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Opiate Overdose clinical trials

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NCT ID: NCT05219669 Completed - Opioid Overdose Clinical Trials

Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens

Start date: September 1, 2021
Phase: Phase 1
Study type: Interventional

This study is to compare the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given as a single dose intranasally (IN;into the nose), as a single dose in each nostril and as two doses in one nostrils; and to evaluate the safety and tolerability of nalmefene IN.

NCT ID: NCT05123027 Completed - Opioid Overdose Clinical Trials

Peer Intervention to Link Overdose Survivors to Treatment (PILOT)

PILOT
Start date: December 28, 2021
Phase: N/A
Study type: Interventional

The purpose of the Peer Intervention to Link Overdose Survivors to Treatment (PILOT) study is to improve outcomes for individuals after surviving an overdose involving opioids. This study will be comparing the enhanced peer intervention known as PILOT for overdose survivors with treatment as usual (TAU) provided in the Emergency Department.

NCT ID: NCT05116852 Active, not recruiting - Opioid Use Disorder Clinical Trials

Community and Familial Impacts of the Opioid Crisis

Start date: April 1, 2022
Phase:
Study type: Observational

This study aims to analyze the needs of those who have lost a loved one to opioid-related death and/or those currently supporting a loved one in treatment for Opioid Use Disorder. Mental health status related to the death or support of a loved one will be assessed through a survey and through the use of several modules of the CAT-MH (computerized adaptive testing-mental health suite) questionnaire.

NCT ID: NCT05114460 Suspended - Opioid Overdose Clinical Trials

Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal

Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

The goal of the proposed, proof-of-concept study is to test the combined effects of vaporized marijuana [Delta-9-tetrahydracannabinol (THC)] with NLX as a proof of concept towards the possible development of a combined overdose reversal agent with improved tolerability.

NCT ID: NCT05096429 Active, not recruiting - Opioid Overdose Clinical Trials

Preventing Overdose Using Information and Data From the Environment

PROVIDENT
Start date: November 15, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05093309 Completed - Opioid Overdose Clinical Trials

Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

Start date: September 18, 2018
Phase: N/A
Study type: Interventional

Objectives: The purpose of this study was to assess the impact of the Empowering Community Pharmacists program on pharmacists' knowledge, perceived barriers, attitudes, confidence, and intentions regarding naloxone services implementation, as well as change in number of naloxone prescriptions dispensed. Methods: A 3-month pragmatic randomized controlled trial was conducted in 2018-2019. Alabama community pharmacists were recruited by email, phone, fax, and mailed postcards and randomized to intervention (monthly resources/reminders + educational webinar) or control (monthly resources/reminders + delayed educational webinar). Outcome measures were assessed via online surveys at baseline (T1), immediately post-intervention (T2), and 3-months post-intervention (T3), including: naloxone knowledge (percent correct); perceived barriers, attitudes, and confidence regarding naloxone services implementation (7-point Likert-type scale, 1=strongly disagree to 7=strongly agree); and number of naloxone prescriptions dispensed. Mean differences between control and intervention groups from T1-T3 were assessed using two-way mixed ANOVA and adjusted analyses were conducted using generalized estimating equations (GEE) with negative binomial distribution (alpha=0.05).

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: NCT05008523 Active, not recruiting - Opioid Overdose Clinical Trials

Opioids and Police Safety Study

OPS
Start date: January 22, 2021
Phase: N/A
Study type: Interventional

Overdose deaths are currently the largest cause of accidental death in the US and opioid-related overdose deaths constitute the overwhelming majority of these deaths. Demands for a knowledge-base for effective law enforcement interventions is growing. This proposed study is designed to provide a knowledge base regarding key obstacles and facilitators of the willingness and preparedness of police to administer naloxone and related risk reduction practices and evaluate the efficacy of a web-based opioid-related occupational safety and risk reduction curriculum. Findings from this study will be applied to the development and implementation of effective interventions for police officers aimed at harmonizing law enforcement practices with public health goals.

NCT ID: NCT04984109 Completed - Pain, Postoperative Clinical Trials

Ultrasound-guided PENG Block in Total Hip Replacement

Start date: August 2, 2021
Phase: N/A
Study type: Interventional

- This randomized controlled study will be carried out on 60 adult patients undergoing primary total hip replacement in Tanta University Hospitals. All Patients will receive spinal anesthesia with either sham or real US-guided PENG block. - The primary outcome will be the time to first request for rescue analgesia. The secondary outcome will be the postoperative Numeric Rating Scale (NRS) score and the total morphine consumption (rescue analgesia) in the first 24 h postoperatively.

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).