Opioid OverdoseNalPORSNCT05072249
European Cohort Study of the Effectiveness of Take Home Naloxone
An observational study of Opioid Overdose, run by King's College London at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Overdose
- What is being tested?
- Naloxone
- How many people
- 6,000 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 8 Jun 2021to 30 Dec 2023
- 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: 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
Who may be able to join
- 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.
Who cannot join
- The following persons will be excluded:
- Needs an interpreter
- Already entered the study
- Not willing or able to partake in follow-up telephone survey
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United Kingdom4 sites, 4 recruiting
- Recruiting
Birmingham and Solihull Mental Health Foundation Trust
Birmingham
Dr Day, e.j.day@bham.ac.uk
Dr Day
- Recruiting
Public Health Wales
Cardiff
Ms Smith, Josie.Smith@wales.nhs.uk
Ms Smith
- Recruiting
Scottish Drugs Forum
Glasgow
Ms Horsburgh, kirsten@sdf.org.uk
Ms Horsburgh
- Recruiting
South London and the Maudsley
London
Dr Kelleher, Mike.Kelleher@slam.nhs.uk
Dr Kelleher
Denmark1 site, 1 recruiting
- Not yet recruiting
SundhedsTeam, Socialforvaltningen, Københavns Kommune
Copenhagen
Dr Thiesen, GG63@kk.dk
Dr Thiesen
Sweden1 site, 1 recruiting
- Recruiting
Stockholm Centre for Dependency Disorders
Stockholm
Dr Martin Kåberg, martin.kaberg@sll.se
Dr Joar Guterstam, joar.guterstam@sll.se
About this study
Official title: A Multi-national, Prospective Mixed Methods Study of the Effectiveness of Naloxone (Including Intranasal Nyxoid) Administration by Lay People in Reversing Opioid Overdose
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.
Read the detailed description
Accidental opioid overdose is a global crisis. Naloxone is an accessible, safe and effective antidote for this preventable cause of mortality. While it has been used to treat opioid overdose in hospital and pre-hospital settings since the 1970s, take home naloxone programmes have been introduced more recently after opioid users were recognised as potential first responders. 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 (comprising four groups:1. patients in treatment for opioid use disorder (OUD), 2. Individuals using opioids but out-of-treatment, 3. family members, friends and other close carers, and 4. staff working with individuals with OUD) 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 two stages and two sub-studies. Main study stage 1: All consenting participants (n=6,000) will be asked to complete an enrolment questionnaire with the member of staff recruiting them into the study. In addition, the staff member will be asked to complete a brief record of the naloxone and training provided to the participant. Participants will be texted monthly to prompt them to contact research staff if they have witnessed an opioid overdose. Staff who have frequent or regular contact with participants (including instances when a replenishment of naloxone is given) will also prompt participants to make contact with research staff to notify them of a witnessed opioid overdose. All participants will be contacted at six months and asked to take part in a structured interview. In addition, national/regional death registers will be probed to confirm mortality data for study participants who are at risk of experiencing an opioid overdose themselves.
Main study, Stage 2: Participants who report that they have witnessed an opioid overdose during the six-month follow-up period will be asked to take part in a structured interview with a researcher about this witnessed overdose to capture our primary outcomes (approximately n=600).
Sub-study A: comprises two structured surveys incorporated into a) the Enrolment training information form (to examine naloxone training and materials provided) and b) the Stage 2 Interview completed by participants who have witnessed an overdose (to ask about the extent they followed the nasal naloxone Nyxoid Quick Start Guide (QSG) (or equivalent instructions). The questions are designed to better understand the effectiveness of the Nyxoid nasal naloxone educational and training materials delivered to participants who were provided with Nyxoid nasal naloxone and who were subsequently present at an overdose.
Sub-study B: comprises qualitative interviews with 60 UK participants who witness a diverse range of overdose events of the approx. n=600 (Main Study Stage 2). The aim of sub-study B is to better understand the use, safety, and effectiveness of different naloxone products. Qualitative interviews will be guided by a topic guide and conducted by telephone. The topic guide will capture details of any overdoses experienced or witnessed since the study started before focusing in more depth on the most recent overdose witnessed. Participants will also be asked about any training they have had, or need, in naloxone administration. In addition, a clinical expert assessment of the accurate identification of an opioid overdose and the participant's response to the opioid overdose (as detailed in the transcribed interviews) will be performed and documented. Answers will be assessed by an expert clinician panel for accuracy of diagnosis, actions taken and aftercare.
