Malmö Treatment Referral and Intervention Study (MATRIS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heroin Addiction Substance Use Disorders |
Behavioral: Strength-based case management Behavioral: Control condition - referral only |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Malmö Treatment Referral and Intervention Study |
- 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 ] [ Designated as safety issue: No ]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.
- Retention and treatment outcome in substitution treatment [ Time Frame: 3, 6, 12, 24, 26 months ] [ Designated as safety issue: No ]Percentage of patients remaining in treatment. Treatment outcome including decrease in substance use and improvement in clinical picture.
| Estimated Enrollment: | 130 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Strength-based case management
Case management plus referral (vs referral-only)
|
Behavioral: Strength-based case management
Strength-based case management
|
|
Active Comparator: Referral only
Referral only (no case management intervention)
|
Behavioral: Control condition - referral only
Referral only
|
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Registered at syringe exchange programme of Malmö
- Primary drug heroin
- Heroin dependence
- Living in catchment area for substitution treatment of Addiction Centre Malmö
Exclusion Criteria:
- Inability to understand consent and information
- Unstable psychiatric condition making treatment regulations impossible
- Pregnancy
Contacts and Locations| Contact: Anders Håkansson, MD, PhD | +46 703 135677 | anders_c.hakansson@med.lu.se |
| Contact: Martin Bråbäck, MD | +46 40 331600 | martin.braback@med.lu.se |
| Sweden | |
| Malmö Addiction Centre, Malmö University Hospital entrance 90 | Recruiting |
| Malmö, Sweden, 205 02 | |
| Contact: Anders Håkansson, MD, PhD + 46 703 135677 anders_c.hakansson@med.lu.se | |
| Contact: Martin Bråbäck, MD +46 40 331600 martin.braback@med.lu.se | |
| Principal Investigator: Anders Håkansson, MD, PhD | |
More Information
No publications provided
| Responsible Party: | Region Skane |
| ClinicalTrials.gov Identifier: | NCT01457872 History of Changes |
| Other Study ID Numbers: | MATRIS |
| Study First Received: | October 18, 2011 |
| Last Updated: | October 12, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Region Skane:
|
Heroin addiction Substance use disorders Substitution treatment Syringe exchange |
Additional relevant MeSH terms:
|
Heroin Dependence Substance-Related Disorders Behavior, Addictive Opioid-Related Disorders |
Mental Disorders Compulsive Behavior Impulsive Behavior |
ClinicalTrials.gov processed this record on May 16, 2013