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临床试验/NCT01751789
NCT01751789已完成不适用

Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care

Butler Hospital2 个研究点 分布在 1 个国家目标入组 335 人开始时间: 2012年10月最近更新:
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
335
试验地点
2
主要终点
Illicit opioid use

研究概览

简要总结

The purpose of this study is to determine whether, for individuals in inpatient opioid detoxification, linking to outpatient Suboxone treatment increases treatment adherence and reduces relapse to illicit opioid use.

详细描述

In this randomized trial, consenting individuals seeking inpatient opioid detoxification will be assigned to one of two groups. The first group will receive a tapering schedule of buprenorphine during inpatient detoxification to alleviate acute withdrawal symptoms, and referral to a community medical and substance abuse treatment providers (DETOX). The second group will also receive buprenorphine to relieve withdrawal symptoms, but will maintain a stable dose of buprenorphine through inpatient discharge and linkage to an appointment with a primary care provider within a week of discharge (LINKAGE). All participants complete study assessments at baseline, 1-month, 3-months and 6-months post-enrollment.

The SSTAR inpatient detoxification program based in Fall River, Massachusetts will serve as the recruitment site of this trial. SSTAR's program has 38 beds and is a 24-hour medically and psychiatrically supervised treatment facility that provides evaluation and withdrawal management. The SSTAR Family Healthcare Center is a 330 Federally Qualified facility also in Fall River that provides primary care and behavioral health services to residents of Community Health Network Area 25 (Fall River, Somerset, Swansea and Westport, Massachusetts). Dr. Bailey, Director of Research at SSTAR, will oversee the provision of buprenorphine treatment to study participants during detoxification and serve as liaison to the primary care providers at the Family Healthcare Center.

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

入选标准

  • 18 years of age or older;
  • opioid dependent;
  • interested in initiating maintenance buprenorphine treatment;
  • opioid positive on urine toxicology;
  • willing to establish primary care with a buprenorphine-waivered physician at SSTAR.

排除标准

  • Patients unable to provide informed consent due to acute illness, cognitive impairment, or psychosis;
  • probation/parole requirements that might interfere with protocol participation (1% of SSTAR inpatients);
  • inability to provide two contact persons to verify location;
  • not able to complete assessments in English;
  • currently enrolled in a methadone or suboxone maintenance program;
  • plans to leave the area within the next 6 months;
  • current DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, cocaine, or alcohol;
  • current suicidality on the Modified Scale for Suicidal Ideation;
  • chronic pain requiring ongoing opioid use or anticipated major painful event (significant surgical procedure) in the coming 6 months;
  • pregnancy;
  • history of allergic reaction to buprenorphine or naloxone.

研究组 & 干预措施

Linkage

Active Comparator

Participants will receive Suboxone during their inpatient detoxication and be given outpatient appointments to continue Suboxone treatment after completing inpatient detoxification

干预措施: Linkage (Behavioral)

Detoxification

Placebo Comparator

Participants will receive Suboxone to detoxify from opioids and the standard treatment offered by the inpatient detoxification program

干预措施: Treatment as Usual (Other)

结局指标

主要结局

Illicit opioid use

时间窗: 6 months

Illicit opioid use will be measured by self-report and by urine toxicology

Health Service Utilization

时间窗: 6 months

Health service utilization will be measured by self-report and medical chart review

次要结局

未报告次要终点

研究者

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

Michael Stein, MD

Principal Investigator

Butler Hospital

研究点 (2)

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