Naloxone for Opioid Associated Out of Hospital Cardiac Arrest

NCT06251609 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NOPACAV1
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator's long-term goal is to conduct Naloxone for Opioid Associated out of Hospital Cardiac Arrest (NOPACA), a randomized, double blind, controlled trial to determine the efficacy of naloxone vs. placebo in Opioid Associated out of Hospital Cardiac Arrest. The investigative team plan to randomize patients in OHCA to early naloxone administration vs. placebo after initial resuscitation and measure ROSC and survival. Challenges to designing NOPACA include uncertainty regarding: 1) the available pool of participants and number of EMS agencies needed to meet enrollment targets; 2) acceptability among patients, EMS and Emergency Medicine provider stakeholders, and 3) estimates of the study outcomes needed for sample size estimates. Toward obtaining the necessary information to design NOPACA, the investigators propose a pilot RCT of participants at high risk for OA-OHCA to verify a reasonable recruitment rate; treatment fidelity and acceptability; and adequate retention and measurement of outcomes at follow up. The investigators propose incorporating hypothesis testing of the feasibility outcomes to determine progression to a definitive trial.

Conditions

Heart Arrest, Out-Of-Hospital; Opioid Overdose; Naloxone

Outcome Measures

Primary Outcomes (1)

• Survival to hospital discharge

  Survival to hospital discharge is defined as patient is discharged from the hospital acute care unit alive regardless of neurological status, outcome or destination.

  Through hospital discharge, an average of up to 5 days

Secondary Outcomes (1)

• Sustained Return of Spontaneous Circulation (ROSC)

  Through completion of the index EMS encounter, an average of 30 minutes

Other Outcomes (4)

• Sufficient subjects to conduct the trial

  Monthly, throughout duration of the trial

• Proportion of OHCA eligible for study

  Monthly, throughout duration of the trial

• Study Drug administration compliance

  Between time of randomization and end of EMS encounter, an average of 30 minutes

Study Arms (2)

Naloxone

ACTIVE COMPARATOR

The intervention consists of naloxone 2mg (2ml of 1mg/ml solution) administered by EMS personnel via the IV or IO route. The study intervention will be administered immediately (within 5 minutes) following the first dose of epinephrine.

Drug: Naloxone 2 MG

Saline

PLACEBO COMPARATOR

Saline 2ml will be supplied in pre-filled syringes within numbered trial treatment packs. The trial will be double-blind; patients, investigators, and the clinical team will be blinded. Only the pharmacy providing the numbered syringes will be aware of the allocation but will not be involved with clinical care or outcome evaluation. The saline placebo will be stored in syringes identical to the naloxone syringes without identifying features.

Drug: Saline 2ml

Interventions

Naloxone 2 MG DRUG

The intervention consists of naloxone 2mg (2ml of 1mg/ml solution) administered by EMS personnel via the IV or IO route. The study intervention will be administered immediately (within 5 minutes) following the first dose of epinephrine. When naloxone hydrochloride is administered intravenously, the onset of action is generally apparent within two minutes. The naloxone will be administered following the first dose of epinephrine. The control is saline 2ml will be supplied in pre-filled syringes within numbered trial treatment packs. They will be identical in appearance to the naloxone syringes.

Also known as: narcan

Naloxone

Saline 2ml DRUG

Placebo

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible if all the following criteria are met:
• Adults (age ≥ 18 years) in OHCA per EMS protocol. ACLS interventions have been initiated by EMS: chest compressions, ventilation; • 1st dose of epinephrine given via IV or IO.
• . At risk of OA-OHCA (EMS presumed drug-related OHCA or NACARDI positive for occult OA-OHCA) as described above.

You may not qualify if:

• EMS plans to administer naloxone, or administration of naloxone by EMS during the same encounter
• Cardiac arrest apparently caused by trauma, choking, or drowning.
• Known or apparent pregnancy
• Patient experiences ROSC prior to study drug administration

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94122, United States

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Opiate Overdose

Interventions

Naloxone; Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ralph Wang, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralph C. Wang, MD, MAS

CONTACT

(510) 384-9514; ralph.wang@ucsf.edu

Elizabeth Butrick, MS

CONTACT

(415) 601-6399; elizabeth.butrick@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 9, 2024
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

US (1)