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Effects on Mortality and Clinical Course of a Patient's Choice Model for Opioid Maintenance Treatment for Opioid Dependence - Evaluation of a System Enabling a Large Expansion of Treatment Providers and Treatment Access

Effects on Mortality and Clinical Course of a Patient's Choice Model for Opioid Maintenance Treatment for Opioid Dependence - Evaluation of a System Enabling a Large Expansion of Treatment Providers and Treatment Access

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05678036
Enrollment
2500
Registered
2023-01-10
Start date
2023-01-31
Completion date
2024-07-31
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Dependence, Overdose

Keywords

opioid dependence, opioid maintenance treatment, methadone, buprenorphine

Brief summary

Opioid dependence, for example involving addiction to injected or inhaled heroin or similar compounds, is associated with high mortality, typically from opioid overdose, and causes major physical and mental health complications, social problems and crime. Opioid maintenance treatment (OMT) has proven effective in opioid dependence. In 2014, a patient's choice reform in Skåne county, Sweden, was introduced and led to a vast extension of OMT in the region, including a large number of treatment providers and high access to treatment. Still, opioid-related mortality in the region remains high. While patients' access to treatment has been increased, the content and nature of treatment in the present system has been questioned. The present system, which dramatically altered treatment conditions and access for OMT in this region, has never been formally evaluated in any large-scale study. This study aims to assess clinical course of patients receiving OMT before and during the patient choice reform system, and effects on the extent and nature of opioid-related mortality in the region.

Interventions

DRUGOpioid maintenance treatment

A reform dramatically expanding access to opioid maintenance treatment (with methadone or buprenorphine) in the region.

Sponsors

Lund University
CollaboratorOTHER
Region Skane
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients included in opioid maintenance treatment in Skåne region.

Exclusion criteria

* None.

Design outcomes

Primary

MeasureTime frameDescription
Mortalitystudy inclusion through 2022Mortality and cause of death
Hospitalization for substance use disorder treatmentstudy inclusion through 2022Hospitalization for substance use disorder treatment

Secondary

MeasureTime frameDescription
Mental health disorderstudy inclusion through 2022Occurrence of a mental health disorder diagnosis aparts from opioid dependence in diagnosis and prescription drug registers
Physical disorderstudy inclusion through 2022Occurrence of a physical disorder diagnosis aparts from opioid dependence in diagnosis and prescription drug registers

Countries

Sweden

Contacts

Primary ContactAnders Håkansson, PhD
anders_c.hakansson@med.lu.se+46 46 175596

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026