Drug Counseling and Abstinent-Contingent Take Home Buprenorphine in Malaysia

马来西亚的药物咨询和戒毒者带回家丁丙诺啡

基本信息

批准号：
8134446
负责人：
Richard S Schottenfeld
金额：
$ 28.75万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
起止时间：
2001-09-30 至 2014-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8134446
关键词：
AIDS prevention Abstinence Accounting Achievement Acquired Immunodeficiency Syndrome Address Adherence Amphetamines Automobile Driving Behavior Therapy Behavioral Buprenorphine Characteristics Clinic Clinical Contracts Counseling Country Data Analyses Dose Drug abuse Drug usage Effectiveness Employment Epidemic Family Follow-Up Studies HIV Health Professional Health Services Heroin Home environment Hospitalization Illicit Drugs Imprisonment Incentives Injection of therapeutic agent Intention Letters Maintenance Malaysia Manuals Medical Mentors Methadone Naltrexone Narcotics Nurses Opiates Outcome Measure Patients Personal Communication Pharmaceutical Preparations Pharmacy facility Physicians Physicians&apos Offices Placebos Policies Practice Guidelines Prevention Research Provider Psychiatric Social Work Randomized Randomized Clinical Trials Relapse Research Research Personnel Risk Behaviors Risk Reduction Sampling Services Stigmata Subgroup Testing Time Training Treatment Cost Urine Work base clinical practice cost cost effective cost effectiveness criminal behavior drug efficacy economic cost experience flexibility improved medication compliance methadone maintenance primary outcome prognostic programs response secondary outcome sex social stigma stimulant abuse treatment program

项目摘要

DESCRIPTION (provided by applicant): Heroin and injection drug use (IDU) are highly prevalent and driving the HIV epidemic in Malaysia and other countries in the region. In our original RCT, buprenorphine (BUP) was superior to naltrexone and placebo in treatment retention, weeks of consecutive abstinence and time to heroin use. However, there is room for improvement, since only 50% of subjects assigned to BUP remained in treatment for 6 months; only 28% avoided relapse to heroin; and BUP reduced drug- but not sex-related HIV risk behaviors. In actual clinical practice in Malaysia and the U.S., Standard BUP is provided with relatively minimal psychosocial services (brief physician management (PM) and weekly or less frequent medication pick-up) and may be even less effective. Hence, we propose a follow up study to evaluate whether Standard BUP is sufficient or whether one or a combination of two enhanced behavioral treatments-behavioral drug and HIV risk reduction counseling (BDRC) or abstinence-contingent take-home buprenorphine (ACB)-improve its efficacy and are cost-effective, with regard to the direct economic costs of providing the treatments. BDRC utilizes short-term behavioral contracts to promote abstinence and reduce drug- and sex-related HIV risk behaviors and can be provided by nurses and medical assistants available in medical settings in Malaysia. ACB, a low cost and feasible alternative to non-contingent take-home buprenorphine, retains many of its advantages-abstinent patients manage their medication supplies outside of the clinic-but ACB also provides positive incentives for abstinence and directly observed buprenorphine for those with continuing heroin use. In the proposed 2X2 study, heroin dependent patients (N=240) will be inducted onto buprenorphine (weeks 1-2) and then randomized to Standard BUP, Standard BUP with ACB, Standard BUP with BDRC, or Standard BUP with both (weeks 3-26). Primary outcome measures include reductions in heroin use (percent days abstinent, proportion of opiate-negative urine tests, and maximum consecutive weeks abstinent) and reductions in drug- and sex-related HIV risk behaviors. Secondary outcomes include retention; reductions in other drug use, hospitalizations, criminal behavior and arrests; and improvements in vocational and family functioning. Data analyses will focus on the intention-to treat sample. The study results will inform practice guidelines and policies regarding buprenorphine treatment.

描述（由申请人提供）：海洛因和注射毒品使用（IDU）非常普遍，并在马来西亚和该地区其他国家驱动艾滋病毒流行。在我们最初的RCT中，丁丙诺啡（BUP）优于纳曲酮，在治疗保留率，连续的禁欲和海洛因使用时间中，丁香酮和安慰剂优于。但是，由于只有50％的受试者在治疗中保留了6个月，因此还有改进的空间。只有28％避免复发为海洛因； BUP减少了药物，但没有与性别相关的艾滋病毒风险行为。在马来西亚和美国的实际临床实践中，标准BUP提供了相对最小的社会心理服务（简短的医师管理（PM）和每周或更少的频率接种药物），并且效果可能更低。因此，我们提出了一项后续研究，以评估标准BUP是否足够，或者是两种增强的行为治疗 - 行为和艾滋病毒风险降低咨询（BDRC）还是戒酒 - 持续性抗议者（ACB） - Improve-关于提供治疗的直接经济成本，它的功效和具有成本效益。 BDRC利用短期行为合同来促进禁欲并减少与毒品和性别相关的艾滋病毒风险行为，可以由马来西亚医疗环境中提供的护士和医疗助手提供。 ACB是非危机带室丁丙诺啡的低成本和可行的替代品，保留了许多优势 - 遗憾的患者在诊所外管理其药物供应，但ACB以外的药物供应也提供了积极的戒酒激励措施，并直接观察到buprenorphine to torgrenorphine海洛因使用。在拟议的2x2研究中，将海洛因依赖性患者（n = 240）感应到丁丙诺啡（第1-2周），然后随机分配给标准BUP，带有ACB的标准BUP，带有BDRC的标准BUP或两者的标准BUP（第3周） -26）。主要结局指标包括减少海洛因使用（戒酒百分比，鸦片阴性的比例比例，连续几周都禁止使用）以及毒品和性别相关的HIV风险行为的减少。次要结果包括保留；减少其他药物使用，住院，犯罪行为和逮捕；并改善职业和家庭功能。数据分析将集中在目的治疗样本上。该研究结果将为实践指南和有关丁丙诺啡治疗的政策提供信息。