A comparative effectiveness trial of extended release naltrexone versus extended-release buprenorphine with individuals leaving jail
缓释纳曲酮与缓释丁丙诺啡对出狱人员的效果比较试验
基本信息
- 批准号:10616501
- 负责人:
- 金额:$ 196.71万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-07-15 至 2025-04-30
- 项目状态:未结题
- 来源:
- 关键词:AccidentsAdherenceAdministratorAdverse eventAgonistAreaAwardBuprenorphineClinical TrialsCommunitiesContinuity of Patient CareCountyCrimeCriminal JusticeDeath RateDrug usageEffectivenessEnsureEpidemicEventFDA approvedFormulationFundingGenderHIV riskHIV/AIDSHealth PersonnelHealth systemImprisonmentIndividualInfectionInjectableInjectionsInterventionIntoxicationIntramuscularJailLearningLettersLiteratureMarylandMental HealthMethadoneNaltrexoneNeedlesOpiate AddictionOpioidOpioid agonistOverdosePatient Self-ReportPharmaceutical PreparationsPharmacotherapyPhasePolicy MakerPopulationPreventionPrisonerPrisonsPublic HealthQuality of lifeRandomizedRandomized, Controlled TrialsRegulationRelapseResearch DesignRisk BehaviorsSafetySex BehaviorSiteSubcutaneous InjectionsSupervisionTest ResultUrineWomanacceptability and feasibilityantagonistarmcomparative effectiveness trialcosteconomic valueeffectiveness evaluationeffectiveness/implementation trialheroin useillicit opioidimplementation facilitationinnovationmedication compliancemedication for opioid use disordermenopioid useopioid use disorderopioid withdrawaloverdose deathphysical conditioningpreferenceprescription opioidprescription opioid misuseprimary outcomeprogramsrandomized trialrandomized, clinical trialsrearrestreduced substance usereincarcerationrelapse preventionrisk minimizationscale upsecondary outcometreatment program
项目摘要
Abstract
The proposed study is a Type 1 hybrid effectiveness-implementation trial. Early adopters from
the Maryland extended-release naltrexone (XR-NTX) initiative and additional counties who are
willing to provide CAM2038, a new extended-release-buprenorphine (XR-B) formulation will
participate in a randomized controlled trial conducted in 7 counties (10 jails) throughout the state
of Maryland, in which 240 incarcerated men and women will be randomly assigned within
gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly
injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One
injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community
treatment program. Aim 1. To determine the effectiveness of XR-B compared to XR-NTX in
terms of: Primary. (a) pharmacotherapy adherence (number of monthly injections received).
Secondary. (b) illicit opioid urine test results; (c) self-reported illicit opioid use; (d) overdose
events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk
behaviors (i. sexual behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii.
re-arrest; iii. re-incarceration). Aim 2. To use a learning collaborative involving all 7 RCT county
jurisdictions as well as 3 additional counties that selected not to participate in the randomized
trial to understand factors related to: (a) acceptability of providing long-acting agonists and
antagonists in jail settings; and (b) feasibility of providing medication continuity of care from jail
to community treatment providers. Aim 3. Calculate the cost to the correctional health system of
implementing an XR-B or XR-NTX program, and determine the relative value of each strategy,
including the costs associated with the subsequent interventions in the community, from a state-
policymaker and societal perspective.
The proposed study is innovative because it would be the first randomized clinical trial in the US
assessing effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact
of the study will be highly significant and far-reaching because most individuals with OUD do not
receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to
drug use, overdose death, HIV/AIDS infection, and re-incarceration. Finally, understanding how
to expand acceptance of medications for opioid use disorder in jails, particularly long-acting
medications, has far-reaching implications for treatment expansion in this population.
抽象的
拟议的研究是 1 类混合有效性实施试验。早期采用者来自
马里兰州缓释纳曲酮 (XR-NTX) 计划和其他县
愿意提供 CAM2038,一种新的缓释丁丙诺啡 (XR-B) 制剂将
参加在全州 7 个县(10 个监狱)进行的随机对照试验
马里兰州,其中 240 名被监禁的男女将在
监狱内性别分为两组:第 1 组 XR-B (n=120)。 XR-B 入狱,随后入狱 6 个月
释放后在社区治疗计划中进行注射。第 2 臂。XR-NTX (n=120)。一
在监狱中注射 XR-NTX,释放后每月在社区注射 6 次
治疗方案。目标 1. 确定 XR-B 与 XR-NTX 相比的有效性
条款:主要。 (a) 药物治疗依从性(每月接受注射的次数)。
次要的。 (b) 非法阿片类药物尿液检测结果; (c) 自我报告非法使用阿片类药物; (d) 服药过量
事件(非致命和致命); (e) 生活质量(一、身体健康;二、心理健康); (f) 艾滋病毒风险
行为(i. 性行为;ii. 使用或共用针头); (g) 犯罪活动(i. 犯罪日;ii.
