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临床试验/NCT00182598
NCT00182598Unknown不适用

Applying Web Technology to Buprenorphine Treatment

National Development and Research Institutes, Inc.2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2004年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
opiate use

研究概览

简要总结

The purpose of this clinical trial is to examine the efficacy and cost-effectiveness of an interactive, computer-based psychoeducational system when used by opioid-dependent patients in office-based buprenorphine treatment.

详细描述

The partial opioid agonist, buprenorphine, was recently approved by the FDA for the treatment of opioid-dependence and will be available via physician prescription, enabling a greatly needed expansion of access to opioid treatment services. However, physicians, because of considerable demands on their time, will likely be unable to provide or coordinate referral for opioid-dependent patients to receive supplemental educational interventions that are critical to the success of their treatment. To address this challenge, we are developing an interactive, web-based patient education system for opioid-dependent individuals in office-based buprenorphine treatment. In this system, we plan to provide patients with educational interventions of demonstrated efficacy (e.g., information about buprenorphine, HIV/AIDS education, relapse prevention skills training). In Phase I, we demonstrated the scientific, technical and commercial merit and feasibility of this web-based patient education system by developing several modules of the program as well as the appropriate technology for the program to be delivered in an office-based setting. We subsequently assessed these modules in the context of feedback sessions conducted with opioid-dependent individuals in a lab designed to mimic the technical constraints of a physician's office. Results demonstrated that this system represents a viable approach to patient education in office-based buprenorphine treatment. During Phase II, we plan to complete our research and development efforts on this project. We will complete all educational modules of the system. We will also develop a "customization program" that patients can use to help them identify the optimal order in which they may access the program modules while in treatment. Additionally, we will establish an electronic reporting system that will provide physicians prescribing buprenorphine with patient activity reports, enabling them to track and document patient progress through the system and ensure that patients are compliant with ancillary educational interventions. Additionally, we plan to conduct a randomized, controlled trial to evaluate the efficacy and cost-effectiveness of this patient education system delivered via the Internet compared to the delivery of patient educational services by community-based treatment facilities outside of the office-based setting. This system will provide patients, physicians and the larger community with assurance that patients in office-based buprenorphine treatment are receiving ancillary services along with their medication, thereby improving their likelihood for a successful treatment outcome.

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

  • Opioid dependence
  • Adults ( >/= 18 years)
  • In first month of office-based buprenorphine maintenance treatment

排除标准

  • In buprenorphine-assisted taper

结局指标

主要结局

opiate use

次要结局

  • psychosocial status
  • feedback on intervention
  • treatment retention
  • other drug use
  • HIV risk behavior
  • opiate craving

研究者

发起方
National Development and Research Institutes, Inc.
申办方类型
Other

研究点 (2)

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