Opioid Overdose Clinical Trial
Official title:
A Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Naloxone Following Intradermal Injection in Humans
The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics of intradermal administration of naloxone in healthy adult subjects.
Status | Not yet recruiting |
Enrollment | 3 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Ability to participate in the informed consent process - Good peripheral venous access for proposed pharmacokinetic sampling - Has not taken an investigational drug within prior 30 days (or 5 half-lives, whichever is longer) Exclusion Criteria: - Allergy to Naloxone or vehicle constituents (namely parabens) - Active substance use as defined by a positive screen for drugs of abuse within seven days of study participation - History of substance use disorder - Taking opiate/opioid medications for any indication - Chronic pain disorder - Pregnant or breastfeeding - Adults lacking capacity to consent, non-English speaking persons, or prisoners. - Other medical history or active conditions deemed not safe for participation by the investigator - Hematocrit <35% |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | DEKA S.r.l. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | up to 60 minutes | |
Secondary | 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. | up to 60 minutes | |
Secondary | 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. | up to 60 minutes | |
Secondary | 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. | up to 60 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04372238 -
The Rhode Island Prescription and Illicit Drug Study
|
N/A | |
Recruiting |
NCT03924505 -
Preventing Opioid Overdose Mortality in the United States
|
N/A | |
Completed |
NCT05093309 -
Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
|
N/A | |
Completed |
NCT05219669 -
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
|
Phase 1 | |
Completed |
NCT04317053 -
Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program
|
Phase 3 | |
Not yet recruiting |
NCT06466005 -
UnityPhilly Response App for Overdose Reversal
|
||
Recruiting |
NCT04815590 -
Extended-release Injectable Buprenorphine for Individuals at High Risk of Overdose
|
||
Active, not recruiting |
NCT05096429 -
Preventing Overdose Using Information and Data From the Environment
|
N/A | |
Suspended |
NCT05114460 -
Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal
|
Phase 2 | |
Recruiting |
NCT06238128 -
Opioid Rapid Response System: Naloxone Training in Communities
|
N/A | |
Completed |
NCT02662153 -
Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics
|
||
Active, not recruiting |
NCT05944133 -
Health Insurance Instability and Mortality Among Patients Receiving Bup Tx for OUD
|
||
Completed |
NCT05377255 -
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
|
Phase 1 | |
Recruiting |
NCT05877118 -
Improving Availability of Intranasal Naloxone
|
N/A | |
Recruiting |
NCT05072249 -
European Cohort Study of the Effectiveness of Take Home Naloxone
|
||
Withdrawn |
NCT05808881 -
Clinical Outcomes From Nalmefene
|
Phase 4 | |
Not yet recruiting |
NCT01622504 -
Naloxone Nasal Spray Pharmacokinetic Study
|
Phase 1 | |
Not yet recruiting |
NCT06429436 -
Vending Machine Naloxone Distribution for Your Community (VENDY)
|
Phase 4 | |
Completed |
NCT05506267 -
Development of a Tracheal Sound Sensor
|
||
Completed |
NCT02535494 -
Risks and Benefits of Naloxone Prescribing
|
N/A |