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临床试验/NCT01457872
NCT01457872已完成不适用

Malmö Treatment Referral and Intervention Study

Region Skane2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
79
试验地点
2
主要终点
Treatment entry in substitution treatment at two time points - directly after referral and after up to 3 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Treatment entry in substitution treatment at two time points - directly after referral and after up to 3 months

时间窗: 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.

次要结局

  • Retention and treatment outcome in substitution treatment(3, 6, 12, 24, 26 months)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (2)

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