Interim Buprenorphine Treatment to bridge waitlist delays: Stage II evaluation

临时丁丙诺啡治疗以弥补等候名单延误：第二阶段评估

• 批准号: 9547358
• 负责人: STACEY C SIGMON
• 金额: $ 75.15万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9547358
• 关键词: Abstinence; Adoption; Adult; Anxiety; Area; Back; Behavior Therapy; Buprenorphine; Cessation of life; Clinic; Clinic Visits; Communicable Diseases; Costs and Benefits; Counseling; County; Data; Devices; Dose; Drug usage; Economics; Education; Effectiveness; Enrollment; Epidemic; Evaluation; Federally Qualified Health Center; Finland; Frequencies; HIV; Hepatitis; Home environment; Individual; Integrative Therapy; Intervention; Knowledge; Life; Maintenance; Measures; Mental Depression; Methadone; Opiate Addiction; Opioid; Opioid abuser; Outcome; Overdose; Participant; Patients; Pharmacotherapy; Pilot Projects; Prevention education; Provider; Public Health; Randomized; Recording of previous events; Reporting; Research; Risk; Rural; Safety; Sample Size; Sampling; Savings; Secure; Site; System; Telephone; Testing; Treatment Cost; Treatment Efficacy; Universities; Urinalysis; Vermont; Visit; Voice; Waiting Lists; Withdrawal; buprenorphine treatment; computerized; conventional therapy; cost effectiveness; craving; economic cost; experience; illicit drug use; illicit opioid; improved; medical specialties; methadone treatment; novel; opioid abuse; opioid agonist therapy; opioid overdose; opioid use; overdose death; overdose prevention; pill; portability; premature; programs; psychosocial; randomized trial; recruit; response; rural environment; societal costs; therapy development; treatment choice; treatment effect

PROJECT SUMMARY Despite the efficacy of opioid maintenance and alarming increases in overdose (OD) deaths, waiting lists for treatment persist. During these treatment delays opioid abusers are at risk for illicit drug use, criminal activity, infectious disease, OD and premature death. With a Behavioral & Integrative Treatment Development R34, we have developed an Interim Buprenorphine Treatment (IBT) for waitlisted opioid abusers that includes four key components: Buprenorphine dispensed via secure computerized device; nightly calls from an Interactive Voice Response (IVR) phone system assessing drug use, withdrawal and craving; IVR-generated random call-backs; HIV+Hepatitis Education delivered via iPad. Our Stage I data strongly support the initial efficacy of IBT, with 87%, 87% and 75% of IBT participants abstinent at Weeks 4, 8 and 12 vs. 0%, 0% and 0% of Waitlist Control (WLC) participants (p<.0001). IBT participants are also reporting greater reductions in IV drug use frequency (p<.001) and completing 95% of daily IVR calls and random call-backs. Consistent with the R34 mechanism, our pilot study involved a limited sample size (n=48) and a single academic research clinic. It is important to evaluate whether these extremely promising results are replicated when implemented on a larger scale. Primary Aim: In this Stage II randomized trial, we evaluate IBT efficacy in 200 waitlisted opioid-dependent adults. UVM will serve as the coordinating center and primary recruitment site where we will enroll 100 participants. We will partner with federally qualified health centers in two rural Vermont counties to enroll 50 participants per site. IBT participants will receive the intervention above; WLC participants will remain on waitlists but complete the same 4-, 8- and 12-week assessments. We hypothesize that IBT participants will achieve significantly greater illicit opioid abstinence relative to WLC participants. Secondary Aims: (1) While our pilot study suggests some IBT-related benefits beyond abstinence per se, it was insufficiently powered to examine IBT effects other than abstinence. This trial will permit us to thoroughly examine IBT's broader impacts in important areas of psychosocial functioning. (2) Data from our R34 indicate that education around opioid OD prevention is an area of critical need for these patients. We will develop and evaluate an OD prevention education. (3) While favorable cost-benefit outcomes have been demonstrated for conventional methadone and buprenorphine treatment, no study has investigated the cost effectiveness of IBT. We will conduct economic analyses that will inform providers' decisions around IBT adoption. This project builds directly on the promising results from our Stage I research and is poised to reduce the vast economic and societal costs associated with opioid treatment delays. By facilitating the eradication of waitlists, this project represents a significant departure from the status quo and stands to produce a fundamental shift in how treatment of opioid dependence is conceptualized and delivered.

项目概要 尽管阿片类药物维持治疗有效且服药过量 (OD) 死亡人数惊人增加，但等候名单 以便治疗坚持。在这些治疗延误期间，阿片类药物滥用者面临非法药物使用、刑事犯罪的风险 活动、传染病、OD 和过早死亡。随着行为和综合治疗的发展 R34，我们为等候名单上的阿片类药物滥用者开发了一种临时丁丙诺啡治疗 (IBT)， 包括四个关键成分： 通过安全的计算机化设备分配丁丙诺啡；每晚打来的电话 交互式语音应答（IVR）电话系统评估药物使用、戒断和渴望； IVR 生成 随机回调；通过 iPad 提供 HIV+肝炎教育。我们的第一阶段数据强烈支持最初的 IBT 的功效，87%、87% 和 75% 的 IBT 参与者在第 4、8 和 12 周戒酒，而 0%、0% 和 0% 候补名单控制 (WLC) 参与者的数量 (p<.0001)。 IBT 参与者还报告了 IV 的更大减少 药物使用频率 (p<.001) 以及完成 95% 的每日 IVR 呼叫和随机回电。 与 R34 机制一致，我们的试点研究涉及有限的样本量 (n=48) 和单个 学术研究诊所。评估这些极具前景的结果是否能够被复制非常重要 当更大规模地实施时。主要目标：在这项 II 期随机试验中，我们评估 IBT 疗效 200 名等候名单上的阿片类药物依赖成年人。 UVM将作为协调中心和主要招聘 我们将在该网站上招募 100 名参与者。我们将与两个农村地区具有联邦资格的医疗中心合作 佛蒙特州各县每个地点招收 50 名参与者。 IBT参与者将接受上述干预；无线控制器 参与者将保留在候补名单上，但完成相同的 4 周、8 周和 12 周评估。我们假设 相对于 WLC 参与者，IBT 参与者将实现更大程度的非法阿片类药物戒断。 次要目标：(1) 虽然我们的试点研究表明除了禁欲本身之外还有一些与 IBT 相关的益处，但它 除了禁欲之外，没有足够的能力来检查 IBT 的影响。这次试验将使我们彻底 检查 IBT 对心理社会功能重要领域的更广泛影响。 (2) 我们的 R34 数据表明 关于阿片类药物过量预防的教育是这些患者迫切需要的一个领域。我们将开发和 评估 OD 预防教育。 (3) 虽然已经证明了良好的成本效益结果 与传统的美沙酮和丁丙诺啡治疗相比，没有研究调查 IBT 的成本效益。 我们将进行经济分析，为提供商围绕 IBT 采用的决策提供信息。 该项目直接建立在我们第一阶段研究的有希望的结果的基础上，并准备减少 与阿片类药物治疗延误相关的巨大经济和社会成本。通过促进根除 候补名单，该项目与现状有很大的不同，并将产生一个 阿片类药物依赖治疗的概念化和实施方式发生了根本性转变。