The National Drug Abuse Clinical Trials Network: New England Consortium Node
国家药物滥用临床试验网络:新英格兰联盟节点
基本信息
- 批准号:10451986
- 负责人:
- 金额:$ 23.31万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-09-01 至 2022-02-28
- 项目状态:已结题
- 来源:
- 关键词:AddressAdherenceAgonistBehavior TherapyBehavioralBuprenorphineClinical TrialsClinical Trials NetworkDirectly Observed TherapyDrug abuseHealth PersonnelHealth systemLearningMedicineMeta-AnalysisMethadoneMethodsNew EnglandOpiate AddictionOpioidPatient PreferencesPatientsPharmaceutical PreparationsPharmacy facilityPrimary Health CareProviderPsychiatryQualitative ResearchRandomizedResearchResearch PersonnelServicesSiteSystemTestingTrainingUnited Statesaddictionbasebuprenorphine treatmentchronic paincomparative effectivenesseffectiveness evaluationeffectiveness implementation studyeffectiveness implementation trialexperiencehigh riskimplementation barriersimplementation facilitatorsimplementation frameworkimplementation scienceopioid treatment programopioid use disorderpolysubstance useprescription opioidrural disparities
项目摘要
There is an urgent need to address sub-optimal retention in office-based buprenorphine (BUP) and
expand access to methadone outside of opioid treatment programs (OTP). Meta-analyses and CTN
0027 demonstrate that retention in methadone is higher than BUP. Factors contributing to low retention
in office-based BUP may include lower agonist activity, poor BUP adherence, polysubstance use,
insufficient behavioral services, patient preference, and co-occurring conditions (i.e., chronic pain).
Clinicians currently have 2 options for patients not optimally benefitting from office-based BUP. They
can attempt to enhance BUP services or refer the patient to an OTP for methadone. We propose to
evaluate a needed new option – office-based methadone prescribing (under a research exemption to
the Controlled Substance Act) with methadone dispensing at a pharmacy or medication dispensing unit.
Simultaneously, access to medications for opioid use disorder in the United States is characterized by
profound racial and urban/rural disparities which could also be addressed by office-based methadone.
We propose to conduct a 6 site hybrid effectiveness implementation trial to compare: 1) Office-based
methadone where the current office-based BUP prescriber manages a switch to and continuation of
methadone in partnership with a local methadone dispensing facility (pharmacy or other OTP-affiliated
medication unit) versus; 2) Enhanced BUP where the office-based BUP provider continues BUP
treatment while providing enhanced behavioral treatment and/or implementing strategies to address
adherence if indicated (directly observed therapy, thrice-weekly BUP, or extended-release BUP), in 520
patients not optimally benefiting from office-based BUP. In Aim 1 we will train 6 large office-based BUP
sites to provide methadone with offsite administration/dispensing. In Aim 2 we will evaluate the
comparative effectiveness of office-based methadone versus Enhanced BUP on treatment retention at
6 months after randomization. In Aim 3 we will use mixed methods and an implementation science
framework to identify implementation barriers and facilitators at the patient, provider and health-
systems level for office-based methadone. Our team comprising early stage investigators, stakeholders
and people with lived experience, established researchers trained in primary care, addiction
medicine/psychiatry, clinical trials, disparities, qualitative research and implementation science has
experience conducting research in the CTN, evaluating office-based buprenorphine, office-based
methadone and pharmacy-based dispensing of methadone. This would be the first study to: 1)
capitalize on experienced BUP prescribers who would learn to prescribe methadone; 2) evaluate the
effectiveness office-based methadone in patients at high risk for not being retained in BUP; and 3)
assess patient and system barriers and facilitators to office-based methadone.
