Opioid-use Disorder
Conditions
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.
Interventions
DRUGNaloxone
Comparing pharmacokinetics of naloxone
DEVICEMucosal atomization device and syringe
Injection
DEVICENarcan
Nasal Spray
DEVICEIntramuscular Auto Injector
Intramuscular injection
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This will be an inpatient open-label, randomized, 5-period, 5-treatment, 5-sequence, crossover study involving approximately 30 healthy subjects.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters of naloxone | 11 days | Maximum plasma concentration, time of maximum observed concentration and area under the concentration-time curve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessments | 16 days | Number of participants with AEs, vital signs, ECG, laboratory changes and nasal irritation following the administration of naloxone. |
Countries
United States
Outcome results
None listed