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

Nicola Metrebian; Ben Carter; Desiree Eide; Rebecca McDonald; Joanne Neale; Stephen Parkin; Teodora Dascal; Clare Mackie; Ed Day; Joar Guterstam; Kirsten Horsburgh; Martin Kåberg; Mike Kelleher; Josie Smith; Henrik Thiesen; John Strang

doi:10.1186/s12889-023-16445-6

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

Nicola Metrebian, Ben Carter, Desiree Eide, Rebecca McDonald, Joanne Neale, Stephen Parkin, Teodora Dascal, Clare Mackie, Ed Day, Joar Guterstam, Kirsten Horsburgh, Martin Kåberg, Mike Kelleher, Josie Smith, Henrik Thiesen, John Strang^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

Background: Worldwide, opioid use causes more than 100,000 overdose deaths annually. Naloxone has proven efficacy in reversing opioid overdoses and is approved as an emergency antidote to opioid overdose. Take home naloxone (THN) programmes have been introduced to provide ‘community members’, who are likely to observe opioid overdoses, with naloxone kits and train them to recognise an overdose and administer naloxone. The acceptability and feasibility of THN programmes has been demonstrated, but the real-life effectiveness of naloxone administration by community members is not known. In recent years, the approval of several concentrated naloxone nasal-spray formulations (in addition to injectable formulations, eg.prenoxad) potentially increases acceptability and scope for wider provision. This study aims to determine the effectiveness of THN (all formulations) in real-world conditions.

Methods: A European, multi-country, prospective cohort study, to assess the use of THN by community members to reverse opioid overdoses in a six-month, follow-up period. Participants provided with THN from participating harm reduction and drug treatment sites will be recruited to the study and followed-up for six months. We are particularly interested in the experiences of community members who have been provided with THN and have witnessed an opioid overdose. All participants who witness an opioid overdose during the six-month period (target approx. 600) will be asked to take part in a structured interview about this event. Of these, 60 will be invited to participate in a qualitative interview. A Post Authorisation Efficacy Study (PAES) for the concentrated nasal naloxone, Nyxoid, has been integrated into the study design.

Discussion: There are many challenges involved in evaluating the real-life effectiveness of THN. It is not possible to use a randomised trial design, recruitment of community members provided with THN will depend upon recruitment sites distributing THN kits, and the type of THN received by participants will depend on regulations and on local clinical and policy decision-makers. Following up this population, some of whom may be itinerant, over the 6-month study period will be challenging, but we plan to maintain contact with participants through regular text message reminders and staff contact.

Trial registration: ClinicalTrials.gov Identifier: NCT05072249. Date of Registration: 8.10.2021

Original language	English
Article number	1608
Journal	BMC Public Health
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s12889-023-16445-6
Publication status	Published - 24 Aug 2023

Bibliographical note

Funding Information:
Nicola Metrebian: received, through her university, King’s College London, research funding from Mundipharma Research Ltd (pharmaceutical company that produces a naloxone nasal spray). She has also received, through her university, consultancy payment from an agency for Mayne Pharma International, on another area of research not relevant to the article under consideration.

Rebecca McDonald: indirectly received, through her former employer King’s College London, funding from Mundipharma Research Ltd that supported her position of employment (2019–21). RM was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London.

Stephen Parkin: received funding, as part of his employment within King’s College London, funding from Mundipharma Research Ltd, and Camurus AB pharmaceutical company and The Pilgrim Trust. SP was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London.

Joanne Neale: received, through her university, research funding from Mundipharma Research Ltd and Camurus AB for unrelated research and an honorarium from Indivior for an unrelated conference presentation. JN was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London.

Publisher Copyright:
© 2023, BioMed Central Ltd., part of Springer Nature.

Keywords

Death
Emergency
Heroin
Mortality
Naloxone
Opioid overdose
Resuscitation
Take home naloxone

ASJC Scopus subject areas

Public Health, Environmental and Occupational Health

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Cite this

Metrebian, N., Carter, B., Eide, D., McDonald, R., Neale, J., Parkin, S., Dascal, T., Mackie, C., Day, E., Guterstam, J., Horsburgh, K., Kåberg, M., Kelleher, M., Smith, J., Thiesen, H., & Strang, J. (2023). 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, 23(1), Article 1608. https://doi.org/10.1186/s12889-023-16445-6

