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Opioid Reversal Agent

Naloxone for Opioid Overdose and Cardiac Arrest (NOPACA Trial)

Phase 2

Waitlist Available

Led By Ralph Wang, MD, MAS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults in OHCA with advanced life support initiated by EMS provider

CPR and ventilation initiated; 1st dose of epinephrine given IV/IO

Must not have

EMS plans to administer naloxone, or administration of naloxone by EMS during the same encounter

Cardiac arrest apparently caused by trauma, choking, or drowning

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monthly, throughout duration of the trial

Summary

This trial aims to study the effectiveness of naloxone compared to a placebo in treating out-of-hospital cardiac arrest cases related to opioid use. The researchers plan to randomly assign patients to receive either nal

Who is the study for?

This trial is for individuals who have experienced an out-of-hospital cardiac arrest suspected to be due to opioid overdose. Specific details about eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

What is being tested?

The NOPACA trial is testing whether naloxone (a medication that can reverse the effects of opioids) is more effective than a placebo (saline solution) in improving outcomes after cardiac arrest outside of hospital settings. Participants will be randomly assigned to receive either naloxone or placebo.

What are the potential side effects?

Naloxone may cause side effects such as withdrawal symptoms in people dependent on opioids, including agitation, rapid heart rate, and sweating. However, specific side effects related to this trial are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I received advanced life support from EMS for an out-of-hospital cardiac arrest.

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I've received CPR, ventilation, and an initial dose of epinephrine.

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I am under 50 and had a sudden, unexpected collapse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I will receive or have received naloxone from emergency services.

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My cardiac arrest was due to an injury, choking, or drowning.

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I had a return of spontaneous circulation before getting the study drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monthly, throughout duration of the trial

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monthly, throughout duration of the trial

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly, throughout duration of the trial for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Survival to hospital discharge

Secondary study objectives

Sustained Return of Spontaneous Circulation (ROSC)

Other study objectives

Participant retention

Proportion of OHCA eligible for study

Study Drug administration compliance

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: NaloxoneActive Control1 Intervention

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.

Group II: SalinePlacebo Group1 Intervention

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.

0 / 6Eligibility criteria met