Comparison of Naloxone Pharmacokinetics

National Institute on Drug Abuse (NIDA)30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opioid-use Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pharmacokinetic parameters of naloxone

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

Time frame: 11 days

Secondary Outcomes

Safety Assessments

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

Time frame: 16 days