Comparison of Naloxone Pharmacokinetics Using Marketed Naloxone Devices
| Registry | NCT03386591 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 30 (Actual) |
| Sponsor | National Institute on Drug Abuse (NIDA) (Nih) |
| Conditions | Opioid-use Disorder |
| Interventions | Naloxone, Mucosal atomization device and syringe, Narcan, Intramuscular Auto Injector (Drug, device) |
| Dates | start 2018-01-03, primary completion 2018-02-08, completion 2018-03-06, first posted 2017-12-29, last updated 2018-03-09 |
| Locations | 1 site in United States |
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All trials for Opioid-use Disorder All trials of Naloxone All trials of Mucosal atomization device and syringe
Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Mucosal Atomization (1 administration) | Experimental | Drug: Naloxone; Device: Mucosal atomization device and syringe | One Intranasal administration of 2 mL naloxone using a mucosal atomization device and syringe (1 mL/nostril) |
| Mucosal Atomization (2 administrations) | Experimental | Drug: Naloxone; Device: Mucosal atomization device and syringe | Two Intranasal administrations of 2 mL naloxone using mucosal atomization device and syringe (1 mL/nostril) 2 minutes apart |
| Narcan 2mg | Experimental | Drug: Naloxone; Device: Narcan | One Intranasal administration of 2 mg naloxone using Narcan nasal spray |
| Narcan 4mg | Experimental | Drug: Naloxone; Device: Narcan | One Intranasal administration of 4 mg naloxone using Narcan nasal spray |
| Intramuscular auto injector | Experimental | Drug: Naloxone; Device: Intramuscular Auto Injector | One Intramuscular administration of 2 mg naloxone using Evzio auto-injector |
Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers
Inclusion Criteria: * Males and females 18 to 55 years of age, inclusive * Provide written informed consent * BMI ranging from 18 to 32 kg/m2, inclusive * Adequate venous access * No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG * Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm from the screening visit until 90 days after the last study drug administration * Female subjects of childbearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after the last study drug administration. Oral contraceptives are prohibited * Agree not to ingest alcohol, drinks containing xanthine >500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study Exclusion Criteria: * Contact site directly for more information
| Facility | City | Country | Status |
|---|---|---|---|
| Vince and Associates Clinical Research | Overland Park, Kansas | United States |