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Opiate Overdose clinical trials

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NCT ID: NCT05645016 Suspended - Opioid Overdose Clinical Trials

Tailoring Overdose Education for Black Churches

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Church-based interventions are culturally acceptable, reduce access barriers, and can be brought to scale in under-resourced communities. For Overdose Education and Naloxone Distribution (OEND) to be efficacious in Black churches, tailoring may be needed. For this audience, standard OEND curricula may need to be adapted to their level of knowledge of substance use disorders (SUDs), and limited general mental health literacy, and specifically address stigma related to SUDs and medications for opioid use disorder (MOUD). Finally, a tailored implementation strategy may need to address contextual variations (e.g., denomination and membership size) across churches. The proposed pilot study aims to identify the socio-cultural modifications that will be needed to adapt our previously developed training (i.e., COEST) to target Black communities of faith. In a pilot randomized controlled trial (RTC) of adapted COEST in a stepped-wedge design.

NCT ID: NCT05506267 Completed - Clinical trials for Respiratory Insufficiency

Development of a Tracheal Sound Sensor

Start date: June 1, 2020
Phase:
Study type: Observational

An observational study will be conducted in 20 hospitalized surgical patients routinely managed with opioids for anesthesia and post-operative pain control. Trachea Sound Sensor measurements and reference respiratory measurements will be recorded and analyzed to develop diagnostic algorithms that produce a risk-index score that detects/predicts progression from mild hypoventilation, to moderate hypoventilation, to severe hypoventilation due to opioids and other medications that cause respiratory depression. Our current Trachea Sound Sensor (TSS) has a wired Sony commercial microphone integrated into a commercial pediatric stethoscope, coupled to the skin surface over the trachea at the sternal notch. The Trachea Sound Sensor will measure and record the sounds of air moving within the proximal trachea during inhalation and exhalation. The microphone signal will be converted into an accurate measurement of the patient's respiratory rate and tidal volume (during inhalation & exhalation) over time, to determine the minute ventilation trend, breathing patterns, apnea episodes, and degree of snoring (due to partial upper airway obstruction). A commercial respiratory facemask and two pneumotachs (gas flow sensors) will also be used to accurately and continuously measure the patient's respiratory rate and tidal volume (during inhalation & exhalation) to determine the minute ventilation trend, breathing patterns, and apnea episodes. TSS data and reference respiratory data will be collected prior to surgery with the patient breathing normally (baseline), in the Operating Room (OR) during the induction and maintenance of anesthesia, in the Post Anesthesia Care Unit (PACU), and on the general nursing floors of Thomas Jefferson University Hospital (TJUH). The sounds of air flowing through the proximal trachea will be correlated with the reference breathing measurements using signal processing methods to optimize the measurement accuracy of RR, TV, breathing pattern, apnea episodes, and degree of snoring. A commercial accelerometer may be coupled to the skin surface of the neck (with tape) to measure body position and activity level. The TSS and vital sign trend data will be analyzed to produce a Risk-Index Score every 30 seconds with alerts and alarms that warn the patient and caregivers about progressive Opioid Induced Respiratory Depression (OIRD).

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: NCT05377255 Completed - Opioid Overdose Clinical Trials

Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults

Start date: March 28, 2022
Phase: Phase 1
Study type: Interventional

This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.

NCT ID: NCT05363501 Completed - Opioid Overdose Clinical Trials

Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers

Start date: January 21, 2021
Phase: Phase 1
Study type: Interventional

The study consists of two Phases with the first phase (Pilot Phase) divided into two sub phases. In each study phase, subjects will be admitted to the clinical unit from 10 hours prior to the first drug administration on Day -1 until approximately 12 hours following the last study drug administration. Screening of alcohol and drugs of abuse will be performed before the first study drug administration. For female subjects, a pregnancy test will be performed before the first drug administration. Clinical nasal irritation rating and the Brief Smell Identification Test will be performed at screening.

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: 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.