Heroin AddictionMATRISNCT01457872
Malmö Treatment Referral and Intervention Study
A study testing Strength-based case management in people with Heroin Addiction and Substance Use Disorders, run by Region Skane at 1 site in Sweden.
Trial summary
This study aims to study and implement active referral of heroin users from a syringe exchange programme to evidence-based treatment for heroin addiction. Patients are randomized to either a strength-based case management intervention or a control group, while both groups receive referral to medical investigation for… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heroin Addiction, Substance Use Disorders
- What is being tested?
- Strength-based case management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to Apr 2013
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Registered at syringe exchange programme of Malmö
- Primary drug heroin
- Heroin dependence
- Living in catchment area for substitution treatment of Addiction Centre Malmö
Who cannot join
- Inability to understand consent and information
- Unstable psychiatric condition making treatment regulations impossible
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Malmö Addiction Centre, Malmö University Hospital entrance 90
Malmö, 205 02
About this study
This study aims to study and implement active referral of heroin users from a syringe exchange programme to evidence-based treatment for heroin addiction. Patients are randomized to either a strength-based case management intervention or a control group, while both groups receive referral to medical investigation for inclusion in substitution treatment for heroin addiction. The hypothesis is that syringe exchange can be used for referral to effective treatment, and that a strength-based intervention can increase the number of patients who are successfully referred and enter treatment.
Read the detailed description
Patients attending the syringe exchange programme of Malmö, Sweden, and who are using heroin as their primary drug of abuse and who live in the catchment area of Malmö Addiction Centre, will be addressed, and patients willing to participate will undergo a baseline interview and will be referred to medical examination for decision to start substitution treatment to treat heroin dependence. Half of patients will be randomized to a strength-based case management intervention, hypothesized to facilitate treatment entry, and half of patients will be randomized to a control condition involving only referral.
The study will measure the number of patients who successfully accept referral and initiate substitution treatment for heroin dependence, comparing patients in intervention arm to patients in the control condition (RCT design). Also, as a secondary outcome measure, retention and treatment outcome (substance use and clinical characteristics) will be compared between the two groups. In addition, this study will enable a number of sub-analyses aiming to increase knowledge about heroin addicts' detailed substance use pattern and clinical characteristics. Patients will be followed with respect to retention, substance use and clinical picture for three years.
- Conditions
- Heroin Addiction, Substance Use Disorders
- Being tested
- Strength-based case management, Control condition - referral only
- Keywords
- Heroin addiction, Substance use disorders, Substitution treatment, Syringe exchange
- Medical subject headings
- Heroin Dependence, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength-based case managementBehavioural
Strength-based case management
Control condition - referral onlyBehavioural
Referral only
| Study group | Role | What they receive |
|---|---|---|
| Strength-based case management | Experimental | Case management plus referral (vs referral-only) Receives: Behavioral: Strength-based case management |
| Referral only | Active comparator | Referral only (no case management intervention) Receives: Behavioral: Control condition - referral only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment entry in substitution treatment at two time points - directly after referral and after up to 3 months
Percentage of patients successfully referred for examination and start of substitution treatment. This is measured at two time points, at 10 days post-referral when the medical examination is carried out (the percentage of patients who successfully show up) and subsequently the patients will be followed up to three months post-referral with respect to actual initiation of medication.
Measured: At medical examination after 10 days, and subsequently for up to 3 months
Secondary outcomes (1)
Retention and treatment outcome in substitution treatment
Percentage of patients remaining in treatment. Treatment outcome including decrease in substance use and improvement in clinical picture.
Measured: 3, 6, 12, 24, 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin AddictionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457872
- Sponsor's protocol ID
- MATRIS
- Acronym
- MATRIS
- Status last verified
- Nov 2014
- First submitted
- 18 Oct 2011
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malmö Treatment Referral and Intervention Study
- ClinicalTrials.gov ID
- NCT01457872
- Acronym / sponsor ID
- MATRIS / MATRIS
- Conditions
- Heroin Addiction, Substance Use Disorders
- Keywords
- Heroin addiction, Substance use disorders, Substitution treatment, Syringe exchange
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Oct 2011 (estimated)
- 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.
This study aims to study and implement active referral of heroin users from a syringe exchange programme to evidence-based treatment for heroin addiction. Patients are randomized to either a strength-based case management intervention or a control group, while both groups receive referral to medical investigation for inclusion in substitution treatment for heroin addiction. The hypothesis is that syringe exchange can be used for referral to effective treatment, and that a strength-based intervention can increase the number of patients who are successfully referred and enter treatment.
Detailed description
Patients attending the syringe exchange programme of Malmö, Sweden, and who are using heroin as their primary drug of abuse and who live in the catchment area of Malmö Addiction Centre, will be addressed, and patients willing to participate will undergo a baseline interview and will be referred to medical examination for decision to start substitution treatment to treat heroin dependence. Half of patients will be randomized to a strength-based case management intervention, hypothesized to facilitate treatment entry, and half of patients will be randomized to a control condition involving only referral.
The study will measure the number of patients who successfully accept referral and initiate substitution treatment for heroin dependence, comparing patients in intervention arm to patients in the control condition (RCT design). Also, as a secondary outcome measure, retention and treatment outcome (substance use and clinical characteristics) will be compared between the two groups. In addition, this study will enable a number of sub-analyses aiming to increase knowledge about heroin addicts' detailed substance use pattern and clinical characteristics. Patients will be followed with respect to retention, substance use and clinical picture for three years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength-based case management | Experimental | Behavioral: Strength-based case managementCase management plus referral (vs referral-only) |
| Referral only | Active comparator | Behavioral: Control condition - referral onlyReferral only (no case management intervention) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Registered at syringe exchange programme of Malmö
- Primary drug heroin
- Heroin dependence
- Living in catchment area for substitution treatment of Addiction Centre Malmö
Key exclusion criteria (3 listed)
- Inability to understand consent and information
- Unstable psychiatric condition making treatment regulations impossible
- Pregnancy
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 |
|---|---|---|
| Strength-based case managementStrength-based case management | Behavioural | Strength-based case management |
| Control condition - referral onlyReferral only | Behavioural | Referral only |
Primary outcome
Treatment entry in substitution treatment at two time points - directly after referral and after up to 3 months
Time frame: At medical examination after 10 days, and subsequently for up to 3 months
Percentage of patients successfully referred for examination and start of substitution treatment. This is measured at two time points, at 10 days post-referral when the medical examination is carried out (the percentage of patients who successfully show up) and subsequently the patients will be followed up to three months post-referral with respect to actual initiation of medication.
1 secondary outcome
Retention and treatment outcome in substitution treatment
Time frame: 3, 6, 12, 24, 26 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength-based case management in people with Heroin Addiction and Substance Use Disorders, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 25 Nov 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment entry in substitution treatment at two time points - directly after referral and after up to 3 months (time frame: At medical examination after 10 days, and subsequently for up to 3 months). 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 25 Nov 2014.