Active clinical trials for "Drug Overdose"

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).

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.

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.

REBOOT is a randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients with opioid use disorder. It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the efficacy of REBOOT vs attention-control.

This study will examine if the use of a smartphone application called Thrive4Life Connect can help people who use drugs lower their risk of overdose and learn more about COVID-19 vaccines. 60 participants will be enrolled and can expect to be on study for up to 6 months.

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 programs to neighborhoods at highest risk of future overdose deaths. This study develops and tests an opioid overdose forecasting tool, which will allow other states to identify and deploy interventions to communities at highest risk of opioid-related death. The findings from this study have the potential to significantly improve the allocation of resources to curb the opioid overdose epidemic in the United States.

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.

There is a drug-related death crisis in Scotland. This study aims to collaborate with Public Health Scotland in order to assess the feasibility of introducing a surveillance system to the Emergency Department to highlight illicit drug-related attendances. This will utilise both clinical data and toxiclogical analysis of anonymised samples. The data will inform of prevalence, trend data and utcome of ED patients attending with acute illict drug toxicity.

In the LASSO study, the investigators will identify 100 stimulant overdose decedents (divided among stimulant-only, and stimulant with fentanyl), conduct informant interviews (including scales and qualitative data), and gather data from the postmortem investigation (e.g., vital records, toxicology, autopsy, case narrative, death scene photographs) and medical record abstraction. Subsequently, study staff will conduct qualitative interviews with 40-60 living people who use stimulants (aiming for half methamphetamine, half cocaine) to explore elements of resilience and risk reduction strategies. This study aims to contribute to the eventual design of interventions to reduce stimulant overdose mortality.

In the setting of naloxone standing orders, this study will assess the impact of a targeted, web-based overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy. Outcomes are changes in opioid risk behaviors, naloxone uptake, and knowledge about overdose and naloxone.