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Opiate 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: NCT05886712 Recruiting - Overdose Clinical Trials

Improving Equitable Access to Naloxone to Prevent Opioid Overdose Deaths Within Syringe Service Programs (SAIA-Naloxone)

SAIA-N
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

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). The main questions it aims to answer are: - Does SAIA-N improve naloxone distribution (number of doses, number of people receiving naloxone) compared to implementation as usual (IAU)? - Does SAIA-N improve equitable naloxone distribution (number of doses to Black, Indigenous, and People of Color (BIPOC) and other sub-groups, number of BIPOC and other sub-groups receiving naloxone) compared to IAU? - What are the costs associated with SAIA-N and how cost-effective is the strategy? SSPs randomized to the SAIA-N arm will participate in the strategy for a period of 12-months during which they will meet 1-2 times each month with a SAIA coach who will assist the SSP in optimizing their naloxone distribution. Researchers will compare SAIA-N to IAU to see if naloxone distribution, equitable naloxone distribution, and costs and cost-effectiveness differ by group.

NCT ID: NCT05665179 Recruiting - Clinical trials for Alcohol Use Disorder

Removing Barriers: Community Partnering for Innovative Solutions to the Opioid Crisis

RB
Start date: December 23, 2021
Phase: N/A
Study type: Interventional

The opioid epidemic has become one of America's deadliest crises, surpassing car crashes, firearms, and HIV/AIDS as a leading cause of death for Americans under fifty years of age. People trying to recover from opioid-use disorder face many obstacles. Obstacles such as minor legal problems (e.g., arrest warrants for failure to pay a fine, failure to appear in court, or late child support payments) can undermine the stability needed to overcome opioid dependence. Outstanding legal obligations make it difficult to find jobs and to secure housing. They can result in removal from treatment programs as well as incarceration. Resolving these legal problems requires coordination, organization, preparation, travel, and time-expectations that may be problematic for many people in the early stages of recovery. Technology has the potential to make resolving these legal problems much easier. Online platform technology is now available that can guide people in recovery through the resolution of many legal problems at no cost and without an attorney, potentially doing so quickly, remotely, and at any time of day. This study of individuals in treatment in Michigan tests whether resolving outstanding legal issues improves drug treatment outcomes. The research also examines whether and to what extent resolving legal issues supports family reunification, reduces future criminal behavior, and improves access to jobs and housing for clients in treatment for opioid use disorder. A randomized controlled trial (RCT) is used to determine the effects of resolving legal issues on these outcomes. For identification, the investigators leverage the random assignment of legal services to treatment center clients, along with the random assignment of clients to treatment centers by birth month. We assemble a novel longitudinal dataset of hundreds of clients in treatment for substance use disorder and link these clients to several administrative datasets and qualitative data, which allows for measurement of: (1) substance use behaviors and (2) justice-system involvement, including civil and criminal legal system encounters. This study also uses linked client and administrative data to research the population in opioid treatment centers, follow-up behaviors, and whether the consequences of providing no-cost legal services differ by client background. Findings from this research will improve America's understanding of the acute socio-legal needs faced by those experiencing opioid use disorder and provide recommendations to help target resources toward the areas that best support long-term abstinence from opioids and other drugs.

NCT ID: NCT05493475 Recruiting - Harm Reduction Clinical Trials

Evaluation of a Novel Intervention to Prevent Polysubstance Overdoses Involving Illicit Stimulants

Start date: November 10, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the feasibility, acceptability, and associated benefits and harms of integrating FTS education and distribution into select courts in rural and urban communities in Ohio.

NCT ID: NCT05463341 Recruiting - Harm Reduction Clinical Trials

Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties

Start date: September 9, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the feasibility, acceptability, and associated benefits and harms of integrating FTS education and distribution into select Project DAWN sites in rural and urban communities in Ohio.

NCT ID: NCT05358132 Recruiting - Clinical trials for Respiratory Insufficiency

ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity

ARM-ED
Start date: June 8, 2022
Phase:
Study type: Observational

There is a drug-related death crisis in Scotland. The majority of these deaths have involved the misuse of opiates (e.g. heroin) and benzodiazepines (e.g. valium) which cause an individual to stop breathing. The Advanced Respiratory Monitoring Events in Drug Toxicity (ARM-ED) study is a study investigating whether a wearable sensor can help detect problems with breathing in patients who have had drugs or medications that may cause this effect. The study will span a year and will study two groups of patients - those who attend with actual or expected respiratory depression secondary to acute drug toxicity and individuals who have undergone procedural sedation and analgaesia in the Emergency Department.

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: NCT04129138 Recruiting - Caregiver Clinical Trials

Patient and Caregiver Attitudes and Beliefs Regarding Prescription of Intranasal Naloxone Spray for Opioid Overdose

Start date: July 18, 2020
Phase:
Study type: Observational

This trial studies the attitudes and beliefs of high risk patients and caregivers regarding the prescription of intranasal naloxone spray for opioid overdose. Knowledge regarding high risk patients' and caregivers' beliefs and attitudes regarding co-prescription of naloxone spray with opioids may help to identify barriers to prescribing and helping tailor the education to better meet the needs of patients and caregivers.