This study will report on the use of different formulations of naloxone, and different national systems of training and provision. 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
- Being tested
- Naloxone
- Keywords
- overdose, take home naloxone, opioids, effectiveness, prevention, fatalities, mixed methods
- Medical subject headings
- Opiate Overdose, Drug Overdose, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaloxoneDrug
Also called Prenoxad, Nyxoid, Ventizolve
Take Home Naloxone for reversing opioid overdose
| Study group | Role | What they receive |
|---|---|---|
| lay person provided with take home naloxone | Naloxone all forms Receives: Drug: Naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Percentage (n=6000)
Measured: Ongoing over 6-month period post enrolment
Percentage of participants who witness an opioid overdose over 6-month period.
Percentage (n=6000)
Measured: Ongoing over 6-month period post enrolment
Confirm death or survival of participants
percentage (n=600)
Measured: On-going over 6 month period post enrolment
Percentage of participants who witness an opioid overdose who report there was THN present
Percentage (n=600)
Measured: Ongoing over 6-month period post enrolment (at most recent overdose witnessed)
Percentage of participants who are carrying THN when witness an opioid overdose
Percentage (n=600)
Measured: Ongoing over 6-month period post enrolment (at most recent overdose witnessed)
Percentage of participants who witness an opioid overdose, where there was THN present, and administer THN
Percentage (n=600)
Measured: Ongoing over 6-month period post enrolment (at most recent overdose witnessed)
Percentage of participants who witness an overdose and administer THN who report respiratory depression occurred in person they resuscitated within one hour of administering THN
Percentage (n=600)
Measured: On-going within 6-month period post enrolment (at most recent overdose witnessed)
Percentage of participants who witness an overdose, who report a second dose of naloxone administered to a person experiencing an opioid overdose within 1-hour post administration of first dose of THN
Percentage (n=600)
Measured: 6-month follow-up (at most recent overdose witnessed)
Percentage of participants who report withdrawal symptoms (including anger, rage and violence) occurred in person they resuscitated with THN
Frequency of each symptom witnessed (n=600) (at most recent overdose witnessed)
Measured: On-going over 6-month period post enrolment (at most recent overdose witnessed)
Percentage of participants witnessing an overdose where the person receiving naloxone has survived at 2 hours post administration of naloxone OR at arrival of ambulance/medical assistance if this occurs before 2 hours have passed since opioid overdose
Percentage (n=600)
Measured: Ongoing over 6-month period post enrolment
Percentage of participants who witness an opioid overdose and report fatal outcomes within 2 hours of identification of opioid overdose or at arrival of ambulance/medical assistance a) of witnessed opioid overdoses b) Of witnessed opioid overdoses
Percentage (n=600)
Measured: Ongoing over 6-month period post enrolment
Percentage of participants who witness an overdose who correctly diagnosed opioid overdose crisis-through multiple response questions
Percentage (n=600)
Measured: Ongoing interviews 6-month post enrolment follow-up
Percentage of participants who witness an opioid overdose who correctly diagnose opioid overdose crisis-through multiple response questions
Percentage (n=600)
Measured: Ongoing interviews 6-month post enrolment follow-up
Percentage of participants who witness an opioid overdose who correctly respond to opioid overdose crisis-through multiple response questions
Percentage (n=600)
Measured: Ongoing interviews 6-month post enrolment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start8 Jun 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid OverdoseStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Mundipharma Research Limited
- Responsible party
- Sponsor
- Investigators
- Prof Sir John Strang, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072249
- Sponsor's protocol ID
- MR903 9501
- Acronym
- NalPORS
- Status last verified
- Mar 2023
- First submitted
- 8 Jun 2021
- 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
Metrebian N, Dascal T, Mackie C, Tinch-Taylor R, Carter B, Neale J, Utrilla MG, Day E, Guterstam J, Horsburgh K, Kaberg M, Kelleher M, Mayet S, Smith J, Eide D, Holmen E, McDonald R, Parkin S, Thiesen H, Strang J; NalPORS Research Team. Overdose reversal through peer intervention: Findings from the naloxone prospective outcome research study (NalPORS) on the effectiveness of overdose response by people who use opioids in the United Kingdom and Sweden. Addiction. 2026 Jul 12. doi: 10.1111/add.70526. Online ahead of print.
