Intensive Outpatient v. Outpatient Treatment with Buprenorphine among African Ame

描述（由申请人提供）： 此应用程序解决了广泛的挑战领域（05）：比较有效性研究，和特定的挑战主题（05-DA-104）：在少数民族人群中比较药物治疗效果背景：尽管非裔美国人和白人之间的非法药物使用率差异相对较小，使用阿片剂对这两个社区的附带影响有很大差异，在获得治疗方面也有很大差距。丁丙诺啡是一种部分mu激动剂，2002年在美国批准在严格监管的阿片类药物治疗计划之外使用，有可能减少治疗需求和治疗获得之间的差距。然而，从美国实施丁丙诺啡的早期数据来看，非裔美国人面临的健康差距现在正在扩大到这种治疗。事实上，根据SAMHSA，在接受丁丙诺啡治疗的患者中，超过90%的患者是白色。城市地区的许多非洲裔美国人无法找到或负担得起丁丙诺啡批准的丁丙诺啡医生办公室治疗。在马里兰州和其他地方，药物治疗机构正在通过向传统上完全依赖心理社会方法（“无毒”门诊方案）治疗的药物治疗方案提供赠款或合同来应对丁丙诺啡治疗的不平等。这种安排有可能改善非洲裔美国人的准入问题，他们在巴尔的摩占该市海洛因使用人口的80%左右。但是，这种安排也揭示了必须填补的知识空白，以便为这一人群提供以患者为中心的最佳治疗。其中一个差距涉及到什么程度的心理治疗适合于这一人群。其次，我们需要了解以前禁欲导向项目的工作人员的态度如何影响阿片类激动剂在治疗和结果中的保留。设计图：这项两组随机临床试验将在272名海洛因依赖的非洲裔美国成年人中测试强化门诊（IOP）与标准门诊（OP）治疗的有效性，这些成年人在3个以前的“无毒”项目中接受丁丙诺啡。参与者将在摄入时被随机分配到两种治疗强度条件之一中，并在基线、基线后3个月和6个月进行评估，以确定治疗保留、海洛因和可卡因使用的频率和严重程度、自我报告的HIV风险、生活质量，并确定DSM-IV阿片类药物依赖完全或部分缓解的标准。此外，患者因素可能对治疗成功至关重要（例如，对丁丙诺啡的态度和治疗时的平均丁丙诺啡剂量），以确定它们在影响治疗结果方面的重要性。此外，将评价患者和工作人员的态度以及平均丁丙诺啡剂量，以确定其各自与治疗经验和治疗保留的关系。意义，创新和公共卫生影响：这项研究意义重大，因为它将研究在治疗大量非裔美国人的诊所中使用丁丙诺啡提供的两种常见咨询方法的比较有效性，这是一个有显著需求且获得这种类型有效治疗的有限人群。研究结果可能有助于扩大丁丙诺啡对非裔美国人的可用性，告知提供者和政策制定者两种强度咨询的相对好处，并告知该领域与最佳丁丙诺啡利用和计划保留相关的因素。使用DSM-IV缓解标准作为结局指标之一，代表了常规药物滥用研究结局指标的重要增强，常规药物滥用研究结局指标通常主要依赖于尿检结果和药物使用的自我报告作为主要结局指标，并且不考虑药物相关的临床显著损害或痛苦的减少，尽管有一些持续的间歇性药物使用。本研究将检查两种常见的咨询方法的比较有效性，这些方法在治疗大量非裔美国人的诊所中使用丁丙诺啡，这些人对这种有效治疗有显著的需求，但获得这种有效治疗的机会有限，可以减少药物使用和艾滋病毒风险。研究结果可能有助于扩大丁丙诺啡对非裔美国人的可用性，告知提供者和政策制定者两种强度咨询的相对好处，并告知该领域与最佳丁丙诺啡利用和计划保留相关的因素。

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (05): Comparative Effectiveness Research, and specific Challenge Topic (05-DA-104): Comparing Drug Treatment Effectiveness in Ethnic Minority Populations Background: Although there is relatively little difference in illicit drug use rates between African Americans and Whites, there is are significant differences in terms of the collateral impact of opiate use on these two communities and wide disparities in their access to treatment. Buprenorphine, a partial mu agonist approved for use the US in 2002 outside of strictly regulated opioid treatment programs, has the potential to reduce the disparity between demand for treatment and treatment access. However it appears from early data on the implementation of buprenorphine in the US that the health disparities faced by African Americans are now extending to this treatment. Indeed, according to SAMHSA over 90 percent of the patients receiving buprenorphine in their evaluation of this treatment were White. Many African Americans in urban areas are unable to find or afford the kind of buprenorphine physician office-based treatment that the approval of buprenorphine was intended to make possible. In Maryland and elsewhere, drug treatment agencies are responding to the disparities in access to buprenorphine treatment by offering grants or contracts to drug treatment programs that have traditionally relied exclusively on psychosocial approaches ("drug-free" outpatient programs) to treatment. This arrangement has potential to ameliorate the access problem for African Americans, who in Baltimore make up about 80 percent of the city's heroin-using population. But this arrangement has also uncovered knowledge gaps that must be filled to enable both access and optimal patient centered treatment for this population. One such gap concerns what level of psychosocial treatment is appropriate for this population. Second, we need to understand how attitudes of staff at formerly abstinence-oriented programs affect the use of an opioid agonist in terms of retention in treatment and outcomes. Design: This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 3 formerly "drug-free" programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention. Significance, Innovation and Public Health Impact: This study is significant because it will examine the comparative effectiveness of two common counseling approaches offered with buprenorphine in clinics treating large numbers of African Americans, a population with significant need and limited access to this type of effective treatment. Study findings may help to expand the availability of buprenorphine to African Americans, inform providers and policymakers regarding the relative benefits of two levels of intensity of counseling, and inform the field regarding factors associated with optimal buprenorphine utilization and program retention. The use of the DSM-IV criteria for remission as a one of the outcome measures represents an important augmentation of the usual drug abuse research outcome measures, which usually rely primarily upon urine testing results and self-reports of drug use as the primary outcome measure and do not take into account drug- related reductions in clinically significant impairment or distress, despite some continued intermitted drug use. Public Health Statement This study will examine the comparative effectiveness of two common counseling approaches offered with buprenorphine in clinics treating large numbers of African Americans, a population with significant need and limited access to this type of effective treatment which reduces drug use and HIV-risk. Study findings may help to expand the availability of buprenorphine to African Americans, inform providers and policymakers regarding the relative benefits of two levels of intensity of counseling, and inform the field regarding factors associated with optimal buprenorphine utilization and program retention.