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Opioid Reversal Agent

Naloxone for Naloxone (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monthly, throughout duration of the trial

Awards & highlights

NOPACA 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.Check my eligibility

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.See study design

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.

NOPACA Trial 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.

NOPACA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Survival to hospital discharge

Secondary outcome measures

Sustained Return of Spontaneous Circulation (ROSC)

Other outcome measures

Participant retention

Proportion of OHCA eligible for study

Study Drug administration compliance

+1 more

NOPACA 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 / 3Eligibility criteria met

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Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,457 Total Patients Enrolled

Ralph Wang, MD, MASPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being enrolled in this study?

"The trial posted on clinicaltrials.gov is currently not accepting new participants. It was first listed on January 1st, 2025 and last revised on February 8th, 2024. Although this specific study is inactive in terms of patient recruitment, there are currently 88 other trials actively seeking candidates for enrollment."

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