Opioid Overdose Clinical Trial
Official title:
A Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Naloxone Following Intradermal Injection in Humans
The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics of intradermal administration of naloxone in healthy adult subjects.
Using approved drug formulations, injection devices, and assays, the investigators seek to determine the pharmacokinetics and pharmacodynamics of naloxone in human subjects using an intradermal delivery route. The long-term goal is to develop a product with better pharmacokinetic (PK) and pharmacodynamic (PD) properties than current delivery systems used in opioid overdose rescue. To the best of the investigators knowledge, this is the first study administering naloxone via an intradermal route in humans. Using an FDA-approved intranasal drug formulation, the investigators will administer 8mg/0.1ml of naloxone into the highly vascular dermal layer of the skin using microneedles in 3 healthy volunteer participants and measure plasma concentrations of naloxone for 60 minutes after injection. The investigators primary outcome measure is detectable levels of naloxone in plasma. Secondary outcome measures will be estimates of PK values derived from time versus concentration data. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04372238 -
The Rhode Island Prescription and Illicit Drug Study
|
N/A | |
| Recruiting |
NCT03924505 -
Preventing Opioid Overdose Mortality in the United States
|
N/A | |
| Completed |
NCT05093309 -
Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
|
N/A | |
| Completed |
NCT05219669 -
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
|
Phase 1 | |
| Completed |
NCT04317053 -
Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program
|
Phase 3 | |
| Recruiting |
NCT04815590 -
Extended-release Injectable Buprenorphine for Individuals at High Risk of Overdose
|
||
| Active, not recruiting |
NCT05096429 -
Preventing Overdose Using Information and Data From the Environment
|
N/A | |
| Suspended |
NCT05114460 -
Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal
|
Phase 2 | |
| Completed |
NCT02662153 -
Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics
|
||
| Active, not recruiting |
NCT05944133 -
Health Insurance Instability and Mortality Among Patients Receiving Bup Tx for OUD
|
||
| Completed |
NCT05377255 -
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
|
Phase 1 | |
| Not yet recruiting |
NCT05877118 -
Improving Availability of Intranasal Naloxone
|
N/A | |
| Recruiting |
NCT05072249 -
European Cohort Study of the Effectiveness of Take Home Naloxone
|
||
| Withdrawn |
NCT05808881 -
Clinical Outcomes From Nalmefene
|
Phase 4 | |
| Not yet recruiting |
NCT01622504 -
Naloxone Nasal Spray Pharmacokinetic Study
|
Phase 1 | |
| Completed |
NCT05506267 -
Development of a Tracheal Sound Sensor
|
||
| Completed |
NCT02535494 -
Risks and Benefits of Naloxone Prescribing
|
N/A | |
| Completed |
NCT04713709 -
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder
|
Phase 1 | |
| Active, not recruiting |
NCT05008523 -
Opioids and Police Safety Study
|
N/A | |
| Completed |
NCT05363501 -
Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers
|
Phase 1 |