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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Naloxone cohort | The prospective cohort consists of study subjects receiving Naloxone nasal spray in the distribution program. |
| |
| Historical control cohort | Data from the historical control cohort will be collected from national registries years 2013-2017. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxone Nasal Spray | Drug | Naloxone Nasal Spray will be distributed at the addiction centres. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Reaction level of ambulance-attended opioid overdose survivors in the general population | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ulf Malmqvist, MD, PhD | Region Skane | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malmö Addiction Center | Malmö | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42337551 | Derived | Troberg K, Isendahl P. "You've involved us knowing that we don't think about the law like you": a qualitative study on Supersavers' perspective of overdose engagement in Skane county, South Sweden. Harm Reduct J. 2026 Jun 23. doi: 10.1186/s12954-026-01487-x. Online ahead of print. | |
| 40474253 | Derived | 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. |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000083682 | Opiate Overdose |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D062787 | Drug Overdose |
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| Historical control cohort | Other | Historical data will be retrieved from quality registries. |
|
| Respiratory rate of ambulance-attended opioid overdose survivors in the general population | 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 | 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 | 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 | 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 | 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 | Number of deaths will be collected from national and regional registries. | 3 years |
| Overdose mortality in included patients | Overdose mortality in included patients. Number of deaths will be collected from national and regional registries. | 3 years |
| Retention in naloxone program | Retention in naloxone program - number of patients. | 3 years |
| Incidence of witnessing opioid overdoses | Number of incidences of witnessing opioid overdoses. | 3 years |
| Incidence in naloxone use and bystander CPR | Number of incidences of naloxone use and bystander CPR. | 3 years |
| 38171623 | 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. |
| 32028921 | 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. |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |