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

NCT ID: NCT05678036

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-31

Study Completion Date

2024-07-31

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.

Detailed Description

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Conditions

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Opioid Dependence Overdose

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Interventions

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Opioid maintenance treatment

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients included in opioid maintenance treatment in Skåne region.

Exclusion Criteria

* None.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Anders C Håkansson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Håkansson, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skåne

Locations

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Malmö Addiction Center

Malmo, , Sweden

Site Status

Countries

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Sweden

Central Contacts

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Anders Håkansson, PhD

Role: CONTACT

+46 46 175596

Other Identifiers

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Evaluation of OMT choice model

Identifier Type: -

Identifier Source: org_study_id

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