Clinical trials: Drug Overdose
Fentanyl Overdose, Fentanyl Poisoning
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of…
- Trial name
- NCT07459166
- Testing
- Naloxone Hydrochloride, Fentanyl, Sterile Saline
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Clear Scientific, Inc.
Opioid Overdose
Pharmacokinetic (PK) Evaluation of Nalmefene Formulations
This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.
- Trial name
- NCT07543276
- Testing
- Nalmefene + 0.94% MgCl2, Nalmefene Hydrochloride Injection
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Knoa Pharma LLC
Vitiligo, Depressive Episode
Mental Health Associations With Vitiligo
This cohort study is a large population-based study in the UK to determine the risks of comorbid mental health conditions (including depression, anxiety and other potential psychological complications of vitiligo) in adults with…
- Conditions
- Vitiligo, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorders
- Trial name
- NCT04953338
- Testing
- Exposure of mental health condtion of interest
- Where
- United Kingdom
- Volunteers
- 36,104 people, healthy volunteers welcome
- Sponsor
- Momentum Data
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 Overdose
Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics
Retrospective study to assess incidence and predictors of opioid abuse overdose and death associated with opioid overdose among patients prescribed opioid products in long-term use.
- Trial name
- NCT02662153
- Testing
- Observation only
- Where
- 4 sites in United States
- Volunteers
- 808,455 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02866266
- Testing
- Retrospective database review
- Volunteers
- 183,452 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opioid Overdose
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
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.
- Trial name
- NCT05377255
- Testing
- 16 mg naloxone AP003, 8 mg naloxone NARCAN Nasal Spray
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Opioid Overdose
Developing and Testing the Opioid Rapid Response System
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.
- Trial name
- NCT04589676
- Testing
- Naloxone training
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Real Prevention, LLC
Acetaminophen Overdose
Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection
The primary purpose of this study is determine if a new formulation of Acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury.
- Trial name
- NCT01118663
- Testing
- Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free), Acetadote
- Where
- 14 sites in United States
- Volunteers
- 17 people
- Sponsor
- Cumberland Pharmaceuticals
Acute Myeloid Leukemia
Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia.
- Trial name
- NCT03671564
- Testing
- Milademetan
- Where
- 8 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
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
Septic Shock, Acute Respiratory Distress Syndrome
CytOSorb TreatMent Of Critically Ill PatientS Registry
Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based…
- Conditions
- Septic Shock, Acute Respiratory Distress Syndrome, Trauma, Rhabdomyolysis
- Trial name
- COSMOS (NCT05146336)
- Testing
- CytoSorb
- Where
- 28 sites in Austria, Germany and 4 more
- Volunteers
- 3,000 people
- Sponsor
- CytoSorbents, Inc
Opioid Overdose
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
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…
- Trial name
- NCT05219669
- Testing
- Nalmefene Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Opiant Pharmaceuticals Inc
Baseline Epidemiologic Assessment
Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)
The main objectives of this study are to provide surveillance/descriptive data to (a) assess utilization of MorphaBond ER and selected comparators overall and by age group and census regions using nationally-projected quarterly…
- Trial name
- BEAD-MB (NCT04033094)
- Testing
- MorphaBond ER, Comparator Drug
- Where
- United States
- Volunteers
- 17,566 people
- Sponsor
- Daiichi Sankyo
Opioid Overdose, Opioid Use Disorder
Safety, Tolerability, and Pharmacokinetics of CSX-1004
This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult…
- Trial name
- NCT06005402
- Testing
- CSX-1004
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cessation Therapeutics, Inc.
Opioid Overdose
Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers
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…
- Trial name
- NCT05363501
- Testing
- IM Naloxone Injection, Naloxone Nasal Spray, Naloxone Nasal Swab
- Where
- Canada
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pocket Naloxone Corp
Paracetamol Overdose
PP100-01 (Calmangafodipir) for Overdose of Paracetamol
Investigate the safety and tolerability of PP100-01 add-on treatment to the 12hr NAC treatment regime in patients treated for paracetamol/acetaminophen overdose (POD) when NAC treatment is initiated before 24hours post POD.
- Trial name
- POP (NCT03177395)
- Testing
- PP100-01 (calmangafodipir), Acetylcysteine
- Where
- United Kingdom
- Volunteers
- 24 people
- Sponsor
- Egetis Therapeutics AB (publ)
Opioid-Related Disorders, Opiate Addiction
Study to Validate Coded Medical Terms Used to Identify Opioid-Related Overdose in Databases Used for PMR Study 1B
The purpose of this study is to determine reliability of codes and data from electronic medical records to predict and measure overdose and death in patients prescribed opioid analgesics.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02667197
- Testing
- Algorithm to determine overdose from opioid abuse
- Volunteers
- 2,701 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Prostate Cancer
Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT
The purpose of this study is to learn if the study drug, [225Ac]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.
- Trial name
- SatisfACtion (NCT05983198)
- Testing
- 225Ac-PSMA-R2, 68Ga-PSMA-R2, 68Ga-PSMA-11
- Where
- 9 sites in United States, Australia and 2 more
- Volunteers
- 33 people
- Sponsor
- Novartis Pharmaceuticals
Toxicity Due to Chemotherapy
Uridine Triacetate as Antidote for Patients at Excess Risk of 5-FU Toxicity Due to Overdosage or Impaired Elimination
The purpose of this study is to provide emergency treatment of adult and pediatric patients: Following a fluorouracil or capecitabine overdose regardless of the presence of symptoms or Who exhibit early-onset, severe or…
- Trial name
- NCT01432301
- Testing
- uridine triacetate
- Sponsor
- Wellstat Therapeutics