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Not yet recruitingNCT07806565naloxone-IHCAUpdated Sep 8, 2026

Naloxone for In-Hospital Cardiac Arrest

A Phase 2/3 interventional study of naloxone and Placebo in Heart Arrest, sponsored by Region Skane. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Region Skane · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
850
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to learn if the drug naloxone in addition to cardiopulmonary resuscitation improves outcomes of in-hospital cardiac arrets. The main questions it aims to answer are:

Does naloxone improve survival after the cardiac arrest? Does naloxone improve functional outcome in survivors of cardiac arrest? Does naloxone improve health related quality of life after the cardiac arrest? How common are adverse reactions to naloxone when administered during cardiopulmonary resuscitation.

Researchers will compare naloxone to a placebo (a look-alike substance that contains no drug) to see if naloxone works during cardiac arrest.

02

Conditions studied

  • Heart Arrest

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Keywords

  • naloxone
  • in-hospital cardiac arrest
03

In context

Heart Arrest

926 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.

This study's planned enrollment of 850 is above the median of 100 across 518 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. In-Hospital Cardiac Arrest
  2. Age ≥ 18 years
  3. Received at least one dose of adrenaline during CPR

Exclusion criteria

Exclusion Criteria:

  1. "Do-not-resuscitate"-order
  2. Known/suspected pregnancy
  3. Known objection by the patient to participate in the trial
  4. Previous inclusion in the trial
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
850 participants (estimated)

Study arms

  • Active comparator
    naloxone

    Drug: naloxone

  • Placebo comparator
    placebo

    Drug: Placebo

Interventions

  • 2 mg naloxone administered intravenously or intraosseously

  • DrugPlacebo

    0.9% saline administered intravenously or intraosseously

06

What researchers measure

Primary outcomes

  1. 30-day survival

    proportion of patients alive

    Time frame: 30 days after the cardiac arrest

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — After the publication of the last results, all de-identified individual patient data will be made available for data sharing. Data will be available for any research with ethical approval and with methodology approved by the steering committee of the current trial. Authorship of publications emerging from the shared data will follow standard authorship guidelines

Supporting information: Study protocol, Statistical analysis plan

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07806565
Lead sponsor
Region Skane
Collaborators
Lund University, Clinical Studies Sweden - Forum South, Copenhagen Trial Unit, Center for Clinical Intervention Research
Responsible party
Anna Lybeck (associate professor & senior consultant, anesthetics and intensive care, Region Skane) — Principal investigator
First posted
Sep 8, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jan 31, 2030 (estimated)
Completion
Jul 1, 2031 (estimated)
Last update
Sep 8, 2026

Study contacts

Anna Lybeck, MD PhD
Contact
anna.lybeck@med.lu.se
0771-11 14 44

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Naloxone

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