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临床试验/NCT01822327
NCT01822327Unknown2 期

Treating Cocaine Abuse: A Behavioral Approach

University of Vermont2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
2 期
入组人数
124
试验地点
2
主要终点
Biochemically-Verified Cocaine Use

研究概览

简要总结

This study is designed to advance our development of a treatment for cocaine dependence. The investigators hypothesize that clients with high-risk characteristics will benefit from enhanced levels of treatment.

详细描述

Treatment development for cocaine dependence often proceeds without effort to adapt treatment parameters to patient characteristics. Such a one-size-fits-all approach is problematic because of the heterogeneity of the clinical population. Additionally, the approach is often subject to opposing biases either towards constraining costs or maximizing efficacy. This project includes two sequential clinical trails examining variations of the CRA + Vouchers treatment for cocaine dependence that are designed to explore matching treatment parameters to patient baseline characteristics known to moderate treatment response among cocaine-dependent outpatients. In Trial 1, all patients were randomly assigned to receive 24 weeks of CRA therapy but randomly assigned to one of three voucher-based incentive conditions: (a) 6 weeks of vouchers contingent on abstinence and incentive monetary value at usual level; (b) 6 weeks of vouchers contingent on abstinence but incentive value set at usual level for low-severity patients (intranasal cocaine users or married patients) and at twice the usual value for high severity patients (i.e., unmarried cocaine smokers/injectors), or to (c) a control condition where incentives were provided independent of recent cocaine use. In Trial 2, all patients receive 12 weeks of abstinence-contingent incentives, but randomly assigned to also receive (a) 24 weeks of CRA therapy or (b) 4 weeks of CRA therapy. The overarching goal of the two trials is to strike a balance between the aforementioned biases towards constraining costs or maximizing efficacy and thereby facilitate cost containment without compromising efficacy, especially among more severe patients.

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

入选标准

  • 18 years and older
  • Meets DSM IV criteria for cocaine dependence

排除标准

  • Psychosis
  • Pregnancy
  • Leaving immediate geographic area sooner than 6 months
  • An organic psychiatric disorder
  • Medical illness such that participation is not feasible (e.g., on dialysis).
  • Subjects in acute alcohol withdrawal
  • Uncontrolled seizure disorder
  • Significant depression or suicidal ideation (pending psychological evaluation)

结局指标

主要结局

Biochemically-Verified Cocaine Use

时间窗: 2 years

次要结局

  • Addiction Severity Inventory Scores(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen T. Higgins

Professor of Psychiatry and Psychology

University of Vermont

研究点 (2)

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