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

NCT ID: NCT03570099

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-11

Study Completion Date

2023-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Abuse

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective Naloxone cohort

The prospective cohort consists of study subjects receiving Naloxone nasal spray in the distribution program.

Naloxone Nasal Spray

Intervention Type DRUG

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.

Historical control cohort

Intervention Type OTHER

Historical data will be retrieved from quality registries.

Interventions

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Naloxone Nasal Spray

Naloxone Nasal Spray will be distributed at the addiction centres.

Intervention Type DRUG

Historical control cohort

Historical data will be retrieved from quality registries.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulf Malmqvist, MD, PhD

Role: STUDY_DIRECTOR

Region Skåne

Locations

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Malmö Addiction Center

Malmo, , Sweden

Site Status

Countries

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Sweden

References

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Troberg K, Isendahl P, Dahlman D, Hakansson A. Broad-scale overdose education and naloxone distribution- 5-year follow-up of a regional program in Skane County, Sweden. Harm Reduct J. 2025 Jun 5;22(1):97. doi: 10.1186/s12954-025-01255-3.

Reference Type DERIVED
PMID: 40474253 (View on PubMed)

Hakansson A, Alanko Blome M, Isendahl P, Landgren M, Malmqvist U, Troberg K. Distribution of intranasal naloxone to potential opioid overdose bystanders in Sweden: effects on overdose mortality in a full region-wide study. BMJ Open. 2024 Jan 3;14(1):e074152. doi: 10.1136/bmjopen-2023-074152.

Reference Type DERIVED
PMID: 38171623 (View on PubMed)

Troberg K, Isendahl P, Blome MA, Dahlman D, Hakansson A. Protocol for a multi-site study of the effects of overdose prevention education with naloxone distribution program in Skane County, Sweden. BMC Psychiatry. 2020 Feb 7;20(1):49. doi: 10.1186/s12888-020-2470-3.

Reference Type DERIVED
PMID: 32028921 (View on PubMed)

Other Identifiers

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2018/300

Identifier Type: -

Identifier Source: org_study_id

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