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临床试验/NCT03345394
NCT03345394已完成不适用

Effectiveness of Contingency Management in the Treatment of Crack Addiction for Individuals Living in the "Crackland" Region. A Single-blind Randomized Controlled Trial

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
98
试验地点
2
主要终点
Pattern of Crack Cocaine Use

研究概览

简要总结

Crack addiction has become a severe public health problem in Brazil. Crack users present elevated prevalence rates of psychiatric comorbidities, sexual transmitted infections and unemployment with high probability of living or have lived in the streets, history of incarceration and engagement in illegal activities. For the last 20 years a treatment called Contingency Management (CM) have achieved the best results regarding reduction of substance use, promotion of abstinence, treatment attendance and retention in treatment. The first CM study conducted in Brazil advocates for the efficacy of CM on all of these outcomes, suggesting that CM can be effective in a Brazilian population of crack users.

详细描述

The objective of this study is to evaluate the effectiveness of Contingency Management (CM) for crack users living in the "Crackland" region. To achieve this goal, regular treatment staff from Unidade Recomeço Helvétia treatment service will be capacitated in CM to latter-on apply the CM intervention in their respective services. The design will be a single-blind randomized clinical trial composed of a sample of 100 subjects with current diagnose for crack/cocaine dependence. Participants allocated to the control condition will receive 12 weeks of the usual care treatment provided by these two treatment facilities. Participants allocated to the experimental condition will receive the exact same treatment as control participants associated with CM. CM procedure will occur 2 timer per week (every Monday and Thursday or Tuesday and Friday). Primary outcomes are: (1)retention in treatment; (2) reduction of crack use; (3) promotion of continuous crack cocaine abstinence. Secondary findings are reduction on psychiatric symptomatology. The investigator hypothesis is that participants in the CM condition will have a better treatment response in all studied outcomes.

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
Single (Investigator)

盲法说明

researchers had no contact with participants during the 12 week trial

入排标准

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

入选标准

  • DSM-V diagnose for crack cocaine use disorder

排除标准

  • being under 18 years old

结局指标

主要结局

Pattern of Crack Cocaine Use

时间窗: 12 weeks

Percentage of negative crack cocaine urine samples submitted during the 12 weeks of treatment

Promotion of Continuous Crack Cocaine Abstinence

时间窗: 12 weeks

Longest duration of continuous abstinence achieved (in weeks)

次要结局

  • Treatment Retention(12 weeks)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

André de Queiroz Constantino Miguel

Principal Investigator

Federal University of São Paulo

研究点 (2)

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