Trial record 10 of 15 for:    Open Studies | "Heroin Dependence"

Malmö Treatment Referral and Intervention Study (MATRIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Region Skane
Sponsor:
Collaborator:
Swedish Council for Working Life and Social Research
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01457872
First received: October 18, 2011
Last updated: October 12, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457872

Contacts
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

Locations
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         
Sponsors and Collaborators
Region Skane
Swedish Council for Working Life and Social Research
  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 July 22, 2014