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Malmö Treatment Referral and Intervention Study (MATRIS)

Primary Purpose

Heroin Addiction, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Strength-based case management
Control condition - referral only
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heroin Addiction focused on measuring Heroin addiction, Substance use disorders, Substitution treatment, Syringe exchange

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Malmö Addiction Centre, Malmö University Hospital entrance 90

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Strength-based case management

Referral only

Arm Description

Case management plus referral (vs referral-only)

Referral only (no case management intervention)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 18, 2011
Last Updated
November 24, 2014
Sponsor
Region Skane
Collaborators
Swedish Council for Working Life and Social Research
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1. Study Identification

Unique Protocol Identification Number
NCT01457872
Brief Title
Malmö Treatment Referral and Intervention Study
Acronym
MATRIS
Official Title
Malmö Treatment Referral and Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Swedish Council for Working Life and Social Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Addiction, Substance Use Disorders
Keywords
Heroin addiction, Substance use disorders, Substitution treatment, Syringe exchange

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strength-based case management
Arm Type
Experimental
Arm Description
Case management plus referral (vs referral-only)
Arm Title
Referral only
Arm Type
Active Comparator
Arm Description
Referral only (no case management intervention)
Intervention Type
Behavioral
Intervention Name(s)
Strength-based case management
Intervention Description
Strength-based case management
Intervention Type
Behavioral
Intervention Name(s)
Control condition - referral only
Intervention Description
Referral only
Primary Outcome Measure Information:
Title
Treatment entry in substitution treatment at two time points - directly after referral and after up to 3 months
Description
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.
Time Frame
At medical examination after 10 days, and subsequently for up to 3 months
Secondary Outcome Measure Information:
Title
Retention and treatment outcome in substitution treatment
Description
Percentage of patients remaining in treatment. Treatment outcome including decrease in substance use and improvement in clinical picture.
Time Frame
3, 6, 12, 24, 26 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Malmö Addiction Centre, Malmö University Hospital entrance 90
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden

12. IPD Sharing Statement

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Malmö Treatment Referral and Intervention Study

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