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临床试验/NCT03398265
NCT03398265已完成不适用

Treatment Navigation for Recently Released Prisoners With Opioid Use Disorder

University of Washington5 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2017年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
5
主要终点
Intervention Feasibility

研究概览

简要总结

The investigators will conduct a pilot randomized controlled trial (RCT) study of 100 people with a history of opioid use disorder releasing to WA Department of Corrections (DOC) community corrections supervision in King County. Half of the subjects will receive treatment as usual (e.g. referral to treatment or outpatient drug counseling by DOC community corrections staff) and half will receive 6 months of intervention. The intervention involves treatment decision making, in which the study interventionists help subjects understand treatment choices, decide on the treatment that is best for them, get enrolled in treatment and remain in treatment. The study does not provide treatment, but works with treatment providers to facilitate access to care.

The aims of this study are to determine: 1) whether study procedures can be implemented with as designed, 2) whether offenders can be enrolled and maintained in the study, 3) which medications/treatment options subjects select and their experiences and satisfaction with the interventions, and 4) preliminary intervention effect size on outcomes of interest including recidivism, drug use, hospitalization, and treatment enrollment and retention.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Meets Diagnostic and Statistical Manual (DSM-5) criteria for opioid use disorder (at least 2 criteria) or were receiving treatment for opioid use disorder in the 12 months prior to incarceration.
  • •Released to community corrections, not currently incarcerated.
  • •Able to understand and provide informed consent.
  • •Has access to phone (voice or text) or email to communicate with research staff.

排除标准

  • •Under age 18 or over age 70 at time of recruitment.
  • •Currently enrolled in an opioid treatment program using medications.
  • •Has not used opioids (prescription type or heroin) in the past 6 months prior to incarceration.
  • •Unwilling to allow access to medical or drug treatment records, criminal history or criminal activity records.
  • •Inability to communicate in English verbally.
  • •Inability to provide adequate contact information to assist with follow-up.
  • •Not planning on being in King County or reporting to community corrections in King County for 6 months.
  • •Violent or overtly hostile/threatening towards research staff.
  • •Entering a controlled environment for 31 days or more in the next 6 months.

研究组 & 干预措施

Intervention

Experimental

Initial discussion regarding opioid treatment options followed by 6 months of treatment navigation.

干预措施: Treatment Navigation (Intervention) (Behavioral)

Control

Other

Referrals to treatment from corrections staff.

干预措施: Control (Other)

结局指标

主要结局

Intervention Feasibility

时间窗: 6 months

The number of potentially eligible subjects self-referred or identified by Department of Corrections whom study staff were able to contact, screen, determine to be eligible and enroll in the study at Community Corrections facilities.

次要结局

  • Criminal Activity(6 months)
  • Relapse Prevention Medication Prescriptions(6 months)
  • Hospitalizations(6 months)
  • Treatment Enrollment(6 months)
  • Criminal Activity(1 month)
  • Hospitalizations(1 month)
  • Treatment Enrollment(1 month)
  • Relapse Prevention Medication Prescriptions(1 month)

研究者

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

Caleb Banta-Green

Principal Research Scientist, Alcohol and Drug Abuse Institute

University of Washington

研究点 (5)

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