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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Opioid Dependence, Overdose

Intervention / Treatment
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* Drug: Opioid maintenance treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients included in opioid maintenance treatment in Skåne region. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Opioid maintenance treatment|A reform dramatically expanding access to opioid maintenance treatment (with methadone or buprenorphine) in the region.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality and cause of death | study inclusion through 2022 | 
| Hospitalization for substance use disorder treatment | Hospitalization for substance use disorder treatment | study inclusion through 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental health disorder | Occurrence of a mental health disorder diagnosis aparts from opioid dependence in diagnosis and prescription drug registers | study inclusion through 2022 | 
| Physical disorder | Occurrence of a physical disorder diagnosis aparts from opioid dependence in diagnosis and prescription drug registers | study inclusion through 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid dependence, opioid maintenance treatment, methadone, buprenorphine