Opioid DependenceNCT05678036
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
An observational study of Opioid Dependence and Overdose, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence, Overdose
- What is being tested?
- Opioid maintenance treatment
- How many people
- 2,500 participants
- Where
- 1 siteSweden
- Study dates
- 31 Jan 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included in opioid maintenance treatment in Skåne region since 2014
Who may be able to join
- Patients included in opioid maintenance treatment in Skåne region.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Opioid Dependence, Overdose
- Being tested
- Opioid maintenance treatment
- Keywords
- opioid dependence, opioid maintenance treatment, methadone, buprenorphine
- Medical subject headings
- Opioid-Related Disorders, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid maintenance treatmentDrug
A reform dramatically expanding access to opioid maintenance treatment (with methadone or buprenorphine) in the region.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality and cause of death
Measured: study inclusion through 2022
Hospitalization for substance use disorder treatment
Hospitalization for substance use disorder treatment
Measured: study inclusion through 2022
Secondary outcomes (2)
Mental health disorder
Occurrence of a mental health disorder diagnosis aparts from opioid dependence in diagnosis and prescription drug registers
Measured: study inclusion through 2022
Physical disorder
Occurrence of a physical disorder diagnosis aparts from opioid dependence in diagnosis and prescription drug registers
Measured: study inclusion through 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start31 Jan 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Anders C Håkansson, Region Skane
- Investigators
- Anders Håkansson, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678036
- Sponsor's protocol ID
- Evaluation of OMT choice model
- Status last verified
- Dec 2022
- First submitted
- 28 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05678036
- Acronym / sponsor ID
- Evaluation of OMT choice model
- Conditions
- Opioid Dependence, Overdose
- Keywords
- opioid dependence, opioid maintenance treatment, methadone, buprenorphine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 31 Jan 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in opioid maintenance treatment in Skåne region since 2014
Key inclusion criteria (1 listed)
- Patients included in opioid maintenance treatment in Skåne region.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid maintenance treatmentA reform dramatically expanding access to opioid maintenance treatment (with methadone or buprenorphine) in the region. | Drug | – |
Primary outcome
Mortality
Time frame: study inclusion through 2022
Mortality and cause of death
Hospitalization for substance use disorder treatment
Time frame: study inclusion through 2022
Hospitalization for substance use disorder treatment
2 secondary outcomes
Mental health disorder
Time frame: study inclusion through 2022
Physical disorder
Time frame: study inclusion through 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Håkansson, PhD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Dependence and Overdose, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anders Håkansson, PhD (+46 46 175596, anders_c.hakansson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: study inclusion through 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.