PubMed 42438068Metrebian 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.
PubMed 37612698
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
- A Multi-national, Prospective Mixed Methods Study of the Effectiveness of Naloxone (Including Intranasal Nyxoid) Administration by Lay People in Reversing Opioid Overdose
- ClinicalTrials.gov ID
- NCT05072249
- Acronym / sponsor ID
- NalPORS / MR903 9501
- Conditions
- Opioid Overdose
- Keywords
- overdose, take home naloxone, opioids, effectiveness, prevention, fatalities, mixed methods
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Mundipharma Research Limited
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 8 Oct 2021 (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.
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.
Detailed description
Accidental opioid overdose is a global crisis. Naloxone is an accessible, safe and effective antidote for this preventable cause of mortality. While it has been used to treat opioid overdose in hospital and pre-hospital settings since the 1970s, take home naloxone programmes have been introduced more recently after opioid users were recognised as potential first responders. 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 (comprising four groups:1. patients in treatment for opioid use disorder (OUD), 2. Individuals using opioids but out-of-treatment, 3. family members, friends and other close carers, and 4. staff working with individuals with OUD) 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 two stages and two sub-studies. Main study stage 1: All consenting participants (n=6,000) will be asked to complete an enrolment questionnaire with the member of staff recruiting them into the study. In addition, the staff member will be asked to complete a brief record of the naloxone and training provided to the participant. Participants will be texted monthly to prompt them to contact research staff if they have witnessed an opioid overdose. Staff who have frequent or regular contact with participants (including instances when a replenishment of naloxone is given) will also prompt participants to make contact with research staff to notify them of a witnessed opioid overdose. All participants will be contacted at six months and asked to take part in a structured interview. In addition, national/regional death registers will be probed to confirm mortality data for study participants who are at risk of experiencing an opioid overdose themselves.
Main study, Stage 2: Participants who report that they have witnessed an opioid overdose during the six-month follow-up period will be asked to take part in a structured interview with a researcher about this witnessed overdose to capture our primary outcomes (approximately n=600).
Sub-study A: comprises two structured surveys incorporated into a) the Enrolment training information form (to examine naloxone training and materials provided) and b) the Stage 2 Interview completed by participants who have witnessed an overdose (to ask about the extent they followed the nasal naloxone Nyxoid Quick Start Guide (QSG) (or equivalent instructions). The questions are designed to better understand the effectiveness of the Nyxoid nasal naloxone educational and training materials delivered to participants who were provided with Nyxoid nasal naloxone and who were subsequently present at an overdose.
Sub-study B: comprises qualitative interviews with 60 UK participants who witness a diverse range of overdose events of the approx. n=600 (Main Study Stage 2). The aim of sub-study B is to better understand the use, safety, and effectiveness of different naloxone products. Qualitative interviews will be guided by a topic guide and conducted by telephone. The topic guide will capture details of any overdoses experienced or witnessed since the study started before focusing in more depth on the most recent overdose witnessed. Participants will also be asked about any training they have had, or need, in naloxone administration. In addition, a clinical expert assessment of the accurate identification of an opioid overdose and the participant's response to the opioid overdose (as detailed in the transcribed interviews) will be performed and documented. Answers will be assessed by an expert clinician panel for accuracy of diagnosis, actions taken and aftercare.
This study will report on the use of different formulations of naloxone, and different national systems of training and provision. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lay person provided with take home naloxone | – | Drug: NaloxoneNaloxone all forms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Needs an interpreter
- Already entered the study
- Not willing or able to partake in follow-up telephone survey
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 |
|---|---|---|
| NaloxoneAlso: Prenoxad, Nyxoid, VentizolveTake Home Naloxone for reversing opioid overdose | Drug | lay person provided with take home naloxone |
Primary outcome
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.
