Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications

March 28, 2023 updated by: Region Skane
Death in overdose is the single most common cause of death in people using heroin. In Sweden, the number of drug-related overdose deaths has increased gradually since the early 1990s. The purpose of the study is to investigate the effects of a Naloxone distribution program in Skåne County. The primary issue is whether the project had an effect on overdose mortality and overdose related injuries.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden
        • Malmö Addiction Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of subjects treated at the Addiction centres of Skåne County. Naloxone Nasal Spray will be handed out to these subjects, who must be able to understand the given information about the use of the drug.

Description

Inclusion Criteria:

  • subjects treated at the Addiction centres of Skåne County
  • signed informed consent

Exclusion Criteria:

  • subjects unable to understand study information due to psychiatric co-morbidity or severe language difficulties

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospective Naloxone cohort
The prospective cohort consists of study subjects receiving Naloxone nasal spray in the distribution program.
Drug: Naloxone Nasal Spray
Naloxone Nasal Spray will be distributed at the addiction centres.
Historical control cohort
Data from the historical control cohort will be collected from national registries years 2013-2017.
Other: Historical control cohort
Historical data will be retrieved from quality registries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overdose mortality in the general population
Time Frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Overdose mortality deaths 2019-2023 to be compared with historical overdose mortality during 2013-2017. Number of deaths will be collected from national registries.
5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reaction level of ambulance-attended opioid overdose survivors in the general population
Time Frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Assessment of responsiveness in acute brain disorders using Reaction Level Scale (RLS-85) in ambulance. The RLS scale is graded from 1 (awake, no delayed reaction, oriented) to grade 8 (unconscious, no movements to painful stimuli).
5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Respiratory rate of ambulance-attended opioid overdose survivors in the general population
Time Frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Respiratory rate (breaths per minute) registered in ambulance.
5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Heart rate of ambulance-attended opioid overdose survivors in the general population
Time Frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Heart rate (beats per minute) of opioid overdose survivors registered in ambulance.
5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Naloxone or other antidot administered by ambulance staff to ambulance-attended opioid overdose survivors in the general population
Time Frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Naloxone or other antidot, if needed, administered by ambulance staff in opioid overdose survivors.
5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Need of ambulance transport to hospital of ambulance-attended opioid overdose survivors in the general population
Time Frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
The need to transport the opioid overdose survivors to hospital - information registered in ambulance.
5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Incidence of opioid overdoses attended by ambulance or emergency hospital care
Time Frame: 5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
Incidence of opioid overdoses attended by ambulance or emergency hospital care, information registered in ambulance or emergency hospital care.
5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)
All cause mortality in included patients
Time Frame: 3 years
Number of deaths will be collected from national and regional registries.
3 years
Overdose mortality in included patients
Time Frame: 3 years
Overdose mortality in included patients. Number of deaths will be collected from national and regional registries.
3 years
Retention in naloxone program
Time Frame: 3 years
Retention in naloxone program - number of patients.
3 years
Incidence of witnessing opioid overdoses
Time Frame: 3 years
Number of incidences of witnessing opioid overdoses.
3 years
Incidence in naloxone use and bystander CPR
Time Frame: 3 years
Number of incidences of naloxone use and bystander CPR.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Study Director: Ulf Malmqvist, MD, PhD, Region Skane

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

June 15, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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