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Completed

NCT Number: NCT03386591

Comparison of Naloxone Pharmacokinetics

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

naloxone

Drug

Comparing pharmacokinetics of naloxone

Mucosal atomization device and syringe

Device

Injection

Narcan

Device

Nasal Spray

Intramuscular Auto Injector

Device

Intramuscular injection

Other names: Evzio

Primary outcomes

  1. Pharmacokinetic parameters of naloxone

    Time frame: 11 days

    Maximum plasma concentration, time of maximum observed concentration and area under the concentration-time curve

Secondary outcomes

  1. Safety Assessments

    Time frame: 16 days

    Number of participants with AEs, vital signs, ECG, laboratory changes and nasal irritation following the administration of naloxone.

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Comparison of Naloxone Pharmacokinetics Using Marketed Naloxone Devices

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2017
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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