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临床试验/NCT04585399
NCT04585399已完成不适用

Increasing MAT Engagement With Contingency Management Among Individuals With Opioid Use Disorder in an ED Bridge Program

Rowan University2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2020年1月27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
92
试验地点
2
主要终点
Percentage of sessions where buprenorphine positive urine results was recorded

研究概览

简要总结

The increased prevalence of opioid use disorder (OUD) and associated overdoses and adverse events has led to a substantial increase in the number of patients being seen at emergency departments (ED). Thus, the ED may be an ideal location for identifying patients in need of OUD treatment and can serve as the first touch point in the OUD continuum of care to promote medication assisted treatment initiation. Contingency management (CM) is an effective method for promoting treatment initiation and adherence that has not been thoroughly evaluated for this purpose. The primary aim of the current study is to develop and assess the effectiveness, acceptability, and feasibility of a protocol for delivering CM to increase combined buprenorphine + nalaxone (referred to as BUP hereafter) initiation and continuous adherence for OUD in an existing ED "bridge" program (e.g., Bridge plus CM; B+CM) relative to standard care. Secondary objectives include identifying behavioral and neuropsychological correlates to treatment outcomes, including delay discounting, reinforcer demand, and neurological soft signs.

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
Double (Care Provider, Outcomes Assessor)

盲法说明

Participants will only told if they are assigned to the contingency management group because there are different procedures for those individuals. The care providers will not know which participants are in the control group but they may know when people are in the CM group because extra urine screens will be collected and they will be scheduled for rides.

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

  • Participants at least 18 years of age
  • Participants must be newly enrolled in the Bridge program in the Cooper University ED, with their first clinic appointment scheduled to take place at the Cooper Outreach Clinic within one week of enrollment.
  • All subjects must be in good physical health as determined by a physical examination and premenopausal women will have a pregnancy test on the day of the study to rule out pregnancy

排除标准

  • Participants who demonstrate contraindication with Suboxone treatment or who are currently or have recently used other medication-assisted therapies for opioid use disorder.
  • Participants who are currently pregnant or breastfeeding or have been diagnosed with a DSM-5 psychiatric condition that might interfere with treatment delivery (e.g., uncontrolled schizophrenia, bipolar disorder, dementia)
  • Participants who are non-English speaking or cannot otherwise provide valid informed consent.
  • Individuals who are unable to complete the survey assessments, due to literacy or visual impairments.
  • The participant will not be a prisoner

结局指标

主要结局

Percentage of sessions where buprenorphine positive urine results was recorded

时间窗: 3-months

Urine-verified buprenorphine

Percentage of sessions where opioid free urine results were recorded

时间窗: 3-months

Urine-verified opioid abstinence

Treatment acceptability

时间窗: 3-months

Participants will evaluate the treatment at the end.

Attendance at first scheduled clinic appointment

时间窗: 1 week

We will track attendance at participant's first scheduled BUP appointment after being bridged from the ED

次要结局

  • Opioid demand as a correlate of opioid-free urine test results and buprenorphine-positive results(3-months)
  • Delay discounting as a correlate of opioid-free urine test results and buprenorphine-positive results(3-months)
  • Substance-free activities as a correlate of opioid-free urine test results and buprenorphine-positive results(3-months)
  • Neurological Soft Signs correlate with treatment success(3-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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