再次逮捕;三.重新监禁)。目标 2. 使用涉及所有 7 个 RCT 县的学习协作
司法管辖区以及另外 3 个选择不参加随机抽样的县
尝试了解与以下相关的因素:(a) 提供长效激动剂的可接受性和
监狱里的对手; (b) 在监狱中提供药物连续性护理的可行性
给社区治疗提供者。目标 3. 计算惩教卫生系统的成本
实施 XR-B 或 XR-NTX 计划,并确定每个策略的相对价值,
包括与随后的社区干预相关的成本,来自国家-
政策制定者和社会观点。
拟议的研究具有创新性,因为这将是美国第一个随机临床试验
评估县监狱中接收 XR-B 与 XR-NTX 的有效性。公共卫生影响
这项研究的意义重大且影响深远,因为大多数患有 OUD 的人并没有
在监禁期间接受治疗,从而大大增加了他们旧病复发的可能性
吸毒、吸毒过量死亡、艾滋病毒/艾滋病感染和再次监禁。最后,了解如何
扩大监狱中阿片类药物使用障碍药物的接受度,特别是长效药物
药物治疗,对于扩大该人群的治疗范围具有深远的影响。
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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Michael Scott Gordon其他文献
Michael Scott Gordon的其他文献
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{{ truncateString('Michael Scott Gordon', 18)}}的其他基金
Long-acting naltrexone for pre-release prisoners: A randomized trial of mobile treatment
长效纳曲酮用于释放前囚犯:流动治疗的随机试验
- 批准号:
10738933 - 财政年份:2023
- 资助金额:
$ 196.71万 - 项目类别:
A comparative effectiveness trial of extended release naltrexone versus extended-release buprenorphine with individuals leaving jail
缓释纳曲酮与缓释丁丙诺啡对出狱人员的效果比较试验
- 批准号:
10160255 - 财政年份:2019
- 资助金额:
$ 196.71万 - 项目类别:
A comparison of Sublingual and Extended-Release Buprenorphine for Individuals Leaving Jail
舌下含服和缓释丁丙诺啡对出狱人员的比较
- 批准号:
10547922 - 财政年份:2019
- 资助金额:
$ 196.71万 - 项目类别:
A comparative effectiveness trial of extended release naltrexone versus extended-release buprenorphine with individuals leaving jail
缓释纳曲酮与缓释丁丙诺啡对出狱人员的效果比较试验
- 批准号:
10388285 - 财政年份:2019
- 资助金额:
$ 196.71万 - 项目类别:
A comparative effectiveness trial of extended release naltrexone versus extended-release buprenorphine with individuals leaving jail
缓释纳曲酮与缓释丁丙诺啡对出狱人员的效果比较试验
- 批准号:
9978020 - 财政年份:2019
- 资助金额:
$ 196.71万 - 项目类别:
Buprenorphine for probationers and parolees: Bridging the gap into treatment
丁丙诺啡用于缓刑犯和假释犯:缩小治疗差距
- 批准号:
9898338 - 财政年份:2018
- 资助金额:
$ 196.71万 - 项目类别:
Buprenorphine for probationers and parolees: Bridging the gap into treatment
丁丙诺啡用于缓刑犯和假释犯:缩小治疗差距
- 批准号:
10610309 - 财政年份:2018
- 资助金额:
$ 196.71万 - 项目类别:
Buprenorphine for probationers and parolees: Bridging the gap into treatment
丁丙诺啡用于缓刑犯和假释犯:缩小治疗差距
- 批准号:
9900629 - 财政年份:2018
- 资助金额:
$ 196.71万 - 项目类别:
Long-acting naltrexone for pre-release prisoners: A randomized trial of mobile treatment
长效纳曲酮用于释放前囚犯:流动治疗的随机试验
- 批准号:
9689961 - 财政年份:2016
- 资助金额:
$ 196.71万 - 项目类别:
Continuing Care App for Probationers and Parolees with Substance Use Disorders
适用于患有药物滥用障碍的缓刑犯和假释犯的持续护理应用程序
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8997778 - 财政年份:2015
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