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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03570099
Recruitment Status : Active, not recruiting
First Posted : June 26, 2018
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Region Skane

Study Description
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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.

Condition or disease Intervention/treatment
Opioid Abuse Drug: Naloxone Nasal Spray Other: Historical control cohort

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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. 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.

  6. 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.

  7. All cause mortality in included patients [ Time Frame: 3 years ]
    Number of deaths will be collected from national and regional registries.

  8. 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.

  9. Retention in naloxone program [ Time Frame: 3 years ]
    Retention in naloxone program - number of patients.

  10. Incidence of witnessing opioid overdoses [ Time Frame: 3 years ]
    Number of incidences of witnessing opioid overdoses.

  11. Incidence in naloxone use and bystander CPR [ Time Frame: 3 years ]
    Number of incidences of naloxone use and bystander CPR.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570099


Locations
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Sweden
Malmö Addiction Center
Malmö, Sweden
Sponsors and Collaborators
Region Skane
Investigators
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Study Director: Ulf Malmqvist, MD, PhD Region Skåne
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03570099    
Other Study ID Numbers: 2018/300
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Skane:
opioid overdose
mortality
naloxone
substance use disorder
prevention
Additional relevant MeSH terms:
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Drug Overdose
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Narcotic-Related Disorders
Mental Disorders
 Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents