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临床试验/NCT00317460
NCT00317460已完成4 期

On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings

Yale University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
52
试验地点
2
主要终点
Treatment retention

研究概览

简要总结

The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting.

详细描述

The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting. The proposed study will compare Physician Management (PM), a manual-guided brief intervention that approximates the usual counseling provided by primary care practitioners to patients with chronic medical conditions vs. an enhanced strategy of PM with the addition of a combined drug counseling and adherence management strategy (PM+DC/AM). DC is designed to educate the patient about the recovery process and provide additional advice about lifestyle changes including HIV transmission risk reduction and 12-step participation. Adherence Management (AM) is a counseling strategy focusing on HIV medication adherence, adapted from Sorensen et al1. This research will build on pilot work that is being completed in order to further develop and refine these counseling interventions, determine what other psychosocial interventions might be required, and to evaluate this model of integrated care in terms of its effects on opioid agonist therapy retention, decreasing illicit drug use, and increasing adherence to highly active antiretroviral therapy (HAART). Finally, it will provide data that will aid in the formulation of guidelines and the creation of practical manuals for optimizing the provision of this novel therapy to individuals with HIV disease and opioid dependence, as well as provide data for future funded randomized clinical trials.

From September 2005 (start date) to December 1, 2007, the study was conducted as part of a multi-site project that was overseen by the New York Academy of Medicine (NYAM), which is in charge of data analysis. Following December 1, 2007, the study will continue as a local, single-site project without further collaboration from NYAM.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV disease
  • DSM-IV criteria for opioid dependence, as assessed by SCID
  • Documented opioid positive urine toxicology testing
  • Exclusion criteria:
  • Desire to remain enrolled in opioid agonist treatment at an opioid treatment program
  • Current dependence on alcohol, benzodiazepines or sedatives (patients who are receiving benzodiazepines under the care of a psychiatrist for the treatment of an anxiety disorder will not be excluded)
  • Current suicide or homicide risk
  • Current psychotic disorder or major depression
  • Inability to read or understand English
  • Life-threatening or unstable medical problems requiring inpatient medical care or nursing home placement
  • Currently enrolled in other studies involving the provision of psychosocial treatment.

排除标准

  • 未提供

结局指标

主要结局

Treatment retention

时间窗: 52 weeks

Reductions in illicit opioid use

时间窗: 52 weeks

Adherence to antiretroviral medications

时间窗: 52 weeks

次要结局

  • HIV-1 RNA levels(52 weeks)
  • T-lymphocyte CD4 cell count(52 weeks)
  • Improved health status(52 weeks)
  • Provider satisfaction(52 weeks)
  • Reduction in HIV transmission risk behaviors(52 weeks)
  • Patient satisfaction(52 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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