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Opioid Overdose clinical trials

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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: 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: 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: 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: 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: NCT04713709 Completed - Opioid Overdose Clinical Trials

A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder

Start date: January 31, 2021
Phase: Phase 1
Study type: Interventional

A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder.

NCT ID: NCT04589676 Completed - Opioid Overdose Clinical Trials

Developing and Testing the Opioid Rapid Response System

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

This Phase I SBIR will develop and demonstrate the usability/feasibility of the Opioid Rapid Response System (OSSR) in order to reduce deaths and strain on emergency response systems from opioid overdoses.

NCT ID: NCT04530591 Completed - Clinical trials for Substance Use Disorders

User Acceptability of a Device-Based Opioid Overdose Intervention

Start date: August 25, 2020
Phase:
Study type: Observational

This pilot study evaluates the needs of opioid users for a device-based intervention for opioid overdoses. The results of this one-time short questionnaire will inform development of a novel naloxone delivery device.