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,
在阿片类药物治疗计划(OTP)之外扩大美沙酮的使用。荟萃分析和CTN
0027证明美沙酮中的保留高于BUP。造成保留率低的因素
基于办公室BUP可能包括较低的激动剂活性、较差的BUP依从性、多种物质的使用
行为服务不足、患者偏好和共存疾病(即,慢性疼痛)。
临床医生目前有2种选择,用于无法从基于办公室的BUP中获益的患者。他们
可以尝试加强BUP服务或将患者转介到美沙酮OTP。我们建议
评估所需的新选择-基于办公室的美沙酮处方(根据研究豁免,
受管制物质法)与美沙酮配药在药房或药物配药单位。
同时,在美国,获得阿片类药物使用障碍的药物的特点是:
严重的种族和城市/农村差异也可以通过基于办公室的美沙酮来解决。
我们建议进行一项6个地点的混合有效性实施试验,以比较:1)
美沙酮,其中当前基于办公室的BUP处方者管理转换和继续
美沙酮与当地美沙酮配药机构(药房或其他OTP附属机构)合作
药物单位)与; 2)增强型BUP,其中办公室BUP提供者继续BUP
治疗,同时提供增强的行为治疗和/或实施策略,以解决
520例患者的依从性(如有指征)(直接观察治疗、每周三次BUP或缓释BUP)
未从基于诊室的BUP中获得最佳获益的患者。在目标1中,我们将培训6名大型办公室BUP
为美沙酮提供院外给药/配药。在目标2中,我们将评估
基于办公室的美沙酮与增强型BUP在治疗保留方面的比较有效性,
随机化后6个月。在目标3中,我们将使用混合方法和实现科学
确定患者、提供者和卫生部门实施障碍和促进因素的框架-
系统层面的办公室美沙酮。我们的团队包括早期研究人员,利益相关者
有生活经验的人,受过初级保健培训的研究人员,
医学/精神病学,临床试验,差异,定性研究和实施科学
在CTN开展研究、评价基于办公室的丁丙诺啡、基于办公室的
美沙酮和基于药房的美沙酮分发。这将是第一项研究:1)
利用经验丰富的BUP处方者,他们将学习处方美沙酮; 2)评估
有效性办公室为基础的美沙酮在高风险的病人没有被保留在BUP;和3)
评估病人和系统的障碍和促进者,以办公室为基础的美沙酮。
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)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Gail D'Onofrio其他文献
Gail D'Onofrio的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ 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:
相似海外基金
An innovative, AI-driven prehabilitation platform that increases adherence, enhances post-treatment outcomes by at least 50%, and provides cost savings of 95%.
%20创新、%20AI驱动%20康复%20平台%20%20增加%20依从性、%20增强%20治疗后%20结果%20by%20at%20至少%2050%、%20和%20提供%20成本%20节省%20of%2095%
- 批准号:
10057526 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
Grant for R&D
Improving Repositioning Adherence in Home Care: Supporting Pressure Injury Care and Prevention
提高家庭护理中的重新定位依从性:支持压力损伤护理和预防
- 批准号:
490105 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
Operating Grants
I-Corps: Medication Adherence System
I-Corps:药物依从性系统
- 批准号:
2325465 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
Standard Grant
Unintrusive Pediatric Logging Orthotic Adherence Device: UPLOAD
非侵入式儿科记录矫形器粘附装置:上传
- 批准号:
10821172 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
Nuestro Sueno: Cultural Adaptation of a Couples Intervention to Improve PAP Adherence and Sleep Health Among Latino Couples with Implications for Alzheimer’s Disease Risk
Nuestro Sueno:夫妻干预措施的文化适应,以改善拉丁裔夫妇的 PAP 依从性和睡眠健康,对阿尔茨海默病风险产生影响
- 批准号:
10766947 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
CO-LEADER: Intervention to Improve Patient-Provider Communication and Medication Adherence among Patients with Systemic Lupus Erythematosus
共同领导者:改善系统性红斑狼疮患者的医患沟通和药物依从性的干预措施
- 批准号:
10772887 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
Pharmacy-led Transitions of Care Intervention to Address System-Level Barriers and Improve Medication Adherence in Socioeconomically Disadvantaged Populations
药房主导的护理干预转型,以解决系统层面的障碍并提高社会经济弱势群体的药物依从性
- 批准号:
10594350 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
Antiretroviral therapy adherence and exploratory proteomics in virally suppressed people with HIV and stroke
病毒抑制的艾滋病毒和中风患者的抗逆转录病毒治疗依从性和探索性蛋白质组学
- 批准号:
10748465 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
Improving medication adherence and disease control for patients with multimorbidity: the role of price transparency tools
提高多病患者的药物依从性和疾病控制:价格透明度工具的作用
- 批准号:
10591441 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
Development and implementation of peer-facilitated decision-making and referral support to increase uptake and adherence to HIV pre-exposure prophylaxis in African Caribbean and Black communities in Ontario
制定和实施同行协助决策和转介支持,以提高非洲加勒比地区和安大略省黑人社区对艾滋病毒暴露前预防的接受和依从性
- 批准号:
491109 - 财政年份:2023
- 资助金额:
$ 23.31万 - 项目类别:
Fellowship Programs