Intensive Outpatient v. Outpatient Treatment with Buprenorphine among African Ame

非洲裔美国人中的重症门诊与丁丙诺啡门诊治疗

• 批准号: 7830858
• 负责人: Shannon Gwin Mitchell
• 金额: $ 49.87万
• 依托单位: FRIENDS RESEARCH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7830858
• 关键词: Abstinence; Accounting; Address; Adult; Affect; African; African American; Agonist; Alcohol consumption; Alcohol dependence; American; Area; Attitude; Baltimore; Buprenorphine; Caring; Cities; Clinic; Cocaine Dependence; Communities; Contracts; Counseling; DSM-IV; Data; Dependence; Disease remission; Distress; Dose; Drug Metabolic Detoxication; Drug abuse; Drug usage; Effectiveness; Evaluation; Frequencies; Funding; Grant; HIV; Health; Health Services Accessibility; Heroin; Hour; Illicit Drugs; Impairment; Individual; Insurance; Intake; Knowledge; Lead; Maryland; Measures; Medical; Medicine; Methadone; Naltrexone; Opiate Addiction; Opiates; Opioid; Outcome; Outcome Measure; Outcome Study; Outpatients; Partial Remission; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Physicians; Physicians' Offices; Population; Preclinical Drug Evaluation; Provider; Public Health; Quality of life; Randomized; Randomized Clinical Trials; Relapse; Relative (related person); Reporting; Research; Risk; Risk Behaviors; Sampling; Screening Result; Severities; Societies; Staff Attitudes; System; Test Result; Testing; Treatment Effectiveness; Treatment Protocols; Treatment outcome; United States Substance Abuse and Mental Health Services Administration; Urine; addiction; alcohol research; base; clinically significant; cocaine use; comparative effectiveness; design; dosage; drinking; drug testing; effective therapy; effectiveness research; ethnic minority population; experience; health disparity; innovation; novel; patient oriented; premature; primary outcome; programs; psychosocial; response; success; treatment program; urban area

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.

描述（由申请人提供）： 本申请涉及广泛的挑战领域 (05)：比较有效性研究，以及具体的挑战主题 (05-DA-104)：比较少数族裔人群的药物治疗效果 背景：尽管非洲裔美国人之间的非法药物使用率差异相对较小和白人之间，阿片类药物使用对这两个社区的附带影响存在显着差异，而且他们获得治疗的机会也存在巨大差异。丁丙诺啡是一种部分 mu 激动剂，于 2002 年在美国获准在严格监管的阿片类药物治疗计划之外使用，它有可能缩小治疗需求与治疗获取之间的差距。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异现在正在延伸到这种治疗。事实上，根据 SAMHSA 的数据，在评估这种治疗方法时接受丁丙诺啡治疗的患者中，90% 以上是白人。城市地区的许多非裔美国人无法找到或负担得起丁丙诺啡在医生办公室进行的治疗，而丁丙诺啡的批准原本是为了使这种治疗成为可能。在马里兰州和其他地方，戒毒治疗机构正在通过向传统上完全依赖心理社会方法（“无毒”门诊计划）进行治疗的戒毒治疗计划提供赠款或合同来应对丁丙诺啡治疗获取方面的差异。这种安排有可能改善非裔美国人的获取问题，在巴尔的摩，非裔美国人约占该市海洛因吸食人口的 80%。但这种安排也暴露了必须填补的知识空白，以便为这一人群提供获得和最佳以患者为中心的治疗。其中一个差距涉及什么水平的心理社会治疗适合这一人群。其次，我们需要了解以前以禁欲为导向的项目中工作人员的态度如何影响阿片类激动剂的治疗保留和结果的使用。设计：这项两组随机临床试验将测试 272 名海洛因依赖非裔美国成年人在 3 个以前的“无毒品”计划中接受丁丙诺啡的强化门诊 (IOP) 与标准门诊 (OP) 治疗的有效性。参与者将在摄入时被随机分配到两种治疗强度条件之一，并在基线、基线后 3 个月和 6 个月进行评估，以确定治疗保留情况、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，并确定阿片类药物依赖完全或部分缓解的 DSM-IV 标准。此外，将检查对治疗成功可能至关重要的患者因素（例如，治疗期间对丁丙诺啡的态度和平均丁丙诺啡剂量），以确定它们在影响治疗结果中的重要性。此外，还将评估患者和工作人员的态度以及平均丁丙诺啡剂量，以确定它们各自与治疗经历和治疗保留的关系。意义、创新和公共卫生影响：这项研究意义重大，因为它将检验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，这些非裔美国人对这种有效治疗的需求很大，但获得这种有效治疗的机会有限。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有关两种强度咨询水平的相对益处，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 缓解标准作为结果衡量标准之一代表了对常见药物滥用研究结果衡量标准的重要增强，通常药物滥用研究结果衡量标准通常主要依赖于尿液检测结果和药物使用自我报告作为主要结果衡量标准并且不考虑药物相关的临床显着损害或痛苦的减少，尽管有些人继续间歇性使用药物。公共卫生声明 这项研究将检验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，这些人群对这种有效治疗的需求很大，但获得这种有效治疗的机会有限，这种治疗可以减少吸毒和艾滋病毒风险。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有关两种强度咨询水平的相对益处，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。