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Malmö Treatment Referral and Intervention Study

NCT ID: NCT01457872

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-04-30

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.

Conditions

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Heroin Addiction Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Strength-based case management

Case management plus referral (vs referral-only)

Group Type EXPERIMENTAL

Strength-based case management

Intervention Type BEHAVIORAL

Strength-based case management

Referral only

Referral only (no case management intervention)

Group Type ACTIVE_COMPARATOR

Control condition - referral only

Intervention Type BEHAVIORAL

Referral only

Interventions

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Strength-based case management

Strength-based case management

Intervention Type BEHAVIORAL

Control condition - referral only

Referral only

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Council for Working Life and Social Research

OTHER

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Malmö Addiction Centre, Malmö University Hospital entrance 90

Malmo, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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MATRIS

Identifier Type: -

Identifier Source: org_study_id