Comparison of Naloxone Pharmacokinetics

NCT ID: NCT03386591

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2018-03-06

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.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mucosal Atomization (1 administration)

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

Group Type: EXPERIMENTAL

Naloxone

Intervention Type: DRUG

Comparing pharmacokinetics of naloxone

Mucosal atomization device and syringe

Intervention Type: DEVICE

Injection

Mucosal Atomization (2 administrations)

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

Group Type: EXPERIMENTAL

Naloxone

Intervention Type: DRUG

Comparing pharmacokinetics of naloxone

Mucosal atomization device and syringe

Intervention Type: DEVICE

Injection

Narcan 2mg

One Intranasal administration of 2 mg naloxone using Narcan nasal spray

Group Type: EXPERIMENTAL

Naloxone

Intervention Type: DRUG

Comparing pharmacokinetics of naloxone

Narcan

Intervention Type: DEVICE

Nasal Spray

Narcan 4mg

One Intranasal administration of 4 mg naloxone using Narcan nasal spray

Group Type: EXPERIMENTAL

Naloxone

Intervention Type: DRUG

Comparing pharmacokinetics of naloxone

Narcan

Intervention Type: DEVICE

Nasal Spray

Intramuscular auto injector

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

Group Type: EXPERIMENTAL

Naloxone

Intervention Type: DRUG

Comparing pharmacokinetics of naloxone

Intramuscular Auto Injector

Intervention Type: DEVICE

Intramuscular injection

Interventions

Naloxone

Comparing pharmacokinetics of naloxone

Intervention Type: DRUG

Mucosal atomization device and syringe

Injection

Intervention Type: DEVICE

Narcan

Nasal Spray

Intervention Type: DEVICE

Intramuscular Auto Injector

Intramuscular injection

Intervention Type: DEVICE

Other Intervention Names

Evzio

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra Kelsh, MD

Role: PRINCIPAL_INVESTIGATOR

Vince and Associates Clinical Research

Locations

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

Naloxone P1a-003

Identifier Type: -

Identifier Source: org_study_id