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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05678036
Other study ID # Evaluation of OMT choice model
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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