Study identification

PURI

https://redirect.ema.europa.eu/resource/106379

EU PAS number

EUPAS105644

Study ID

106379

Official title and acronym

DARWIN EU® Use of take-home naloxone for opioid overdose treatment

DARWIN EU® study

Yes

Study countries

Belgium
Germany
Spain
United Kingdom

Study description

Opioid overdoses are the primary cause of mortality among problematic drug users globally. Naloxone, an opioid antagonist, can avert such fatalities by rapidly counteracting opioid effects. To address the frequent untreated overdoses due to the lack of recognition, fear of legal consequences, and lack of naloxone access, Take-Home Naloxone (THN) programs have been established, providing naloxone to potential bystanders in 12 European countries. This study will investigate the trend of naloxone use, particularly THN, across Europe, and elucidate user profiles to augment aggregated data from existing THN programs, thereby aiding the monitoring of naloxone use and informing regulatory decisions.
The objectives of this study are (i) To investigate the incidence and prevalence of THN use in (1) the general population and (2) among people with a recorded history of opioid use disorder during the study period 2017-2022. Analyses will be stratified by age, sex, calendar year and country/database. (ii) To provide summary baseline characteristics of “new” THN users including demographics, previous medical history, previous medication use and history of opioid use, overdose (iii) To study the use of THN in ”new” users including summary statistics of number of THN packages prescribed at index date for each “new” user (e.g. mean (SD), median, q25 and q75).

Study status

Finalised
Research institution and networks

Institutions

Networks

Contact details

Annika Jodicke

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

Study Protocol P2 C1-004 Version 2.1 final

English (1.63 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable