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

• Sponsor: Region Skane (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05678036
• Collaborator: Lund University (Other)
• Enrollment: 2,500
• Location: 1
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 139.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Dependence; Overdose	Drug: Opioid maintenance treatment

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2500 participants
• Observational Model: Ecologic or Community
• Time Perspective: Retrospective
• 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
• Anticipated Study Start Date: Jan 31, 2023
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Jul 31, 2024

Outcome Measures

Primary Outcome Measures

1. Mortality [study inclusion through 2022]

   Mortality and cause of death

2. Hospitalization for substance use disorder treatment [study inclusion through 2022]

   Hospitalization for substance use disorder treatment

Secondary Outcome Measures

1. Mental health disorder [study inclusion through 2022]

   Occurrence of a mental health disorder diagnosis aparts from opioid dependence in diagnosis and prescription drug registers

2. Physical disorder [study inclusion through 2022]

   Occurrence of a physical disorder diagnosis aparts from opioid dependence in diagnosis and prescription drug registers

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients included in opioid maintenance treatment in Skåne region.

Exclusion Criteria:

• None.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Malmö Addiction Center	Malmö		Sweden

Sponsors and Collaborators

• Region Skane
• Lund University

Investigators

• Principal Investigator: Anders Håkansson, PhD, Region Skåne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anders C Håkansson, Professor, Region Skane
• ClinicalTrials.gov Identifier: NCT05678036
• Other Study ID Numbers: Evaluation of OMT choice model
• First Posted: Jan 10, 2023
• Last Update Posted: Jan 10, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Anders C Håkansson, Professor, Region Skane: opioid dependence; opioid maintenance treatment; methadone; buprenorphine
• Additional relevant MeSH terms: Opioid-Related Disorders; Analgesics, Opioid

Study Results

No Results Posted as of Jan 10, 2023