Malmö Treatment Referral and Intervention Study (MATRIS)
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|ClinicalTrials.gov Identifier: NCT01457872|
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : November 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Heroin Addiction Substance Use Disorders||Behavioral: Strength-based case management Behavioral: Control condition - referral only||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01457872
|Malmö Addiction Centre, Malmö University Hospital entrance 90|
|Malmö, Sweden, 205 02|