Malmö Treatment Referral and Intervention Study (MATRIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01457872
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : November 25, 2014
Swedish Council for Working Life and Social Research
Information provided by (Responsible Party):
Region Skane

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.

Condition or disease Intervention/treatment Phase
Heroin Addiction Substance Use Disorders Behavioral: Strength-based case management Behavioral: Control condition - referral only Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Malmö Treatment Referral and Intervention Study
Study Start Date : October 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Retention and treatment outcome in substitution treatment [ Time Frame: 3, 6, 12, 24, 26 months ]
    Percentage of patients remaining in treatment. Treatment outcome including decrease in substance use and improvement in clinical picture.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01457872

Malmö Addiction Centre, Malmö University Hospital entrance 90
Malmö, Sweden, 205 02
Sponsors and Collaborators
Region Skane
Swedish Council for Working Life and Social Research

Responsible Party: Region Skane Identifier: NCT01457872     History of Changes
Other Study ID Numbers: MATRIS
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014

Keywords provided by Region Skane:
Heroin addiction
Substance use disorders
Substitution treatment
Syringe exchange

Additional relevant MeSH terms:
Behavior, Addictive
Substance-Related Disorders
Heroin Dependence
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders
Opioid-Related Disorders