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

• 批准号: 7496644
• 负责人: Richard S Schottenfeld
• 金额: $ 8.54万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7496644
• 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; Economics; Effectiveness; Employment; Epidemic; Family; Follow-Up Studies; HIV; Health Professional; Health Services; Heroin; Home environment; Hospitalization; Illicit Drugs; Imprisonment; Incentives; Injection of therapeutic agent; Letters; Maintenance; Malaysia; Manuals; Medical; Mentors; Methadone; Naltrexone; Narcotics; Nurses; Opiates; Outcome; Outcome Measure; Patients; Personal Communication; Pharmaceutical Preparations; Pharmacy facility; Physicians; Physicians' Offices; Placebos; Pliability; Policies; Practice Guidelines; Prevention Research; Provider; Psychiatric Social Work; Randomized; Randomized Clinical Trials; Relapse; Research; Research Personnel; Risk Behaviors; Risk Reduction; Sampling; Services; Standards of Weights and Measures; Stigmata; Subgroup; Testing; Time; Training; Treatment Cost; Urine; Week; Work; base; cost; cost effectiveness; criminal behavior; day; drug efficacy; experience; improved; medication compliance; prognostic; programs; response; sex; social stigma; stimulant abuse; treatment program

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.

海洛因和注射毒品使用（IDU）非常普遍，并推动了马来西亚和其他国家的艾滋病毒流行。 该地区的国家。在我们最初的RCT中，丁丙诺啡（BUP）在以下方面上级纳洛酮和安慰剂： 治疗保留，连续戒断周数和海洛因使用时间。然而，有空间， 改善，因为分配至BUP组的受试者中只有50%的受试者保持治疗6个月;只有28%的受试者保持治疗6个月。 避免了海洛因的复吸; BUP减少了与毒品有关的艾滋病毒风险行为，但没有减少与性有关的艾滋病毒风险行为。实际临床 在马来西亚和美国的实践，标准BUP提供相对最少的心理社会服务 （简短的医生管理（PM）和每周或更少频率的药物取药），甚至可能更少 有效因此，我们建议进行一项后续研究，以评估标准BUP是否足够，或者 一种或两种强化行为治疗的组合-行为药物和降低艾滋病毒风险 咨询（BDRC）或戒断应急带回家丁丙诺啡（ACB）提高其功效， 就提供治疗的直接经济成本而言，具有成本效益。BDRC利用短期 行为契约，以促进禁欲，减少与毒品和性有关的艾滋病毒风险行为， 由马来西亚医疗机构的护士和医疗助理提供。ACB是一种低成本， 可行的替代非特遣队带回家丁丙诺啡，保留了许多其优点-禁欲 病人在诊所外管理他们的药物供应，但ACB也提供了积极的激励措施， 戒断和直接观察丁丙诺啡对于那些继续使用海洛因。在建议的2X2 在一项研究中，海洛因依赖患者（N=240）将接受丁丙诺啡（第1-2周），然后 随机分配至标准BUP、标准BUP + ACB、标准BUP + BDRC或标准BUP + 两者（第3-26周）。主要结果指标包括海洛因使用的减少（禁欲天数百分比， 鸦片剂尿检呈阴性的比例和最长连续戒断周数）以及 与毒品和性有关的艾滋病毒危险行为。次要结局包括保留;减少其他药物 使用，住院，犯罪行为和逮捕;以及职业和家庭功能的改善。 数据分析将侧重于意向治疗样本。研究结果将告知实践指南 以及丁丙诺啡治疗的政策