European Cohort Study of the Effectiveness of Take Home Naloxone

NCT05072249 | Unknown

• 1 other identifier: MR903 9501
• Study Type: observational
• Target: 6,000
• Locations: 3 countries
• Sites: 6

Brief Summary

This study aims to assess the effectiveness of take-home naloxone (THN) to reverse opioid overdose when administered by lay persons in a real world setting. This multicentre, prospective, observational cohort study will be conducted across Europe using a mixed method approach. Recruiting 6000 individuals to whom a supply of THN has been provided, for n=600 to witness an opioid overdose. The co-primary outcomes are to determine the rate of administration of naloxone and frequency of deaths in the 24 hours subsequent to the administration of naloxone. This will be captured through structured interviews with those who report witnessing an opioid overdose in the 6 month study period, approximately n=600, to elicit further information on the overdose and any naloxone administered. Naloxone training materials and education provided will be examined through questions in the structured interview. In-depth qualitative interviews will also be conducted with 60 participants who have witnessed an overdose, in order to better understand the use, safety and effectiveness of different naloxone products (particularly Nyxoid). As part of the qualitative analysis, interview transcripts will be assessed by an expert clinician panel for accuracy of diagnosis, actions taken and aftercare. Routine data from national health registers will be used to gather mortality data. This study will report on the use of different formulations of naloxone. In addition, this study serves as a Post Authorisation Efficacy Study (PAES) for the intranasal (IN) naloxone, Nyxoid developed by MundiPharma and focuses on drug safety and training.

Conditions

Opioid Overdose

Keywords

overdose; take home naloxone; opioids; effectiveness; prevention; fatalities; mixed methods

Outcome Measures

Primary Outcomes (2)

• Frequency of deaths in the 24 hours or later if information is available subsequent to administration of naloxone by lay-persons to reverse an opioid overdose in the real world.

  frequency of deaths among those witnessing opioid overdose (n=600)

  Ongoing - over six months period post enrolment (at most recent overdose witnessed)

• Administration rate of THN with the intention of reversing an opioid overdose by lay persons provided with THN who witness an opioid overdose.

  Rate of THN administration among those witnessing opioid overdose (n=600)

  Ongoing -over six months period post enrolment (at most recent overdose witnessed)

Secondary Outcomes (14)

• Percentage of participants who indicate carrying THN (on day of interview)

  Ongoing over 6-month period post enrolment

• Percentage of participants who witness an opioid overdose over 6-month period.

  Ongoing over 6-month period post enrolment

• Confirm death or survival of participants

  On-going over 6 month period post enrolment

• Percentage of participants who witness an opioid overdose who report there was THN present

  Ongoing over 6-month period post enrolment (at most recent overdose witnessed)

• Percentage of participants who are carrying THN when witness an opioid overdose

  Ongoing over 6-month period post enrolment (at most recent overdose witnessed)

Other Outcomes (20)

• Percentage of participants that received various forms of Nyxoid training materials during their naloxone training (patient information card, training video, information on leaflet and images in nyxoid pack).

  Enrolment & Stage 1 interview conducted at 6 months

• Percentage of participants (receiving nyxoid) that appropriately recognised and responded to an overdose.

  Ongoing interviews 6-months post enrolment follow-up

• Percentage of participants (receiving nyxoid) that appropriately responded to an overdose.

  Ongoing interviews 6-months post enrolment follow-up

Study Arms (1)

lay person provided with take home naloxone

Naloxone all forms

Drug: Naloxone

Interventions

Naloxone DRUG

Take Home Naloxone for reversing opioid overdose

Also known as: Prenoxad, Nyxoid, Ventizolve

lay person provided with take home naloxone

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

Any of below: 1. Patients in treatment for opioid use disorder (OUD) 2. Out-of-treatment individuals with OUD 3. Family members, friends and other close carers of individuals with OUD 4. Staff working with individuals with OUD

You may qualify if:

• Member of at least one of the groups above (a-d)
• Aged ≥18 years
• Provided with THN supply at time of enrolment (or can demonstrate that they have a supply of THN (in-date) and have received training at time of enrolment).
• Have access to reliable mobile telephone and can present it.
• Willing to participate in follow-up
• Who have provided written informed consent.

You may not qualify if:

• The following persons will be excluded:
• Needs an interpreter
• Already entered the study
• Not willing or able to partake in follow-up telephone survey

Sponsors & Collaborators

• King's College London: lead
• Mundipharma Research Limited: collaborator

Study Sites (6)

SundhedsTeam, Socialforvaltningen, Københavns Kommune

Copenhagen, Denmark

NOT YET RECRUITING

Stockholm Centre for Dependency Disorders

Stockholm, Sweden

RECRUITING

Birmingham and Solihull Mental Health Foundation Trust

Birmingham, United Kingdom

RECRUITING

Public Health Wales

Cardiff, United Kingdom

RECRUITING

Scottish Drugs Forum

Glasgow, United Kingdom

RECRUITING

South London and the Maudsley

London, United Kingdom

RECRUITING

Related Publications (1)

• Metrebian N, Carter B, Eide D, McDonald R, Neale J, Parkin S, Dascal T, Mackie C, Day E, Guterstam J, Horsburgh K, Kaberg M, Kelleher M, Smith J, Thiesen H, Strang J. A study protocol for a European, mixed methods, prospective, cohort study of the effectiveness of naloxone administration by community members, in reversing opioid overdose: NalPORS. BMC Public Health. 2023 Aug 24;23(1):1608. doi: 10.1186/s12889-023-16445-6.

  PMID: 37612698 DERIVED

MeSH Terms

Conditions

Opiate Overdose; Drug Overdose; Death

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Prof Sir John Strang

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Metrebian

CONTACT

07957757235; nicola.metrebian@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: October 8, 2021
• Study Start: June 8, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); DK (1); GB (4)