Malmö Treatment Referral and Intervention Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Malmö Treatment Referral and Intervention Study

Conditions
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Heroin Addiction, Substance Use Disorders

Intervention / Treatment
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* Behavioral: Strength-based case management
* Behavioral: Control condition - referral only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength-based case management<br>Case management plus referral (vs referral-only) | Behavioral: Strength-based case management<br>* Strength-based case management<br>|
| Active Comparator: Referral only<br>Referral only (no case management intervention) | Behavioral: Control condition - referral only<br>* Referral only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heroin addiction, Substance use disorders, Substitution treatment, Syringe exchange