Comparison of Naloxone Pharmacokinetics

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Opioid-use Disorder

Treatments: Device: Narcan; Device: Intramuscular Auto Injector; Drug: Naloxone; Device: Mucosal atomization device and syringe

Study type: Interventional

Funder types: NIH

Identifiers

NCT03386591

Naloxone P1a-003

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Mucosal Atomization (1 administration)

Experimental group

Description:

One Intranasal administration of 2 mL naloxone using a mucosal atomization device and syringe (1 mL/nostril)

Treatment:

Device: Mucosal atomization device and syringe

Drug: Naloxone

Mucosal Atomization (2 administrations)

Experimental group

Description:

Two Intranasal administrations of 2 mL naloxone using mucosal atomization device and syringe (1 mL/nostril) 2 minutes apart

Treatment:

Device: Mucosal atomization device and syringe

Drug: Naloxone

Narcan 2mg

Experimental group

Description:

One Intranasal administration of 2 mg naloxone using Narcan nasal spray

Treatment:

Device: Narcan

Drug: Naloxone

Narcan 4mg

Experimental group

Description:

One Intranasal administration of 4 mg naloxone using Narcan nasal spray

Treatment:

Device: Narcan

Drug: Naloxone

Intramuscular auto injector

Experimental group

Description:

One Intramuscular administration of 2 mg naloxone using Evzio auto-injector

Treatment:

Device: Intramuscular Auto Injector

Drug: Naloxone