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临床试验/NCT01124591
NCT01124591已完成2 期

Clinical Trial to Determine the Effect of a Brief Behavioral Intervention in Reducing Drug Misuse Among an Emergency Department Population

Rhode Island Hospital2 个研究点 分布在 1 个国家目标入组 1,030 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
1,030
试验地点
2
主要终点
Reduction in behaviors associated with drug misuse

研究概览

简要总结

Although screening, brief intervention, and referral to treatment (SBIRT) approaches are effective in reducing alcohol misuse and its associated risk-taking behaviors and negative consequences, there is little research demonstrating the effectiveness of SBIRT for illicit and/or prescription drug misuse. Misusers of illicit and/or prescription drugs frequently seek medical care in emergency departments (EDs), particularly for reasons related to their misuse. As a result, the ED is well suited as a site to conduct an analysis of the effectiveness of SBIRT for this population.

The Brief Intervention for Drug Misuse for the Emergency Department (BIDMED) study is a randomized, controlled, trial that will include adult ED patients at a large, academic, trauma center (Rhode Island Hospital) and a community hospital (The Miriam Hospital) who have a subcritical illness or injury and whose screening indicates illicit and/or prescription drug misuse. BIDMED participants will be randomized to receive screening only (SO) or brief intervention (BI) with appropriate referral to treatment. Participants will complete a battery of blinded baseline assessments using standardized instruments as well as adapted instruments specific to the aims of this study. All participants will undergo blinded follow-up assessments at three, six, and twelve months post-randomization. The primary hypotheses addressed in the BIDMED study are that, compared to participants in the SO arm, participants in the BI arm will show a significantly greater reduction in: (1) drug misuse within the prior 30 days at three months post-randomization, (2) behaviors associated with drug misuse at six months post-randomization; and (3) negative physical health, psychosocial health, and socioeconomic consequences at twelve months post-randomization. As a secondary aim, the impact of BI compared to SO will be assessed on participants contacting, enrolling in, and completing a drug treatment program. In addition, the impact of BI compared to SO on increasing uptake of HIV and hepatitis B/C screening will be measured. A mechanisms of change model that addresses the expected mediators and moderators of change to explain the effects of SBIRT in this setting will also be developed and tested. Further, the epidemiology of illicit and/or prescription drug misuse will be assessed in a random sample of ED patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Self-report of illicit and/or prescription drug misuse in the past three-months. Presenting at the emergency department for medical care.

排除标准

  • Not age appropriate, in custody, medically unstable, actively psychotic, suicidal

结局指标

主要结局

Reduction in behaviors associated with drug misuse

时间窗: 12 months post-randomization

Reduction in past 30 day drug misuse

时间窗: 12 months post-randomization

Reduction negative physical health, psychosocial health, and socioeconomic consequences

时间窗: 12 months post-randomization

次要结局

  • Uptake of HIV and hepatitis B/C screening(3 months post randomization)

研究者

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

Roland C. Merchant, MD. MPH, ScD

Attending Physician

Rhode Island Hospital

研究点 (2)

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