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.
摘要
拟议的研究是1型混合有效性-实施试验。早期采用者来自
马里兰州延长释放纳洛酮(XR-NTX)倡议和其他县谁是
愿意提供CAM 2038,一种新的缓释丁丙诺啡(XR-B)制剂将
参加在全州7个县(10所监狱)进行的随机对照试验
在马里兰州,240名被监禁的男性和女性将被随机分配
监狱内的性别分为两组:第一组。XR-B(n=120)。XR-B在监狱里,然后是6个月
在社区治疗项目中进行注射。2号臂XR-NTX(n=120)。一
在监狱中注射XR-NTX,然后在社区释放后每月注射6次
治疗方案目标1.确定XR-B与XR-NTX相比在以下方面的有效性:
条件:初级。(a)药物治疗依从性(每月接受的注射次数)。
中学。(b)非法类阿片尿检结果;(c)自我报告的非法类阿片使用情况;(d)过量
事件(非致命和致命);(e)生活质量(即,身体健康; ii.(f)艾滋病毒风险
行为(i.性行为; ii.使用或共用针头);及(g)犯罪活动(i.犯罪日; ii.
再次逮捕; iii.再次入狱)。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个选择不参加随机化的县
试验旨在了解与以下方面相关的因素:(a)提供长效激动剂的可接受性,
监狱环境中的拮抗剂;以及(B)从监狱提供药物治疗和护理的可行性
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,并确定每种策略的相对价值,
包括与社区后续干预相关的费用,
政策制定者和社会观点。
这项拟议中的研究是创新的,因为它将是美国第一个随机临床试验。
评估在县监狱中接受XR-B与XR-NTX的有效性。对公众健康影响
这项研究将是非常重要和深远的,因为大多数人与OUD不
在监禁期间接受治疗,从而大大增加他们复发的可能性,
吸毒、过量死亡、艾滋病毒/艾滋病感染和重新监禁。最后,了解如何
扩大监狱中阿片类药物使用障碍的药物接受范围,特别是长效药物,
药物,对这一人群的治疗扩展具有深远的影响。
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:
9978020 - 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:
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
- 批准号:
8997778 - 财政年份:2015
- 资助金额:
$ 196.71万 - 项目类别:
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