Time frame: Ongoing - over six months period post enrolment (at most recent overdose witnessed)
frequency of deaths among those witnessing opioid overdose (n=600)
Administration rate of THN with the intention of reversing an opioid overdose by lay persons provided with THN who witness an opioid overdose.
Time frame: Ongoing -over six months period post enrolment (at most recent overdose witnessed)
Rate of THN administration among those witnessing opioid overdose (n=600)
14 secondary outcomes
Percentage of participants who indicate carrying THN (on day of interview)
Time frame: Ongoing over 6-month period post enrolment
Percentage of participants who witness an opioid overdose over 6-month period.
Time frame: Ongoing over 6-month period post enrolment
Confirm death or survival of participants
Time frame: On-going over 6 month period post enrolment
Percentage of participants who witness an opioid overdose who report there was THN present
Time frame: Ongoing over 6-month period post enrolment (at most recent overdose witnessed)
Percentage of participants who are carrying THN when witness an opioid overdose
Time frame: Ongoing over 6-month period post enrolment (at most recent overdose witnessed)
Percentage of participants who witness an opioid overdose, where there was THN present, and administer THN
Time frame: Ongoing over 6-month period post enrolment (at most recent overdose witnessed)
Percentage of participants who witness an overdose and administer THN who report respiratory depression occurred in person they resuscitated within one hour of administering THN
Time frame: On-going within 6-month period post enrolment (at most recent overdose witnessed)
Percentage of participants who witness an overdose, who report a second dose of naloxone administered to a person experiencing an opioid overdose within 1-hour post administration of first dose of THN
Time frame: 6-month follow-up (at most recent overdose witnessed)
Percentage of participants who report withdrawal symptoms (including anger, rage and violence) occurred in person they resuscitated with THN
Time frame: On-going over 6-month period post enrolment (at most recent overdose witnessed)
Percentage of participants witnessing an overdose where the person receiving naloxone has survived at 2 hours post administration of naloxone OR at arrival of ambulance/medical assistance if this occurs before 2 hours have passed since opioid overdose
Time frame: Ongoing over 6-month period post enrolment
Percentage of participants who witness an opioid overdose and report fatal outcomes within 2 hours of identification of opioid overdose or at arrival of ambulance/medical assistance a) of witnessed opioid overdoses b) Of witnessed opioid overdoses
Time frame: Ongoing over 6-month period post enrolment
Percentage of participants who witness an overdose who correctly diagnosed opioid overdose crisis-through multiple response questions
Time frame: Ongoing interviews 6-month post enrolment follow-up
Percentage of participants who witness an opioid overdose who correctly diagnose opioid overdose crisis-through multiple response questions
Time frame: Ongoing interviews 6-month post enrolment follow-up
Percentage of participants who witness an opioid overdose who correctly respond to opioid overdose crisis-through multiple response questions
Time frame: Ongoing interviews 6-month post enrolment follow-up
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 42438068Metrebian N, Dascal T, Mackie C, Tinch-Taylor R, Carter B, Neale J, Utrilla MG, Day E, Guterstam J, Horsburgh K, Kaberg M, Kelleher M, Mayet S, Smith J, Eide D, Holmen E, McDonald R, Parkin S, Thiesen H, Strang J; NalPORS Research Team. Overdose reversal through peer intervention: Findings from the naloxone prospective outcome research study (NalPORS) on the effectiveness of overdose response by people who use opioids in the United Kingdom and Sweden. Addiction. 2026 Jul 12. doi: 10.1111/add.70526. Online ahead of print.
- Derived from this study: PubMed 37612698Metrebian 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.
- 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.
Prof Sir John Strang principal investigator
King's College London
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Overdose, run by King's College London at 6 sites in 3 countries.
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 6 inclusion and 4 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 6 sites in United Kingdom, Denmark, 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?
Contact Dr Metrebian (07957757235, nicola.metrebian@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Ongoing - over six months period post enrolment (at most recent overdose witnessed)). The study lists 2 primary outcomes in all. 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 NCT05072249, which also lists 2 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.