迫切需要解决基于办公室的丁丙诺啡(BUP)的次优保留问题
扩大在阿片类药物治疗计划(OTP)之外获得美沙酮的机会。Meta分析与CTN
0027表明美沙酮在美沙酮中的保留率高于BUP。导致保留率低的因素
办公室基础BUP可能包括激动剂活性较低、BUP依从性差、多物质使用
行为服务不足、患者偏好和共生情况(如慢性疼痛)。
对于没有从办公室BUP中获得最佳益处的患者,临床医生目前有两种选择。他们
可尝试加强BUP服务或转介患者到OTP接受美沙酮治疗。我们建议
评估所需的新选项-基于办公室的美沙酮处方(根据研究豁免
受控物质法),在药房或药物配药单位配发美沙酮。
同时,在美国获得治疗阿片类药物使用障碍的药物的特点是
严重的种族和城乡差距,也可以通过办公室使用的美沙酮来解决。
我们建议进行6个站点的混合有效性实施试验,以比较:1)基于办公室的
美沙酮,目前办公室的BUP处方员管理切换到并继续
美沙酮与当地美沙酮配药设施(药房或其他与OTP有关的机构)合作
药物单位)与;2)增强的BUP,其中基于办公室的BUP提供者继续BUP
治疗,同时提供增强的行为治疗和/或实施战略来解决
依从性(直接观察治疗、每周三次BUP或缓释BUP),在520
患者没有从基于办公室的BUP中获得最佳好处。在目标1中,我们将培训6个大型办公室BUP
为美沙酮提供异地给药/配药的地点。在目标2中,我们将评估
办公室美沙酮与增强型BUP治疗滞留的疗效比较
随机化后6个月。在目标3中,我们将使用混合方法和实施科学
框架,以确定患者、提供者和医疗保健方面的实施障碍和促进者-
办公用美沙酮的系统级别。我们的团队由早期调查人员、利益相关者组成
有生活经验的人,受过初级保健、成瘾培训的知名研究人员
医学/精神病学、临床试验、差异、定性研究和实施科学
在CTN进行研究、评估办公室用丁丙诺啡、办公室用丁丙诺啡的经验
美沙酮及药房美沙酮配药。这将是第一次对以下内容进行研究:1)
利用经验丰富的BAP处方师,他们将学习开美沙酮;2)评估
未保留在BUP中的高危患者的有效性办公室美沙酮;以及3)
评估患者和系统障碍以及办公室用美沙酮的促进者。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Gail D'Onofrio其他文献
Gail D'Onofrio的其他文献
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{{ truncateString('Gail D'Onofrio', 18)}}的其他基金
Yale-METRO Metropolitan Emergency Trial netwoRK to advance patient Outcomes
耶鲁大学-METRO 大都会紧急试验网络可改善患者的治疗效果
- 批准号:
10552382 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
Clinical Trials Network: Admin Supplement: Integrating MOUD with BUP in Non-medical Community Settings
临床试验网络:管理补充:在非医疗社区环境中将 MOUD 与 BUP 集成
- 批准号:
10801347 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
Standard versus High Dose ED-Initiated Buprenorphine Induction
标准剂量与高剂量 ED 引发的丁丙诺啡诱导
- 批准号:
10801950 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
Clinical Trials Network New England Consortium Node: Admin Supplement CTN0131
临床试验网络新英格兰联盟节点:管理补充 CTN0131
- 批准号:
10655837 - 财政年份:2022
- 资助金额:
$ 23.31万 - 项目类别:
National Institute on Drug Abuse Clinical Trial Network: New England Consortium Node
国家药物滥用研究所临床试验网络:新英格兰联盟节点
- 批准号:
10684501 - 财政年份:2022
- 资助金额:
$ 23.31万 - 项目类别:
Clinical Trials Network New England Consortium Node: Admin Supplement CTN0126
临床试验网络新英格兰联盟节点:管理补充 CTN0126
- 批准号:
10655828 - 财政年份:2022
- 资助金额:
$ 23.31万 - 项目类别:
The National Drug Abuse Clinical Trials Network: New England Consortium Node
国家药物滥用临床试验网络:新英格兰联盟节点
- 批准号:
10450554 - 财政年份:2021
- 资助金额:
$ 23.31万 - 项目类别:
The National Drug Abuse Clinical Trials Network: New England Consortium Node
国家药物滥用临床试验网络:新英格兰联盟节点
- 批准号:
10442107 - 财政年份:2021
- 资助金额:
$ 23.31万 - 项目类别:
EMBED: Pragmatic trial of user-centered clinical decision support to implement EMergency department-initiated BuprenorphinE for opioid use Disorder
EMBED:以用户为中心的临床决策支持的实用试验,以实施急诊部门发起的丁丙诺啡E治疗阿片类药物使用障碍
- 批准号:
9928151 - 财政年份:2018
- 资助金额:
$ 23.31万 - 项目类别:
EMBED: Pragmatic trial of user-centered clinical decision support to implement EMergency department-initiated BuprenorphinE for opioid use Disorder
EMBED:以用户为中心的临床决策支持的实用试验,以实施急诊部门发起的丁丙诺啡E治疗阿片类药物使用障碍
- 批准号:
10379284 - 财政年份:2018
- 资助金额:
$ 23.31万 - 项目类别:
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