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abstract = "Background: Worldwide, opioid use causes more than 100,000 overdose deaths annually. Naloxone has proven efficacy in reversing opioid overdoses and is approved as an emergency antidote to opioid overdose. Take home naloxone (THN) programmes have been introduced to provide {\textquoteleft}community members{\textquoteright}, who are likely to observe opioid overdoses, with naloxone kits and train them to recognise an overdose and administer naloxone. The acceptability and feasibility of THN programmes has been demonstrated, but the real-life effectiveness of naloxone administration by community members is not known. In recent years, the approval of several concentrated naloxone nasal-spray formulations (in addition to injectable formulations, eg.prenoxad) potentially increases acceptability and scope for wider provision. This study aims to determine the effectiveness of THN (all formulations) in real-world conditions. Methods: A European, multi-country, prospective cohort study, to assess the use of THN by community members to reverse opioid overdoses in a six-month, follow-up period. Participants provided with THN from participating harm reduction and drug treatment sites will be recruited to the study and followed-up for six months. We are particularly interested in the experiences of community members who have been provided with THN and have witnessed an opioid overdose. All participants who witness an opioid overdose during the six-month period (target approx. 600) will be asked to take part in a structured interview about this event. Of these, 60 will be invited to participate in a qualitative interview. A Post Authorisation Efficacy Study (PAES) for the concentrated nasal naloxone, Nyxoid, has been integrated into the study design. Discussion: There are many challenges involved in evaluating the real-life effectiveness of THN. It is not possible to use a randomised trial design, recruitment of community members provided with THN will depend upon recruitment sites distributing THN kits, and the type of THN received by participants will depend on regulations and on local clinical and policy decision-makers. Following up this population, some of whom may be itinerant, over the 6-month study period will be challenging, but we plan to maintain contact with participants through regular text message reminders and staff contact. Trial registration: ClinicalTrials.gov Identifier: NCT05072249. Date of Registration: 8.10.2021",

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note = "Funding Information: Nicola Metrebian: received, through her university, King{\textquoteright}s College London, research funding from Mundipharma Research Ltd (pharmaceutical company that produces a naloxone nasal spray). She has also received, through her university, consultancy payment from an agency for Mayne Pharma International, on another area of research not relevant to the article under consideration. Rebecca McDonald: indirectly received, through her former employer King{\textquoteright}s College London, funding from Mundipharma Research Ltd that supported her position of employment (2019–21). RM was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King{\textquoteright}s College London. Stephen Parkin: received funding, as part of his employment within King{\textquoteright}s College London, funding from Mundipharma Research Ltd, and Camurus AB pharmaceutical company and The Pilgrim Trust. SP was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King{\textquoteright}s College London. Joanne Neale: received, through her university, research funding from Mundipharma Research Ltd and Camurus AB for unrelated research and an honorarium from Indivior for an unrelated conference presentation. JN was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King{\textquoteright}s College London. Publisher Copyright: {\textcopyright} 2023, BioMed Central Ltd., part of Springer Nature.",

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Metrebian, N, Carter, B, Eide, D, McDonald, R, Neale, J, Parkin, S, Dascal, T, Mackie, C, Day, E, Guterstam, J, Horsburgh, K, Kåberg, M, Kelleher, M, Smith, J, Thiesen, H & Strang, J 2023, '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, vol. 23, no. 1, 1608. https://doi.org/10.1186/s12889-023-16445-6

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T1 - A study protocol for a European, mixed methods, prospective, cohort study of the effectiveness of naloxone administration by community members, in reversing opioid overdose

T2 - NalPORS

AU - Metrebian, Nicola

AU - Carter, Ben

AU - Eide, Desiree

AU - McDonald, Rebecca

AU - Neale, Joanne

AU - Parkin, Stephen

AU - Dascal, Teodora

AU - Mackie, Clare

AU - Day, Ed

AU - Guterstam, Joar

AU - Horsburgh, Kirsten

AU - Kåberg, Martin

AU - Kelleher, Mike

AU - Smith, Josie

AU - Thiesen, Henrik

AU - Strang, John

N1 - Funding Information: Nicola Metrebian: received, through her university, King’s College London, research funding from Mundipharma Research Ltd (pharmaceutical company that produces a naloxone nasal spray). She has also received, through her university, consultancy payment from an agency for Mayne Pharma International, on another area of research not relevant to the article under consideration. Rebecca McDonald: indirectly received, through her former employer King’s College London, funding from Mundipharma Research Ltd that supported her position of employment (2019–21). RM was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London. Stephen Parkin: received funding, as part of his employment within King’s College London, funding from Mundipharma Research Ltd, and Camurus AB pharmaceutical company and The Pilgrim Trust. SP was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London. Joanne Neale: received, through her university, research funding from Mundipharma Research Ltd and Camurus AB for unrelated research and an honorarium from Indivior for an unrelated conference presentation. JN was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London. Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.

