Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications

Region Skane

Status: Active, not recruiting

Conditions: Opioid Abuse

Treatments: Drug: Naloxone Nasal Spray; Other: Historical control cohort

Study type: Observational

Funder types: Other

Identifiers

NCT03570099

2018/300

Details and patient eligibility

About

Death in overdose is the single most common cause of death in people using heroin. In Sweden, the number of drug-related overdose deaths has increased gradually since the early 1990s. The purpose of the study is to investigate the effects of a Naloxone distribution program in Skåne County. The primary issue is whether the project had an effect on overdose mortality and overdose related injuries.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects treated at the Addiction centres of Skåne County
• signed informed consent

Exclusion criteria

• subjects unable to understand study information due to psychiatric co-morbidity or severe language difficulties

Trial design

2,000 participants in 2 patient groups

Prospective Naloxone cohort

Description:

The prospective cohort consists of study subjects receiving Naloxone nasal spray in the distribution program.

Treatment:

Drug: Naloxone Nasal Spray

Historical control cohort

Description:

Data from the historical control cohort will be collected from national registries years 2013-2017.

Treatment:

Other: Historical control cohort