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: 9216519
• 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/9216519
• 关键词: Abstinence; Adoption; Adult; Agonist; Anxiety; Area; Back; Behavioral; 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; Intervention; Knowledge; Life; Maintenance; Measures; Mental Depression; Methadone; Opiate Addiction; Opioid; Outcome; Overdose; Participant; Patients; Pharmacotherapy; Phonation; Pilot Projects; Prevention education; Provider; Public Health; Randomized; Recording of previous events; Recruitment Activity; 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; computerized; conventional therapy; cost; cost effectiveness; craving; experience; illicit drug use; improved; medical specialties; novel; opioid abuse; opioid use; overdose death; overdose prevention; pill; portability; premature; programs; psychosocial; randomized trial; response; rural environment; therapy development; treatment choice; treatment effect; Abstinence; Adoption; Adult; Agonist; Anxiety; Area; Back; Behavioral; 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; Intervention; Knowledge; Life; Maintenance; Measures; Mental Depression; Methadone; Opiate Addiction; Opioid; Outcome; Overdose; Participant; Patients; Pharmacotherapy; Phonation; Pilot Projects; Prevention education; Provider; Public Health; Randomized; Recording of previous events; Recruitment Activity; 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; computerized; conventional therapy; cost; cost effectiveness; craving; experience; illicit drug use; improved; medical specialties; novel; opioid abuse; opioid use; overdose death; overdose prevention; pill; portability; premature; programs; psychosocial; randomized trial; response; rural environment; 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.

项目摘要 尽管阿片类药物维护和过量死亡的令人震惊的增加，但候补名单有效 治疗持续存在。在这些治疗期间，阿片类药物滥用者有非法吸毒的风险，刑事 活动，传染病，OD和过早死亡。采用行为和综合治疗开发 R34，我们已经开发了一种临时丁丙诺啡治疗（IBT），用于等待列表的阿片类药物滥用者 包括四个关键组件：通过安全的计算机设备分配的丁丙诺啡；每晚打来的电话 交互式语音响应（IVR）电话系统评估吸毒，戒断和渴望； IVR生成 随机呼叫回扣；通过iPad进行的HIV+肝炎教育。我们的阶段I数据强烈支持初始 IBT的疗效，在第4、8和12周拒绝IBT参与者的87％，87％和75％ 候补名单控制（WLC）参与者的参与者（p <.0001）。 IBT参与者还报告了IV的降低 药物使用频率（p <.001），并完成95％的每日IVR呼叫和随机呼叫。 与R34机制一致，我们的试点研究涉及样本量有限（n = 48）和一个单一的 学术研究诊所。评估这些极有前途的结果是否复制很重要 当更大规模实施时。主要目的：在此阶段II随机试验中，我们评估IBT效力 在200名候补名单依赖性成年人中。 UVM将作为协调中心和初级招聘 我们将在这里注册100名参与者。我们将与两个农村的联邦资格卫生中心合作 佛蒙特州县将招募50名参与者。 IBT参与者将获得上述干预措施； WLC 参与者将保留在候补名单上，但要完成相同的4票，8和12周的评估。我们假设 相对于WLC参与者，IBT参与者将获得更大的非法阿片类药物禁欲。 次要目的：（1）我们的试点研究表明，本质上的戒酒超出了与IBT相关的一些好处 除了禁欲以外，还没有足够的动力检查IBT效应。该审判将使我们彻底 检查IBT在社会心理功能的重要领域的更广泛影响。 （2）我们R34的数据表示 围绕阿片类药物预防的教育是这些患者至关重要的领域。我们将发展和 评估预防教育。 （3）虽然已经证明了有利的成本效益结果 常规美沙酮和丁丙诺啡治疗，没有研究研究IBT的成本效益。 我们将进行经济分析，这些分析将为提供者围绕IBT采用的决定提供依据。 该项目直接建立在我们阶段I研究的有希望的结果的基础上，并有望减少 与阿片类药物治疗延迟有关的巨大经济和社会成本。通过促进根除 候补名单，该项目代表了与现状的重大背离，并产生了一个 阿片类药物依赖治疗的基本转变是概念性和交付的。