NCT01457872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

1.5 years

First QC Date

October 18, 2011

Last Update Submit

November 24, 2014

Conditions

Keywords

Heroin addictionSubstance use disordersSubstitution treatmentSyringe exchange

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Retention and treatment outcome in substitution treatment

    3, 6, 12, 24, 26 months

Study Arms (2)

Strength-based case management

EXPERIMENTAL

Case management plus referral (vs referral-only)

Behavioral: Strength-based case management

Referral only

ACTIVE COMPARATOR

Referral only (no case management intervention)

Behavioral: Control condition - referral only

Interventions

Strength-based case management

Strength-based case management

Referral only

Referral only

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Registered at syringe exchange programme of Malmö
  • Primary drug heroin
  • Heroin dependence
  • Living in catchment area for substitution treatment of Addiction Centre Malmö

You may not qualify if:

  • Inability to understand consent and information
  • Unstable psychiatric condition making treatment regulations impossible
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malmö Addiction Centre, Malmö University Hospital entrance 90

Malmo, 205 02, Sweden

Location

MeSH Terms

Conditions

Heroin DependenceSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Opioid-Related DisordersNarcotic-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 24, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations