Clinical trials: Overdose
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
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.
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
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-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)
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
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
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 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
Healthy Adult, Overdose Antidote
Safety and Pharmacokinetics of Rescue Liposome in Healthy Adults
This is a Phase 1 study to assess the safety and tolerability of the liposomal product in healthy participants.
- Trial name
- NCT07375498
- Testing
- liposome dispersion
- Where
- Brazil
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
Opioid Use Disorder, Opioid Withdrawal
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
IBO-CARE is a single-site Phase 1/2a study evaluating the safety, tolerability, feasibility and preliminary outcomes of medically supervised ibogaine with 12 months of recovery support in adults with moderate-to-severe opioid use…
- Conditions
- Opioid Use Disorder, Opioid Withdrawal, Substance Use Disorders
- Trial name
- IBO-CARE (NCT07871877)
- Testing
- Ibogaine Hydrochloride, Extended-release naltrexone injection, 380 mg, My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Clive Michelsen
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)
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
Blood Glucose, High, Oral Hypoglycaemic Overdose
Impact of Oral Glucose Tolerance Test on Extent of Hemoglobin Glycation
The glycation extent of human hemoglobin is under control of the Maillard reaction, a chemical interaction between an amino acide and a reducing sugar.
- Trial name
- HbA1c (NCT04018430)
- Where
- Switzerland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Urs E. Nydegger
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
Methamphetamine Intoxication (Disorder)
Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose
The hypothesis of this multisite Phase 2a study is that IXT-m200 will be well-tolerated in patients with acute mild to moderate METH toxicity.
- Trial name
- Meth-OD (NCT04715230)
- Testing
- IXT-m200, Lorazepam, Haloperidol
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- InterveXion Therapeutics, 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, 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.
Pharmacokinetics, Healthy Volunteer
Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
A single dose dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release(ER) capsule prototypes.
- Trial name
- NCT06500793
- Testing
- PF614 capsule, Nafamostat Mesylate
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Ensysce Biosciences
Hepatitis
To Evaluate the Efficacy and Safety of TYNADOTE® in the Treatment of Acetaminophen Overdose
To evaluate the efficacy and safety of TYNADOTE® in the treatment of acetaminophen overdose
- Trial name
- NCT05557448
- Testing
- TYNADOTE
- Where
- Taiwan
- Volunteers
- 24 people
- Sponsor
- Sinew Pharma Inc.