A Phase 4 interventional study of intradermal naloxone and microneedle injection in Opioid Overdose, sponsored by Johns Hopkins University. Withdrawn. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Johns Hopkins University · Phase 4, Interventional, and Other
The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics of intradermal administration of naloxone in healthy adult subjects.
Using approved drug formulations, injection devices, and assays, the investigators seek to determine the pharmacokinetics and pharmacodynamics of naloxone in human subjects using an intradermal delivery route. The long-term goal is to develop a product with better pharmacokinetic (PK) and pharmacodynamic (PD) properties than current delivery systems used in opioid overdose rescue. To the best of the investigators knowledge, this is the first study administering naloxone via an intradermal route in humans. Using an FDA-approved intranasal drug formulation, the investigators will administer 8mg/0.1ml of naloxone into the highly vascular dermal layer of the skin using microneedles in 3 healthy volunteer participants and measure plasma concentrations of naloxone for 60 minutes after injection. The investigators primary outcome measure is detectable levels of naloxone in plasma. Secondary outcome measures will be estimates of PK values derived from time versus concentration data.
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
Browse Opiate Overdose studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: intradermal naloxone · Device: microneedle injection
One time 8 mg/0.1 mL dose of naloxone to be administered intradermally
Intradermal delivery of naloxone using microneedle
Detection of Plasma Naloxone Concentration (ng/mL) using High Performance Liquid Chromatography/Tandem Mass Spectrometry (HPLC-MS/MS).
Plasma Naloxone concentration (ng/mL) will be measured using HPLC-MS/MS at multiple timepoints following an intradermal injection of 8mg dose of Naloxone. The primary outcome is the presence or absence of detectable Naloxone at any time point. Time points include T0 (pre-Naloxone), 1, 2, 4, 6, 8, 12.5, 15, 30, 45, and 60 minutes after Naloxone treatment. Multiples of time points between participants will be taken as a simple mean average for that specific time point, and any samples below the limit of assay detection will be excluded from calculation.
Time frame: up to 60 minutes
Measurement of the maximum plasma concentration (Cmax; ng/mL) of Naloxone using HPLC-MS/MS following a single 8mg dose of intradermally delivered Naloxone.
Using the data collected for the primary outcome, a secondary analysis will be done to determine the maximum concentration of Naloxone (Cmax) reached in plasma during the course of 60 minutes after an intradermal injection of Naloxone. Cmax will be taken as the highest mean average concentration (ng/ml) of plasma naloxone achieved at any given time point (times listed under primary outcomes). In conjunction with other data from this study, absorption rate and other important pharmacologic measures can be estimated to guide development of future phase 1 pharmacokinetic trials.
Time frame: up to 60 minutes
Assessment of the time (minutes) at which the maximum Naloxone concentration (ng/mL) is detected in plasma (Tmax) by HPLC-MS/MS after a single 8mg dose of intradermally delivered Naloxone.
Using the data collected for the primary outcome, another secondary analysis will be done to determine the time at which Naloxone concentration reaches a maximum during the course of 60 minutes after an intradermal injection of Naloxone. This will be determined by selecting the time point at which the highest mean average concentration (ng/ml) of plasma Naloxone is achieved among any of the times point listed under primary outcomes. In conjunction with other data from this study, absorption rate and other important pharmacologic measures can be estimated to guide development of future phase 1 pharmacokinetic trials.
Time frame: up to 60 minutes
Assessment of Naloxone exposure (mg*h/L) over 60 minutes (AUC 0-60) as measured by HPLC-MS/MS of plasma samples collected after a single 8mg dose of intradermally delivered Naloxone.
Additionally, Naloxone concentrations (ng/mL) taken from the above experiment will be averaged (mean) for each time point and then used to calculate the Area Under the Curve (AUC; mg\*h/L) as a measure of Naloxone exposure over the course of 60 minutes after intradermal Naloxone injection. In conjunction with other data from this study, absorption rate and other important pharmacologic measures can be estimated to guide development of future phase 1 pharmacokinetic trials.
Time frame: up to 60 minutes
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2024; primary completion for Dec 2024, 4 months later.
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This study is withdrawn, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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