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

NCT03570099 | Unknown

• 1 other identifier: 2018/300
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Abuse

Keywords

opioid overdose; mortality; naloxone; substance use disorder; prevention

Outcome Measures

Primary Outcomes (1)

• Overdose mortality in the general population

  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 Outcomes (11)

• Reaction level of ambulance-attended opioid overdose survivors in the general population

  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

  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

  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

  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

  5 years (first outcome measure for the 18-month intervention period July 1, 2019 - Dec 31, 2020)

Study Arms (2)

Prospective Naloxone cohort

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

Drug: Naloxone Nasal Spray

Historical control cohort

Data from the historical control cohort will be collected from national registries years 2013-2017.

Other: Historical control cohort

Interventions

Naloxone Nasal Spray DRUG

Naloxone Nasal Spray will be distributed at the addiction centres.

Prospective Naloxone cohort

Historical control cohort OTHER

Historical data will be retrieved from quality registries.

Historical control cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Malmö Addiction Center

Malmo, Sweden

Location

Related Publications (3)

• 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.

  PMID: 40474253 DERIVED

• 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.

  PMID: 38171623 DERIVED

• 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.

  PMID: 32028921 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Opiate Overdose; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drug Overdose; Prescription Drug Misuse; Drug Misuse

Study Officials

• Ulf Malmqvist, MD, PhD

  Region Skåne

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 26, 2018
• Study Start: June 11, 2018
• Primary Completion: December 31, 2020
• Study Completion: July 1, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)