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临床试验/NCT04372238
NCT04372238已完成不适用

The Rhode Island Prescription and Illicit Drug Study Responding to Fentanyl and Associated Harms

Brown University2 个研究点 分布在 1 个国家目标入组 509 人开始时间: 2020年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
509
试验地点
2
主要终点
Number of People Identified Has Having One or More Overdose Among RAPIDS Trial Participants

研究概览

简要总结

This study will test the efficacy of a novel drug-checking intervention to prevent fatal and non-fatal overdose among people who use drugs (PWUD), who are 18-65 years old at the time of enrollment. The investigators will evaluate whether the incorporation of rapid fentanyl testing into a theory-driven overdose education and prevention intervention reduces rates of overdose compared to standard overdose education and naloxone distribution. Results from this study will significantly improve public health efforts to address the fentanyl overdose epidemic and reduce harms associated with exposure to drugs contaminated with fentanyl. This is a full clinical trial, building on the previously approved fentanyl-test-strip pilot study (2016-2017), the results of which have recently been published.(Krieger et al., 2018)

详细描述

The investigators will assess the efficacy of the RAPIDS intervention on preventing overdose among PWUD. Participants will be randomized 1:1 to receive the RAPIDS intervention or the attention-matched control condition. Experimental arm participants will receive the RAPIDS intervention, which includes education about the dangers of illicitly manufactured fentanyl (IMF), motivational interviewing to increase willingness to use fentanyl test strips and engage in overdose risk reduction behaviors, hands-on training to use the test strips, and opportunities to plan and role- play how to implement overdose risk reduction behaviors upon receipt of a positive or negative test result. In the attention-matched control arm, participants will receive standardized overdose education and naloxone distribution (OEND) training. All participants will attend additional study visits at months 1,2,3,6, and 12. The primary endpoint will be the rate of self-reported overdose over the follow-up period. Secondary endpoints (e.g., overdose death) will be ascertained by data linkage to statewide overdose surveillance databases.

The primary aims of this study are to: 1) Assess the efficacy of the RAPIDS intervention in reducing rates of overdose among people who use drugs; 2) Examine the degree to which reductions in rates of overdose are mediated by increases in information, motivation, behavioral skills, and self-efficacy regarding fentanyl, rapid fentanyl testing, and harm reduction practices; and 3) Explore whether there is heterogeneity of treatment effect related to key participant characteristics.

研究设计

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

盲法说明

The biostatistician will be blinded to the intervention/control group assignment throughout the course of the study and the assignments.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Reside in Rhode Island
  • Are able to complete interviews in English
  • Are able to provide informed consent
  • Self-report past 30 day heroin, illicit stimulants, counterfeit prescription pills, or injection drugs

排除标准

  • Participants who exclusively misuse medications obtained from a physician or diversion from someone else's prescription

结局指标

主要结局

Number of People Identified Has Having One or More Overdose Among RAPIDS Trial Participants

时间窗: 12 months post-randomization

A composite measure was created in order to be able to create a count of overdoses experienced at 6 or 12 months post baseline. This was from a combination of sefl-reported data, and administrative data.

Accidental Non-fatal Overdose in the Past Month

时间窗: 12 months post-randomization

At each visit, we asked participants a yes or no question as to whether they experienced an overdose in the last month. This self-reported outcome was creating by taking the number of people who reported an overdose at a given time increment and dividing it by the total number of visits completed at that time increment. We did this for each arm. So for example, at month 1, the calculation would have been \[number of intervention participants reporting an overdose at baseline\]/\[total visits completed by intervention participants at month 1\]

次要结局

  • The Number of Fatal Overdose Events(12 months post-randomization)
  • Number of Participants With Positive Dry Blood Spot Samples(12 months post randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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