Clinical trial NCT01457872: Malmö Treatment Referral and Intervention Study
Official title: Malmö Treatment Referral and Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heroin Addiction
Substance Use Disorders
Keywords: Heroin addiction
Substance use disorders
Substitution treatment
Syringe exchange
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Swedish Council for Working Life and Social Research
First posted: 2011-10-24
Enrollment: 79
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Treatment entry in substitution treatment at two time points - directly after referral and after up to 3 months
timeFrame: At medical examination after 10 days, and subsequently for up to 3 months
Secondary outcomes:
measure: Retention and treatment outcome in substitution treatment
timeFrame: 3, 6, 12, 24, 26 months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Malmö Addiction Centre, Malmö University Hospital entrance 90
Study officials:
References: