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

Opioid Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05678036
• Other study ID #: Evaluation of OMT choice model
• Status: Not yet recruiting
• Start date: January 31, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2022
• Source: Region Skane
• Contact: Anders Håkansson, PhD
• Phone: +46 46 175596
• Email: anders_c.hakansson[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: July 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients included in opioid maintenance treatment in Skåne region.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders
• Overdose

Intervention

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

Locations

Country	Name	City	State
Sweden	Malmö Addiction Center	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality and cause of death	study inclusion through 2022
Primary	Hospitalization for substance use disorder treatment	Hospitalization for substance use disorder treatment	study inclusion through 2022
Secondary	Mental health disorder	Occurrence of a mental health disorder diagnosis aparts from opioid dependence in diagnosis and prescription drug registers	study inclusion through 2022
Secondary	Physical disorder	Occurrence of a physical disorder diagnosis aparts from opioid dependence in diagnosis and prescription drug registers	study inclusion through 2022