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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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