Opioid AbuseNCT03570099
Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
An observational study of Opioid Abuse, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Abuse
- What is being tested?
- Naloxone Nasal Spray
- How many people
- 2,000 participants
- Where
- 1 siteSweden
- Study dates
- 11 Jun 2018to 1 Jul 2023
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- subjects treated at the Addiction centres of Skåne County
- signed informed consent
Who cannot join
- subjects unable to understand study information due to psychiatric co-morbidity or severe language difficulties
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Naloxone Nasal Spray, Historical control cohort
- Keywords
- opioid overdose, mortality, naloxone, substance use disorder, prevention
- Medical subject headings
- Opioid-Related Disorders, Opiate Overdose, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naloxone Nasal SprayDrug
Naloxone Nasal Spray will be distributed at the addiction centres.
Historical control cohortOther
Historical data will be retrieved from quality registries.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Naloxone cohort | The prospective cohort consists of study subjects receiving Naloxone nasal spray in the distribution program. Receives: Drug: Naloxone Nasal Spray | |
| Historical control cohort | Data from the historical control cohort will be collected from national registries years 2013-2017. Receives: Other: Historical control cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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
Respiratory rate (breaths per minute) registered in ambulance.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Overdose mortality in included patients
Overdose mortality in included patients. Number of deaths will be collected from national and regional registries.
Measured: 3 years
Retention in naloxone program
Retention in naloxone program - number of patients.
Measured: 3 years
Incidence of witnessing opioid overdoses
Number of incidences of witnessing opioid overdoses.
Measured: 3 years
Incidence in naloxone use and bystander CPR
Number of incidences of naloxone use and bystander CPR.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start11 Jun 2018
- Primary completion31 Dec 2020
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Opioid AbuseStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulf Malmqvist, MD, PhD, Study director, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570099
- Sponsor's protocol ID
- 2018/300
- Status last verified
- Mar 2023
- First submitted
- 15 Jun 2018
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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;23(1):112. doi: 10.1186/s12954-026-01487-x.
PubMed 42337551Troberg 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.
PubMed 40474253Hakansson 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.
PubMed 38171623Troberg 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.
PubMed 32028921
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
- ClinicalTrials.gov ID
- NCT03570099
- Acronym / sponsor ID
- 2018/300
- Conditions
- Opioid Abuse
- Keywords
- opioid overdose, mortality, naloxone, substance use disorder, prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Naloxone cohort | – | Drug: Naloxone Nasal SprayThe prospective cohort consists of study subjects receiving Naloxone nasal spray in the distribution program. |
| Historical control cohort | – | Other: Historical control cohortData from the historical control cohort will be collected from national registries years 2013-2017. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- subjects treated at the Addiction centres of Skåne County
- signed informed consent
Key exclusion criteria (1 listed)
- subjects unable to understand study information due to psychiatric co-morbidity or severe language difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naloxone Nasal SprayNaloxone Nasal Spray will be distributed at the addiction centres. | Drug | Prospective Naloxone cohort |
| Historical control cohortHistorical data will be retrieved from quality registries. | Other | Historical control cohort |
Primary outcome
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.
11 secondary outcomes
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)
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)
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)
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)
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)
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)
All cause mortality in included patients
Time frame: 3 years
Overdose mortality in included patients
Time frame: 3 years
Retention in naloxone program
Time frame: 3 years
Incidence of witnessing opioid overdoses
Time frame: 3 years
Incidence in naloxone use and bystander CPR
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 42337551Troberg 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;23(1):112. doi: 10.1186/s12954-026-01487-x.
- Derived from this study: PubMed 40474253Troberg 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.
- Derived from this study: PubMed 38171623Hakansson 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.
- Derived from this study: PubMed 32028921Troberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Malmqvist, MD, PhD study director
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Abuse, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03570099, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.