Malmö Treatment Referral and Intervention Study

Substance Use Disorders Clinical Trial

— MATRIS  

Official title:

Malmö Treatment Referral and Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457872
• Other study ID #: MATRIS
• Status: Completed
• Phase: N/A
• First received: October 18, 2011
• Last updated: November 24, 2014
• Start date: October 2011
• Est. completion date: April 2013

Study information

• Verified date: November 2014
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heroin Addiction
• Heroin Dependence
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Strength-based case management
Strength-based case management
• Control condition - referral only
Referral only

Locations

Country	Name	City	State
Sweden	Malmö Addiction Centre, Malmö University Hospital entrance 90	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Swedish Council for Working Life and Social Research

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At medical examination after 10 days, and subsequently for up to 3 months	No
Secondary	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.	3, 6, 12, 24, 26 months	No