Clinical trials: Opioid-Induced Respiratory Depression
Opioid Overdose
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into…
- Trial name
- NCT06719986
- Testing
- Nalmefene HCl injection, Naloxone HCl intranasal
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Opioid; Intoxication, Perception Disturbance (Acute), Acute Pain
Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression
Volunteers will receive a weight-based opioid (remifentanil) infusion for 10 minutes. In the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at baseline, and at 2.5-minute intervals…
- Conditions
- Opioid; Intoxication, Perception Disturbance (Acute), Acute Pain, Overdose of Opiate, Respiratory Depression
- Trial name
- NCT04301895
- Testing
- Continuous conversational interaction, Remifentanil infusion
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Respiratory Depression
Precision Medicine in Anesthesia
This study is designed to look at how often a decrease in the rate of breathing occurs after being given a routinely used intravenous (IV) pain medication.
- Trial name
- NCT04495452
- Testing
- Fentanyl Drug Administration
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Opioid-Induced Respiratory Depression, Postoperative Complications (Cardiopulmonary)
Pupillometry in Identifying Risk of Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy
This study will evaluate whether quantitative pupillometry measurements can be used to identify children at risk for postoperative opioid-induced respiratory depression (OIRD) following tonsillectomy.
- Conditions
- Opioid-Induced Respiratory Depression, Postoperative Complications (Cardiopulmonary), Respiratory Complications Due to Anesthesia
- Trial name
- NCT07573150
- Testing
- Infrared Pupillometry
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- NeurOptics Inc
Drug Overdose, Opioid-Related Disorders
Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose
RTM Vital Signs, LLC is developing a miniature wearable tracheal sound sensor that communicates with a cell phone containing a machine-learning diagnostic algorithm designed to detect and predict the onset of mild, moderate, and…
- Trial name
- NCT03845699
- Testing
- Diagnostic algorithms that detects/predicts hypoventilation
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- RTM Vital Signs, LLC
Opioid Induced Respiratory Depression, Chronic Opioid Use
Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists
n this pharmacokinetic/pharmacodynamic modelling study we will determine the ability of intranasal and intravenous naloxone and intravenous nalmefene to reverse opioid (fentanyl and sufentanil)- induced respiratory depression in…
- Trial name
- ROAR (NCT05338632)
- Testing
- Narcan 40 MG/ML Nasal Spray, Naloxone Hydrochloride, Nalmefene HCl injection
- Where
- Netherlands
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Opioid-induced Respiratory Depression
Combined Effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on Breathing
Opioids are commonly prescribed for moderate to severe pain. While initially intended for moderate to severe acute and cancer pain, opioids are currently frequently considered and prescribed in chronic noncancer pain.
- Trial name
- POLO (NCT05598905)
- Testing
- Pregabalin 150mg, Oxycodone 10mg, Lacosamide 150 mg
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Opiate Induced Respiratory Depression
Antagonism of Opioid-Induced Respiratory Depression by CX1739 With Preservation of Opioid Analgesia
The study is an investigation to assess the capacity of ascending doses of CX1739 to antagonize the respiratory depressive effect of remifentanil.
- Trial name
- NCT02735629
- Testing
- CX1739 - 300 mg, CX1739 - 600 mg, CX1739 - 900 mg
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- RespireRx
Respiratory Depression
Predictors of Opioid-Induced Respiratory Depression (OIRD)
Purpose of the Study: (1) To classify an individual subject's ventilatory response in terms of respiratory depression to a bolus of remifentanil under normoxic and hyperoxic conditions.
- Trial name
- (OIRD) (NCT02473354)
- Testing
- Remifentanil, Oxygen, Carbon dioxide
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Duke University
Chronic Pain, Chronic Pain Syndrome
Outcomes Mandate National Integration With Cannabis as Medicine
This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.
- Conditions
- Chronic Pain, Chronic Pain Syndrome, Chronic Pain Due to Injury, Chronic Pain Due to Trauma
- Trial name
- OMNI-Can (NCT03944447)
- Testing
- Cannabis, Medical, RYAH-Medtech Inhaler
- Where
- 17 sites in United States
- Volunteers
- 200,000 people, healthy volunteers welcome
- Sponsor
- OMNI Medical Services, LLC
Opioids, Obstructive Sleep Apnea (OSA)
Impacts of Opioids on Respiratory Drive During Sleep
The investigators are studying the impact that opioids have on breathing during sleep in healthy participants and those diagnosed with obstructive sleep apnea.
- Trial name
- OIRD (NCT06854211)
- Testing
- Morphine p.o.
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Respiratory Depression, Cannabis Use
Influence of Δ9-tetrahydrocannabinol (THC) on Oxycodone Induced Ventilatory Depression in Healthy Volunteers
Rationale: Opioid misuse and abuse are common problems in the Western world. The rate of unintentional drug overdose is rapidly increasing, not only in the Unites States but also in the Netherlands.
- Conditions
- Respiratory Depression, Cannabis Use, Opioid Use
- Trial name
- COXY (NCT05235503)
- Testing
- Medicinal cannabis in combination with oxycodon
- Where
- Netherlands
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Respiratory Complications, Opioid Induced Respiratory Depression
Timing of Opioid Administration and Postoperative Respiratory Depression.
The goal of this study is to determine if a relationship can be detected between the administration of an opioid and quantitative respiratory depression in spontaneously breathing non-intubated patients who have undergone general…
- Conditions
- Respiratory Complications, Opioid Induced Respiratory Depression, Postoperative Respiratory Complications
- Trial name
- NCT07227389
- Testing
- Respiratory volume monitoring
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Wayne State University
Respiratory Depression
ENA-001 for Opioid Induced Respiratory Depression
This study is a Phase I clinical trial to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profiles with single intravenous (IV) and intramuscular (IM) doses of ENA-001.
- Trial name
- NCT06967259
- Testing
- ENA-001
- Where
- 2 sites in United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Enalare Therapeutics Inc.
Respiratory Insufficiency, Clinical Deterioration
Wearable Wireless Respiratory Monitoring System That Detects and Predicts Opioid Induced Respiratory Depression
An observational study will be conducted in approximately 14 participants to evaluate the ability of a wearable, wireless acoustic Respiratory Monitoring System (RMS) to accurately measure a participant's respiratory rate, tidal…
- Trial name
- NCT06442488
- Testing
- Respiratory Monitoring System
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Jeffrey Joseph
Respiratory Depression
Precision Medicine in Anesthesia: Genetic Component in Opioid-induced Respiratory Depression
The concept of precision medicine - taking individual variability into account when planning preventions and interventions - is not new but is quickly gaining attention in this age of powerful methodology of patient…
- Trial name
- NCT03441282
- Testing
- Fentanyl
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham