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临床试验/NCT00182572
NCT00182572Unknown2 期

Science-Based Treatment for Opioid-Dependent Adolescents

National Development and Research Institutes, Inc.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2005年7月1日最近更新:
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试验速览

阶段
2 期
发起方
入组人数
80
试验地点
1
主要终点
opiate use

研究概览

简要总结

The purpose of this study is to evaluate ways to optimize outcomes from combined behavioral-pharmacological treatment for opioid-dependent youth.

详细描述

Adolescents are increasingly abusing and becoming dependent on heroin and other opioids. The number of emergency room visits related to heroin among 12-17 year olds rose almost 600%, and the self-reported prevalence of heroin use among this group more than doubled in the last decade. As a result of the increased availability of high-potency, low-cost heroin, many adolescents initiate heroin use by snorting it; however, many often then progress to injection of heroin. Despite the critical need to identify efficacious treatments for this population, virtually no research has been conducted to systematically characterize or evaluate treatment interventions for adolescent heroin and opioid abusers. We recently conducted the first controlled study funded by NIDA to systematically evaluate the efficacy of several pharmacotherapies as detoxification agents along with intensive behavioral interventions in the treatment of this population. The purpose of this study is to evaluate ways to further improve on the promising outcomes from our initial study via combined behavioral-buprenorphine treatment for opioid-dependent youth. The primary aim is to examine if improved treatment outcomes can be achieved if the duration of buprenorphine detoxification is lengthened (when the rate of decrease in buprenorphine dose is slower, withdrawal symptoms may be of reduced intensity and youth are provided with a greater opportunity to learn new skills and behaviors addressing how they might best discontinue their opiate use, prevent relapse, and meet treatment goals). A secondary aim is to examine if the provision of monetary voucher-based incentives contingent on consumption of the opioid antagonist, naltrexone, reduces rates of relapse to opiate use in adolescents post-detoxification compared to when no such incentives are provided. This analysis may provide critical empirical information regarding how to best prevent relapse to opioid use among opioid-dependent youth. Another secondary aim is to identify significant predictors of treatment outcome. We will thus conduct an exploratory evaluation of demographic, baseline drug use, psychological and other history variables that may predict successful treatment outcomes. This work may help inform the refinement of treatment interventions for various sub-populations of opioid-dependent youth. Outcome measures will include opiate and other drug abstinence, retention, opiate withdrawal symptoms, HIV risk behavior, family relationships, as well as a variety of other secondary outcome measures. We plan to collect these measures at intake, during treatment and at several post-treatment follow-up timepoints. Overall, this research will contribute new empirical information that will inform the development of effective treatment interventions for the largely unstudied and rapidly expanding population of opioid-dependent youth.

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

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of opioid dependence
  • ages 13-18 years

排除标准

  • active psychosis
  • active suicidality
  • major medical problems (e.g., cardiovascular disease)
  • pregnancy
  • require inpatient detoxification from non-opiate drugs

结局指标

主要结局

opiate use

次要结局

  • treatment retention
  • other drug use
  • HIV risk behavior
  • opiate agonist and withdrawal effects
  • psychological status
  • family relations
  • motivation to change drug use
  • opiate craving
  • criminal activity

研究者

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

研究点 (1)

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