Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Study drug and medical condition

Name of medicine, other

naloxone Nasal Spray
naloxone Prefilled Syringe
naloxone Auto-Injector

Study drug International non-proprietary name (INN) or common name

NALOXONE HYDROCHLORIDE DIHYDRATE

Anatomical Therapeutic Chemical (ATC) code

(V03AB15) naloxone
naloxone

Additional medical condition(s)

Opioid-induced mood disorder due to opioid abuse, Intravenous nondependent opioid abuse, Nondependent opioid abuse (continuous and episodic), Opioid abuse, Nondependent opioid abuse, Opioid-induced mood disorder due to opioid dependence, Opioid dependence with current use, Opioid analgesic dependence, Opioid dependence, Episodic opioid dependence, Continuous opioid dependence, Combined opioid with other drug dependence, Fentanyl dependence, Methadone dependence, Opium dependence, Heroin dependence, Morphine dependence
Population studied

Short description of the study population

Population-level utilization of THN: All individuals present in the database in the period between 01/01/2017 and 31/12/2022 will be included in the analysis after 365 days of database history. Therefore, children aged <1year will be excluded.
Patient-level THN utilization: All “new” users of THN in the period between 01/01/2017 and 31/12/2022, with “new” users being defined as all people with a prescription THN within the study period, with at least 365 days of availability prior to the date of their THN prescription and no prescription of THN in the last 7 days (180 days for sensitivity analysis). Therefore, the same person can be a “new” user multiple times during the study period.

Age groups

Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

17700000
Study design details

Study design

- Population level cohort study
- New drug user cohort study

Main study objective

(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.
(ii) To provide summary baseline characteristics of “new” THN users
(iii) To study the use of THN in ”new” users

Data analysis plan

Population-level THN use: Annual period prevalence of THN use and annual incidence rates per 100,000 person years in (1) the general population and (2) among people with a recorded history of opioid use disorder (OUD). Patient-level THN use: Summary baseline characteristics of “new” users incl. demographics and history of opioid use, overdose will be conducted. Index date will be the date of the respective prescription of THN for each person. Number of THN prescriptions/packages per “new” user at index date will be summarised and mean (SD), median, p25 and p75 provided. For all analyses a minimum cell count of 5 will be used when reporting results, with any smaller counts obscured.
Documents
Study report
English (2.38 MB - PDF)View document