Comparison of Naloxone Pharmacokinetics

Phase 1

Completed

• Conditions: Opioid-use Disorder
• Interventions: Drug: Naloxone; Device: Mucosal atomization device and syringe; Device: Narcan; Device: Intramuscular Auto Injector

• Registration Number: NCT03386591
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-29
• Study Start: 2018-01-03
• Primary Completion: 2018-02-08
• Status Verified: 2018-03
• Study Completion: 2018-03-06
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mucosal Atomization (1 administration)	Naloxone	One Intranasal administration of 2 mL naloxone using a mucosal atomization device and syringe (1 mL/nostril)
Mucosal Atomization (1 administration)	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)	Naloxone	Two Intranasal administrations of 2 mL naloxone using mucosal atomization device and syringe (1 mL/nostril) 2 minutes apart
Mucosal Atomization (2 administrations)	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	Naloxone	One Intranasal administration of 2 mg naloxone using Narcan nasal spray
Narcan 2mg	Narcan	One Intranasal administration of 2 mg naloxone using Narcan nasal spray
Narcan 4mg	Naloxone	One Intranasal administration of 4 mg naloxone using Narcan nasal spray
Narcan 4mg	Narcan	One Intranasal administration of 4 mg naloxone using Narcan nasal spray
Intramuscular auto injector	Naloxone	One Intramuscular administration of 2 mg naloxone using Evzio auto-injector
Intramuscular auto injector	Intramuscular Auto Injector	One Intramuscular administration of 2 mg naloxone using Evzio auto-injector

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of naloxone	11 days	Maximum plasma concentration, time of maximum observed concentration and area under the concentration-time curve

Secondary Outcome Measures

Name	Time	Method
Safety Assessments	16 days	Number of participants with AEs, vital signs, ECG, laboratory changes and nasal irritation following the administration of naloxone.

Trial Locations

Locations (1)

Vince and Associates Clinical Research; 🇺🇸 Overland Park, Kansas, United States