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

Not yet recruiting

• Conditions: Opioid Dependence; Overdose

• Registration Number: NCT05678036
• Lead Sponsor: Region Skane

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-28
• Study First Submitted QC: 2022-12-28
• Last Update Submitted: 2022-12-28
• Study First Posted: 2023-01-10
• Last Update Posted: 2023-01-10
• Study Start: 2023-01-31
• Primary Completion: 2023-09-30
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• Patients included in opioid maintenance treatment in Skåne region.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	study inclusion through 2022	Mortality and cause of death
Hospitalization for substance use disorder treatment	study inclusion through 2022	Hospitalization for substance use disorder treatment

Secondary Outcome Measures

Name	Time	Method
Mental health disorder	study inclusion through 2022	Occurrence of a mental health disorder diagnosis aparts from opioid dependence in diagnosis and prescription drug registers
Physical disorder	study inclusion through 2022	Occurrence of a physical disorder diagnosis aparts from opioid dependence in diagnosis and prescription drug registers

Trial Locations

Locations (1)

Malmö Addiction Center; 🇸🇪 Malmö, Sweden