XR-BUP) for the treatment of opioid use disorder (OUD) among individuals at high-risk for overdose (OD).

NCT ID: NCT04811014 Recruiting - Opioid Use Clinical Trials

Young Houston Emergency Opioid Engagement System

YHEROES
Start date: April 19, 2021
Phase: Phase 4
Study type: Interventional

The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a community-based research program integrating assertive outreach, medication for opioid use disorder (MOUD), behavioral counseling, and peer recovery support. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder. The investigators also intend to understand the prevalence of opioid overdoses and OUD among youth in Houston.

NCT ID: NCT03968237 Recruiting - Opioid Overdose Clinical Trials

Measures to Improve Outcomes After an Opioid Overdose

Start date: August 1, 2019
Phase:
Study type: Observational

This is a pilot study that aims to develop good clinical practices to improve outcomes after an opioid overdose and transition of care from the Emergency Department (ED) into an Office Based Opioid Treatment (OBOT) clinic for patients with opioid overdose/Opioid Use Disorder (OUD). We intend to involve UVA Emergency Medicine and Medical Toxicology physicians with buprenorphine waiver or an interest in becoming waived at our institution to implement early initiation of buprenorphine protocol. We hope that this change in practice will result in better management of patients with OUD and opioid overdose, reduce relapse and improve engagement in addiction treatment. Subjects who meet criteria will be consented in the ED and receive a buprenorphine/naloxone induction protocol, prior to discharge and referral to the OBOT clinic. Subjects who consent to take part in this study will be entered in a database to track their involvement in treatment (s) at UVA and or any opioid related UVA health visits including OPIOID OVERDOSE.

NCT ID: NCT03924505 Recruiting - Opioid Overdose Clinical Trials

Preventing Opioid Overdose Mortality in the United States

Start date: September 3, 2019
Phase: N/A
Study type: Interventional

This study aims to generate knowledge regarding the process of implementing naloxone within syringe service programs (SSPs), and to test whether external facilitation can improve implementation of naloxone within SSPs throughout the country. Together, these efforts can improve access to naloxone for people at high risk of overdose, thereby improving our nation's response to the opioid overdose epidemic.