PY - 2023/8/24

Y1 - 2023/8/24

N2 - Background: Worldwide, opioid use causes more than 100,000 overdose deaths annually. Naloxone has proven efficacy in reversing opioid overdoses and is approved as an emergency antidote to opioid overdose. Take home naloxone (THN) programmes have been introduced to provide ‘community members’, who are likely to observe opioid overdoses, with naloxone kits and train them to recognise an overdose and administer naloxone. The acceptability and feasibility of THN programmes has been demonstrated, but the real-life effectiveness of naloxone administration by community members is not known. In recent years, the approval of several concentrated naloxone nasal-spray formulations (in addition to injectable formulations, eg.prenoxad) potentially increases acceptability and scope for wider provision. This study aims to determine the effectiveness of THN (all formulations) in real-world conditions. Methods: A European, multi-country, prospective cohort study, to assess the use of THN by community members to reverse opioid overdoses in a six-month, follow-up period. Participants provided with THN from participating harm reduction and drug treatment sites will be recruited to the study and followed-up for six months. We are particularly interested in the experiences of community members who have been provided with THN and have witnessed an opioid overdose. All participants who witness an opioid overdose during the six-month period (target approx. 600) will be asked to take part in a structured interview about this event. Of these, 60 will be invited to participate in a qualitative interview. A Post Authorisation Efficacy Study (PAES) for the concentrated nasal naloxone, Nyxoid, has been integrated into the study design. Discussion: There are many challenges involved in evaluating the real-life effectiveness of THN. It is not possible to use a randomised trial design, recruitment of community members provided with THN will depend upon recruitment sites distributing THN kits, and the type of THN received by participants will depend on regulations and on local clinical and policy decision-makers. Following up this population, some of whom may be itinerant, over the 6-month study period will be challenging, but we plan to maintain contact with participants through regular text message reminders and staff contact. Trial registration: ClinicalTrials.gov Identifier: NCT05072249. Date of Registration: 8.10.2021

AB - Background: Worldwide, opioid use causes more than 100,000 overdose deaths annually. Naloxone has proven efficacy in reversing opioid overdoses and is approved as an emergency antidote to opioid overdose. Take home naloxone (THN) programmes have been introduced to provide ‘community members’, who are likely to observe opioid overdoses, with naloxone kits and train them to recognise an overdose and administer naloxone. The acceptability and feasibility of THN programmes has been demonstrated, but the real-life effectiveness of naloxone administration by community members is not known. In recent years, the approval of several concentrated naloxone nasal-spray formulations (in addition to injectable formulations, eg.prenoxad) potentially increases acceptability and scope for wider provision. This study aims to determine the effectiveness of THN (all formulations) in real-world conditions. Methods: A European, multi-country, prospective cohort study, to assess the use of THN by community members to reverse opioid overdoses in a six-month, follow-up period. Participants provided with THN from participating harm reduction and drug treatment sites will be recruited to the study and followed-up for six months. We are particularly interested in the experiences of community members who have been provided with THN and have witnessed an opioid overdose. All participants who witness an opioid overdose during the six-month period (target approx. 600) will be asked to take part in a structured interview about this event. Of these, 60 will be invited to participate in a qualitative interview. A Post Authorisation Efficacy Study (PAES) for the concentrated nasal naloxone, Nyxoid, has been integrated into the study design. Discussion: There are many challenges involved in evaluating the real-life effectiveness of THN. It is not possible to use a randomised trial design, recruitment of community members provided with THN will depend upon recruitment sites distributing THN kits, and the type of THN received by participants will depend on regulations and on local clinical and policy decision-makers. Following up this population, some of whom may be itinerant, over the 6-month study period will be challenging, but we plan to maintain contact with participants through regular text message reminders and staff contact. Trial registration: ClinicalTrials.gov Identifier: NCT05072249. Date of Registration: 8.10.2021

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KW - Emergency

KW - Heroin

KW - Mortality

KW - Naloxone

KW - Opioid overdose

KW - Resuscitation

KW - Take home naloxone

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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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

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